“Content is king” is cliché marketing jargon, but in clinical product development, the cliché holds true. Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a study operates across cultures, countries, and continents, these pain points of cost, risk, and time are compounded by the addition of translation and localization requirements.  

Study team who can better anticipate their language needs, can better control for the above-mentioned pain points. With this in mind, we're thrilled to introduce the Ultimate Clinical Trial Translations Checklist, based on the comprehensive excel sheet attached.

Why Translations Matter in Clinical Trials

Clinical trials often span across various countries, each with unique languages and cultures. Below are just some of the reasons accurate, timely translations are essential in clinical R&D:

• Patient Safety: Effective patient communication protects patient safety and improves outcomes. Translated and localized content creates safer, more ethical studies.  
• Informed Consent: Patients cannot truly provide informed consent if they do not understand their rights, along with the study’s potential risks and benefits, as well as purpose and procedures.
• Regulatory Compliance: Complying with local regulatory standards is a must, and different countries have different requirements. Rejections create delays and incur costs.  
• Data Integrity: Protecting the validity of data is imperative and is supported by accurate translations that facilitate more reliable data collection.  
• Stakeholder Engagement: Effective collaboration across global stakeholders (sponsors, CROs, regulatory bodies, etc.) is also a source of risk, cost, and time pain points, which can be reduced through better communication via translations.  
• Patient Recruitment & Retention: Recruitment and attrition can be greatly improved through cultural relevancy.  
• Cultural Sensitivity: Related to the relevancy noted above, it is important for any and all communications that they are respectful of unique values, beliefs, and customs. Effective adaptation supports patient safety, collaboration, and overall success.  
• Reputation Management: No sponsor company wants to be perceived as out of touch, insensitive, or, worse, negligent. Attention to language in clinical R&D ensures a reputation of professionalism and patient centricity, among other positive sentiments.  

TransPerfect's Dedication to Excellence

At TransPerfect, we're committed to offering practical solutions and knowledge to manage the intricacies of product development. Our tools and resources are meticulously designed to assist organizations in navigating the complexity of global clinical trials. The Ultimate Clinical Trial Translations Checklist is just one of the many tools we've developed to support this mission.

More Tools to Enhance Your Clinical Trials

TMF Risk Score: Assessing inspection risk is no longer a time-consuming task. With our TMF Risk Score self-assessment, you can gauge your inspection risk in mere minutes. It's a game-changer for trial management, offering insights that can guide strategic decision-making for inspection readiness.

The Ultimate Clinical Trial Tracking Checklist: Clinical research is a nuanced and resource-heavy endeavor. Ensuring success means eliminating unnecessary costs, redundancies, and delays. Inefficient data collection, syncing, and reporting can prolong trial timelines and result in less informed decision-making. It's imperative for clinical leaders to equip their teams with top-tier tools that optimize clinical trial management and effectively reduce cycle times. Our Ultimate Clinical Trial Tracking Checklist offers:

• An expert perspective on study and site oversight scope.
• Insights on how risks influence clinical trial management.
• A detailed checklist to help you comprehend the clinical trial data you might need to track.
• Strategies to effortlessly manage, report, and understand your clinical trial data.
• Insights into the advantages of a CTMS for emerging biotech and pharma.

The clinical R&D landscape is ever evolving, making it important to have the right information and tools to mitigate risks, control costs, and protect timelines. TransPerfect is here to support and streamline your clinical trial processes. Explore the Ultimate Clinical Trial Translations Checklist and discover how it can help you anticipate language requirements for your global clinical trials.

Over the past few decades, clinical trials have witnessed remarkable developments - but they are not without challenges. Dropout rates of up to 20% indicate that patient burden and engagement remain key areas of concern. In response to this, sponsors, healthcare providers, and researchers have emphasized the importance of putting patients at the heart of every decision in clinical trials. 

As these efforts continue, the task at hand is finding the right balance between putting patients first and extracting the data required to advance the research. It’s a delicate balance to minimize the burdens on patients and still get the assessments done. Things like decentralized clinical trials (DCTs) and remote patient monitoring aim to reduce the burden on patients. The initial step is comprehending each individual's identity, values, and priorities. By adopting a holistic perspective that goes beyond their "patient" role - which is just one part of their life - we can better understand potential difficulties with schedules or procedures. This approach enables us to proactively reduce discomfort and inconvenience. By taking stock of what the patient values, and making decisions based on this, we can ensure clinical research remains grounded in ethics and empathy, thus maximizing the benefits of patient-centricity while minimizing any adverse impact on patients' well-being and participation.  

Let’s assess how patient centricity efforts take patient burden into account, and how providers can establish benchmarks for understanding when the risk begins to outweigh the reward in clinical research.  

Patient Centricity - An Ongoing Journey 

Patient centricity is an ongoing journey that healthcare and clinical research communities are committed to pursuing. The goal is to ensure that every aspect of patient care, from clinical trials to treatment plans, is tailored to individual patient needs and preferences. By involving patients in decision-making processes, fostering transparent communication, and addressing patient concerns, we cultivate a more supportive and empowering healthcare ecosystem. 

The positive impacts of patient centricity are manifold. Designing clinical studies in alignment with patient needs leads to higher recruitment and retention rates in clinical trials. In healthcare settings, patient-centric approaches enhance treatment adherence and overall patient satisfaction. Furthermore, patients who feel heard and valued are more likely to actively participate in their own care, amounting to better health outcomes. For example, many studies demonstrate provider action to remediate patient discomfort. In the case of hospitals, many conducted menu overhauls when the food was trialed by executive healthcare staff and found to be sub-par. 

The Burden on Patients - Analyzing the Cost of Improvement 

The trade-off for the promise of improved treatments and cures may necessitate time and effort from patients. Some examples of this may be: frequent site visits, physical and emotional exertion, and the possibility of experiencing adverse events from investigational treatments. The challenge becomes even more emphasized when patients are required to travel long distances to distant trial sites (which may be difficult depending on their physical condition), incur additional expenses, or disrupt their daily routines. For example, many trial participants stress that time away from work is both a significant scheduling and financial burden.   

Considering clinical trials, in addition to standard care options, can add an additional layer of complexity to treatment decision-making, leading to information overload and decision fatigue for patients. The plethora of medical information, such as 25+ page informed consent forms (ICFs), technical terminology, and treatment options can be overwhelming, particularly for individuals facing serious health conditions. The consequences of this burden may be far-reaching, potentially compromising the quality of care and patient outcomes. Furthermore, patients may be pushed to accept standard care due to concerns about not being placed on an active drug in the case of placebo-controlled trials.  

Is It Worth It? - Evaluating the Tipping Point 

A study investigating the perceived burden of oncology patients during a trial revealed that, among patients who chose to withdraw from the research, 33.3% perceived the benefits of participation as being less than the burdens. By contrast, 13.4% of those who withdrew from trial participation perceived the benefits as being equal to or greater than the burdens. These findings suggest that to increase retention, more stakeholder input is needed to focus on patient-focused benefits throughout the trial. Stakeholders must be mindful of the tipping point between the potential benefits and burdens that clinical trials can impose on patients. 

In some instances, patients may display a remarkable willingness to endure significant burdens if the anticipated outcome offers hope for alleviating pain, reducing discomfort, or extending life expectancy. For these individuals, the temporary inconvenience associated with trial participation may be deemed worthwhile in pursuit of improved health outcomes, increased quality of life, and living to witness significant life events like having children, getting married, etc. 

However, an essential facet of patient-centricity lies in recognizing that there are indeed limits to what patients can endure. In many cases, reported impediments may be proactively anticipated and mitigated to ensure minimal disruption. Striking the balance between encouraging increased patient involvement and reducing patient burden necessitates a thoughtful evaluation of the potential barriers involved in participation and considering the nuances of individual patient circumstances. 

Patient-Centric Strategies - Accounting for Nuance 

To truly achieve patient-centric approaches that optimize outcomes while minimizing burden, healthcare and research communities must adopt strategies that consider the nuance of individual patient needs. Key considerations include: 

Individualized Approaches: Recognize that each patient's circumstances and preferences are unique, then tailor care plans and trial designs to accommodate individual needs. Examples may include leveraging decentralized trial modalities to accommodate patients located extensive distances from sites, or enabling remote participation to reduce physical burden. 

Clear Communication: Provide transparent information about treatment options, clinical trial protocols, and potential risks and benefits. Ensure patients fully understand their choices and conduct qualitative research methodologies to assess patient clarity.  

Informed Consent: Obtain informed consent from patients, acknowledging their understanding of the potential burden and benefits of participating in the trial. Furthermore, ensure informed consent is obtained at an appropriate level, including pictures or graphics to aid comprehension.  

Supportive Services: Offer support services to help patients manage the burden of participation, such as transportation assistance, caregiver support, or remote patient monitoring options. 

Shared Decision-Making: Engage patients as partners in their healthcare journey. Encourage shared decision-making to ensure alignment with patient preferences, and monitor patient feedback and engagement to mitigate burden and maximize patient comfort.  

Conclusion - Empowering Patients, Balancing Outcomes.  

A core component of patient centricity lies in recognizing and respecting the limits of patient endurance. The willingness to endure burdens is not unlimited, and it requires thoughtful risk vs. benefit analysis. By adopting strategies that embrace individualization, clear communication, informed consent, and supportive services, researchers can better optimize patient experiences and foster a healthcare ecosystem that truly focuses on patient well-being and comfort throughout all stages of the trial lifecycle. 

At TransPerfect Life Sciences, we are committed to deeply understanding the patient experience and removing points of friction throughout the patient journey. By recognizing each patient as a unique individual with a life and identity beyond their "patient" role, we can engage seamlessly with communities and meet patients' requirements while effectively contributing to scientific advancements through their participation in clinical trials.  

Monitoring patient engagement and evaluating the burdens placed on trial participants is one component of a successful patient recruitment, retention, and engagement strategy. Learn more about how unburdening patients, in addition to amplifying the patient voice, can help optimize clinical research participation and retention in our white paper: Patient Recruitment: The Regrettable Spend.  

Want to unlock success in your patient engagement strategy today? Reach out to our teams to get started. 

In 2019, Health Canada initiated a significant process to transition all product monograph templates into a more advanced and structured XML format. This move by the regulatory authority has raised several questions for Canadian pharmaceutical organizations' regulatory and content teams. Beyond requiring adaptation to a new format, the question arises on whether this development will merely result in an isolated structural content change, or if it could revolutionize content management strategies in the Canadian healthcare landscape. 

As the industry steadily embraces technological advancements, the decision to shift to XML-based templates presents both opportunities and challenges for pharmaceutical companies, healthcare providers, and regulatory professionals alike. In the same vein, this transition signifies an important step toward a more optimized and refined future of automation. It prompts reconsideration of how teams traditionally author, reuse, and deploy content across different channels, introducing what may be perceived as a novel and innovative approach by industry veterans.  

Benefits of XML Formats & Industry Growth 

Health Canada's XML mandate requires pharmaceutical companies to adopt XML as the preferred format for preparing and submitting regulatory content. This encompasses all drug submissions, including New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), and supplemental submissions.  

This format structures and represents data in a hierarchical manner, leveraging tags to describe components and offering a plethora of advantages, both for regulatory authorities and pharmaceutical companies. Some such advantages include: 

1. Enhanced Data Integrity: 

The use of structured content ensures consistency and accuracy. By employing XML's standardized format, critical information is organized systematically, minimizing the risk of transcription mistakes. 

2. Improved Interoperability:  

XML facilitates the easy sharing and compatibility of regulatory data across various systems, streamlining interoperable workflows.  

3. Streamlined Submission Review:  

XML's standardized tagging enables automated data processing capabilities. Users can leverage advanced software tools and applications specifically designed to extract, analyze, and validate information from XML files to streamline and enhance review procedures. 

4. Facilitating Global Harmonization:  

Health Canada's move aligns with the global harmonization efforts in the pharmaceutical industry. The shift to XML format facilitates smoother cross-border submissions and reduces the burden of multiple formats for global pharmaceutical companies. 

5. Enhanced Data Analysis:  

XML's structured nature facilitates data mining and analysis, enabling regulatory authorities to gain valuable insights from large datasets. This data-driven approach can lead to more informed decision-making and regulatory policy improvements. 

XML Product Monograph Phases of Implementation 

The implementation of the XML requirements has been broken down into the following phases: 

• Phase I – “Limited” Production Submissions: By request only 

• Phase II – “Voluntary” Production Submissions: Open to industry 

• Phase III – “Mandatory” Product Submissions: New/changed product monographs 

• Phase IV – “Mandatory” Product Submissions: Legacy product monographs 

Currently, we are in Phase II: Full Production (Voluntary). which began in the spring of 2021. Health Canada has intentions to make the XML format a mandatory requirement with the launch of Phase III: Full Production (Mandatory). The launch date for Phase III will be announced after evaluating the results of Phases I and II.  

This pioneering XML mandate marks a momentous leap toward a more efficient, standardized, and data-driven future for the pharmaceutical regulatory landscape. While the transition may present initial challenges, the long-term benefits promise to revolutionize the way we approach drug submissions and ultimately serve patients.  

Pharmaceutical companies seeking to comply with the mandate should implement a robust transition framework, including putting the necessary infrastructure, resources, and expertise in place for XML content creation and submission. This may require training regulatory teams on XML standards, adopting XML authoring tools, and working closely with third-party providers or consultants specialized in XML-based submissions. 

By embracing an XML future, pharmaceutical companies can wield a transformative influence on the ever-changing regulatory landscape. In this era, where clinical studies and market access protocols swiftly adapt to interconnected and dynamic research methodologies, the question emerges: "What lies ahead for pharma?" In Canada, the answer to this crucial query lies in a subtle yet pivotal shift in regulatory requirements, propelling Canadian pharmaceutical organizations to an unprecedented level of prominence on the global stage. 

For the last three decades, TransPerfect Life Sciences has grown with pharmaceutical organizations as they expand their global reach and navigate shifting regulatory markets. Our regulatory solutions help enable organizations to control their content in the changing environment, providing strategy, support and detailed execution of regulatory initiatives. 

Contact us today to stay ahead of industry developments and drive innovation in global life sciences with our XML Solutions.  

Introduction:

In the field of clinical research, a robust data management process is essential for driving success. Efficiently handling vast amounts of data, ensuring accuracy and consistency, and extracting meaningful insights are vital, particularly in the case of global clinical trials. 

The volume of data collected throughout a clinical trial is dependent on several factors, such as the trial scope, the number of participants, and which endpoints are being evaluated. This includes structured data, such as patient demographics and lab results, as well as unstructured data, such as trial notes, imaging files, and patient-reported outcomes. In recent times, an increase in digital health technologies aims to keep up with the growing volumes of data collected, both in real-world and clinical applications. 

It is, nonetheless, becoming continually complex to manage, store, analyze, and act on this data without an effective assessment of existing technology frameworks and management strategies. Research teams should assess their existing processes and identify potential gaps, which may be creating inefficiencies or incurring high costs/resources.

Current Industry Trends and Problems in Clinical Data Management Workflows:

As datasets continue to grow, so do the many challenges that can impact how efficiently the data itself is leveraged on a broader scale. Some of these complexities include: 

Manual Data Entry and Verification: 

Spending extensive hours inputting data from paper forms or disparate electronic sources is a time-consuming, error-prone process, often resulting in inconsistencies or inaccuracies. Manual verification of this data exacerbates the issue, causing delays and jeopardizing data quality.

Teams that rely on manual data may face complications when reconciling and cross-checking data across multiple sources, leading to discrepancies and requiring extensive data clean-up.

Disparate Data Sources and Inefficient Integration: 

Clinical trials generate large datasets from various sources, such as electronic health records, patient-reported outcomes, lab results, and wearable devices. However, these data sources often operate separately, making it difficult to integrate and harmonize the data. An inefficient integration process can result in fragmented and siloed data, hindering the ability to derive comprehensive insights. Furthermore, teams may find themselves duplicating efforts, increasing time consumption, and potentially missing critical data points.

Inadequate Data Standardization and Governance: 

Non-standardized data collection processes and inconsistent formats may hinder efforts for efficient data management. A lack of proper data governance frameworks and standardized protocols causes data quality, comparability, and interoperability to suffer. Ultimately, this makes it difficult to conduct meaningful cross-study analyses or leverage data for post-trial analysis and real-world evidence generation. Furthermore, difficulties that arise when aggregating and analyzing data across multiple sites or studies can impact research outcomes.

Limited Utilization of Automation and AI/ML Technologies: 

Underutilizing automation and advanced technologies, such as artificial intelligence (AI) and machine learning (ML), is another roadblock to effective clinical data management. Manual and repetitive tasks, such as data clean-up and adverse event identification, are optimal candidates for automation using AI/ML algorithms, with the outcome of improved efficiency and reduced human errors. Without leveraging these algorithms, researchers could spend valuable time and resources manually reviewing adverse events, leading to potential delays in identifying and highlighting safety concerns.

Bridging the Gaps with Technology-Driven Solutions:

In clinical research, selecting one system over another may not be as straightforward as it seems. In many cases, a combined approach that outlines clearly defined roles for respective systems can maintain existing frameworks while bridging gaps where necessary. Acknowledging current limitations can guide a more effective evaluation of which systems should be implemented.

Once clinical teams have conducted a thorough analysis of existing systems, there are several technology-driven solutions available to streamline workflows, enhance efficiency, and optimize data management processes. Some examples include:

Component Content Management Systems (CCMS):

A CCMS is focused on content details, or “components,” in files designed to centralize document management. By centralizing all clinical content, such as investigator brochures, protocols, patient consent forms, and regulatory materials, a CCMS enables information storage and retrieval.

In cases of multilingual clinical materials, the system’s content reuse capabilities enable researchers to establish consistency across trial materials by tapping into and repurposing pre-approved content. This subtracts the need for further data compilation and duplicated creation efforts while reducing the time and costs associated with creating content from scratch.

Translation Management System (TMS):

A TMS leverages a centralized database known as a translation memory (TM), which stores existing content and translated segments, including clinical technical terminologies or specific languages. This enables translators to reuse pre-approved content and ensure consistency across multiple languages. This also eliminates the need for data compilation and duplicated creation efforts. As a result, the time and costs associated with creating content from scratch are significantly reduced.

By reducing turnaround times and optimizing the translation process, TMS tools enable researchers to focus on critical tasks and improve overall operational efficiency. Moreover, the automation and standardization provided by TMS eliminate the administrative burden associated with translating materials for different sites, resulting in cost savings and increased productivity.

Clinical Trial Management Systems (CTMS):

Clinical Trial Management Systems (CTMS) play an essential role in alleviating the burdens associated with clinical trial data management. A comprehensive CTMS platform offers a range of features designed to streamline workflows by centralizing trial information and offering real-time insights.

With a CTMS, research teams work out of a central system that integrates with other technologies, such as document management systems, electronic data capture (EDC), and reporting/analytics tools. These integrations create a holistic ecosystem that enables researchers to monitor multiple clinical activities throughout the trial lifecycle, eliminating the need for manual data entry and providing visibility throughout all stages of a clinical trial. The automation of data collection and tracking in a CTMS also reduces the administrative burden on trial personnel, allowing them to focus more on critical tasks and data analysis.

Moreover, CTMS platforms can track key performance indicators (KPIs) to provide insights into trial progress and measure performance. By generating comprehensive reports and analytics, a CTMS can empower trial teams with actionable data to make well-informed decisions and identify potential gaps in the process. Incorporating a data-driven approach through a central technology framework can ultimately improve process efficiencies, accelerate timelines, and contribute to the overall success of clinical trials.

Artificial Intelligence and Machine Learning Technologies: 

AI and ML technologies have transformed the way clinical trial data is processed and analyzed. These tools can rapidly sort through large amounts of clinical data, identify patterns, and extract meaningful insights. For example, predictive analytics tools can optimize patient recruitment and retention efforts, identify potential safety risks, and empower more data-driven approaches to decision-making. AI-powered algorithms can also automate data clean-up, minimize human errors, and ensure data accuracy.

Furthermore, AI/ML tools can identify key data points in the discovery and development phases of clinical research, including relevant biomarkers; stratify patient populations; and assess potential treatment responses. By identifying specific patterns and correlations in large datasets, AI systems offer critical insights into disease mechanisms, treatment efficacy, and adverse events. These contributions accelerate the drug discovery and development processes, demonstrating how AI/ML frameworks improve research data and, consequently, patient outcomes through more efficient and effective clinical trial management and analysis

Conclusion:

Research teams seeking to overcome challenges, improve efficiency, reduce costs, and accelerate timelines should assess how these solutions may fit into existing frameworks and alleviate some of the pain points in their clinical operations. Automation, advanced technology, and centralized systems enable researchers to focus on critical tasks and drive better patient outcomes while keeping costs low and turnaround times on track. 

By leveraging technology effectively, researchers can unlock the full potential of data, leading to more advancements in clinical research and improved healthcare outcomes.

Want to get started with optimizing your clinical operations and maximizing your research teams’ abilities? Reach out today to learn how TransPerfect Life Sciences can inform your data management strategy. 

Introduction:  

In the rapidly evolving landscape of life sciences marketing, implementing an effective omnichannel strategy is crucial to driving positive customer experiences and increasing engagement. By seamlessly integrating multiple channels and considering the needs of not only global but local affiliates, organizations can unlock ample opportunities to expand their reach and connect with markets on a meaningful level.  

An omnichannel strategy integrates various channels to provide a smooth and consistent experience for providers, patients, and other stakeholders. Unlike multichannel marketing, which uses multiple independent channels, omnichannel marketing ensures that all of these channels are interconnected and work together to deliver a unified message and experience. During our latest session at NEXT Pharma Summit, we explored the key considerations when implementing a global-to-local strategy in the life sciences industry and how to ensure success in your omnichannel rollout on a global and local scale.  

Featured Speakers During This Session Included: 

• Ewelina Knigawka – Executive Director of Content & Partnership Excellence, Novartis 
• Scott Dille – Digital Content Lead, Novo Nordisk 
• Christine Buggle – Senior Director, TransPerfect Life Sciences 

Why an Omnichannel Strategy? 

A successful omnichannel strategy delivers a superior customer experience. While buzzwords like "omnichannel" can be misleading, it is essential to understand that true omnichannel capabilities are still a work in progress. However, by focusing on meeting customer expectations by delivering high-quality content, organizations can lay the groundwork for a successful omnichannel approach as presently defined.  

Key Challenges  

Implementing a global-to-local strategy in the life sciences industry comes with its fair share of challenges. One significant hurdle is the medical, legal, and regulatory (MLR) approval process. Despite careful planning and discussions, the MLR process often results in numerous comments and delays. To mitigate this challenge, organizations must establish a clear strategy, deliver content aligned with that strategy. Timeliness is also crucial, as meeting deadlines is often a struggle in this industry. 

Delivering a consistent and seamless customer experience across various channels and touchpoints involves managing a complex ecosystem of communication channels, platforms, and technologies. Part of this often requires adapting content to different languages and cultural contexts. Striking the right balance between accuracy and adaptability is crucial. Another part of the translation process is transcreation, or creatively adapting content while preserving its intent and impact. This is vital to ensure messaging is not diluted or lost in translation. Engaging a vendor with the appropriate technology frameworks to manage scalable translation workflows can mitigate the challenges associated with maintaining quality and consistency through the translation process.  

What Drives a Successful Omnichannel Strategy? 

Standardization:

• A key component of a successful omnichannel marketing strategy for consistency across markets.
• Involves establishing processes and guidelines across different channels for a unified brand experience.
• Pharmaceutical companies can implement brand guidelines for visual elements, language style, and content structure to ensure consistency across various platforms.

Consideration of Local Markets:

• Critical for a successful omnichannel rollout.
• Requires deep understanding of local healthcare landscape, regulations, culture, and preferences.
• Engaging local affiliates is essential to align with the overall company direction and cater to target audience needs.

Center of Excellence (CoE):

• Plays a crucial role in ensuring omnichannel strategy success.
• Facilitates sharing of best practices and capabilities optimization.
• Balances centralization and localization through strategy alignment and efficient content delivery.
• Serves as a central hub of expertise and resources, guiding content creation, digital marketing, and technological solutions.
• Tailors strategies to consider unique nuances of local markets for effective execution.

Conclusion:  

A successful omnichannel marketing strategy requires delivering a seamless and personalized customer experience across channels while prioritizing local market needs.  

Accurate translation, cultural adaptation, and transcreation play a pivotal role in global customer engagement. Ensuring that your content resonates with audiences in any market requires expertise in language services.  

At TransPerfect Life Sciences, our team of experts can help develop and deliver strategic omnichannel marketing campaigns. We work to understand and form a strong content plan that is relevant and appropriate for your audiences while helping you access and optimize digital channels to engage global audiences at scale with targeted, multilingual marketing. Reach out today to get started. 

Introduction:

Expanded access programs (EAPs) provide pathways to treatment options prior to local marketing authorization in cases where traditional clinical trial participation is not feasible. Usually, these treatments involve investigational therapies (i.e., drugs, biologics, and medical devices) that have not yet been approved by the relevant regulatory bodies, such as the Drug Administration of Vietnam (DAV); the Ministry of Food and Drug Safety (MFDS) of South Korea; The National Agency for the Safety of Medicines and Health Products (ANSM) of France; or the MoH (MPPS) division of drugs, medicines, and cosmetics from Venezuela. 

With the pandemic over and a drive for international collaboration and equity on the rise, the expansion of these access programs has been a focus for many in the scientific research community. And with this, the regulatory landscape has been adapting accordingly. On a global scale, regulations and ethical considerations vary, with different bodies mandating specific conditions under which EAPs can be permitted. 

For example, the approval of an EAP may be dependent on the patient fulfilling one or more of the following criteria:

• The patient is suffering from a serious or life-threatening condition;
• There is a lack of alternative, satisfactory treatment;
• The patient is unable to participate in a clinical trial;
• The benefits of the therapeutic regimen outweigh the risks; and/or
• The treatment does not interfere with the ongoing drug development process.

Regulatory Considerations

The global regulatory landscape for EAPs is continuing to evolve. In recent years, several countries, including France, Lithuania, Kenya, and Ukraine, have introduced/updated/clarified regulations to facilitate access to unapproved treatments for patients with serious illnesses. Additionally, some countries, such as the United Kingdom, have introduced legislation to protect patients who participate in EAPs from legal action if the product causes harm.

Overall, the regulatory landscape for EAPs is changing rapidly. Drug manufacturers are now able to provide access to their products to patients with serious illnesses while still meeting regulatory requirements. 

In 2020, France implemented a new regulation that allows EAPs to provide access to unapproved drugs to patients with life-threatening or seriously debilitating conditions. This regulation was driven by real-world data showing that EAPs could provide access to potentially life-saving treatments for patients who do not qualify for clinical trials or have exhausted all other treatment options. The regulation requires that EAPs be approved by the French National Agency for the Safety of Medicines and Health Products (ANSM) and that they be conducted in accordance with the principles of Good Clinical Practice. In addition, the regulation requires EAPs to be conducted following the principles of transparency, patient safety, and ethical considerations.

Country-specific regulatory frameworks for EAPs are unified to ensure patients have access to critical medications when alternatives are not an option. Under this common goal, healthcare providers and regulators are implored to collaborate and communicate effectively to ensure mutual understanding of the requirements, risks, and operational considerations before providing an exception for critical patient use. However, they may differ on the regulatory submission process to the MoH, monitoring or reporting requirements, labeling, the number of patients allowed before different requirements are instilled, or the distribution and duration of providing the treatment commitments.

The pathway for obtaining authorization for this type of program can be complex with several variables to consider. Complexities can be further compounded when clinicians or providers are not familiar with the process or in some countries where the patient must apply directly for access.

These examples are non-exhaustive, as all parties must continue to comply with diverse country requirements for developing EAPs, which must, in turn, comply with new batch imports and renewed regulatory submissions. It is up to the drug manufacturer/future marketing authorization holder to approve or decline such requests when initiated by prescribers, as they deem appropriate.

Driving Compliance in Early Access to Medicines for Critically Ill Patients

In the US, the 21st Century Cures Act requires that a company developing investigational drugs (including biologics) shall make its policy regarding evaluating and responding to requests for expanded access public and readily available. This should be considered as the first step for any drug developer to define their approach to such requests. 

Ensuring compliance with all local regulatory requirements is an overarching, critical aspect of the expanded access pathways. Providers and drug manufacturers require up-to-date knowledge and understanding of the current local regulatory requirements wherever their patients are located around the globe. They should also ensure the provision of the necessary paperwork and forms, such as Form FDA 3926 in the US or any other local forms, informed consent, treatment protocols to the Institutional Review Board (IRB), safety reporting for adverse event monitoring, and logistics for global distribution and provision of the drug to the patient, factoring in specific importation and dispensation constraints that may exist.

Furthermore, ensuring compliance with complex and evolving regulations within the EAP pathway can be complemented by automating and validating the regulations. This simplifies the process for healthcare providers, pharmaceutical companies, and regulators when managing necessary documentation and reporting. 

Conclusion

A successful EAP application hinges on a collaborative effort among healthcare providers, pharmaceutical companies, patients, and regulators. Despite variations in regulatory frameworks globally, the goal across the board is consistent—ensuring timely access to essential treatment options for patients with severe illness, following the exhaustion of all other options. Despite the challenges associated with early patient access to medicines, TransPerfect can mitigate bottlenecks in country regulatory intelligence monitoring to confirm EAP regulations. 

Demystifying regulatory complexities and unburdening your teams can be seamless. Connect with us today to learn how TransPerfect Life Sciences' comprehensive suite of regulatory solutions provides expert insights and powerful automation tools designed to streamline approval processes for regulatory pathways.

Clinical trials play a crucial role in advancing medical research and improving healthcare outcomes. Traditionally, they have primarily focused on objective measures and quantitative data to evaluate the safety and efficacy of treatments. In recent years, there has been a growing recognition of the importance of incorporating patient perspectives and experiences into the process. Qualitative interviews have emerged as a valuable research tool for enhancing the overall quality and relevance of clinical trials. In this blog post, we will explore the significant role of qualitative interviews, specifically concept elicitation (CE), cognitive debriefing (CD), patient experience (PE), and exit interviews (EI), in achieving a patient-centered approach to clinical trials, as well as discuss some best practices in coordinating and conducting these types of interviews.  

 What are Qualitative Interviews?  

Qualitative interviews focus on exploring and understanding complex phenomena through the collection of detailed narratives. These interviews are typically open-ended and semi-structured, allowing participants to express their thoughts, opinions, and experiences in their own words. Comparatively, quantitative interviews aim to gather structured data for statistical analysis to identify patterns and draw generalizable conclusions. Clinical trials have historically collected quantitative data through questionnaires or surveys with predetermined questions and response options but are beginning to incorporate CEs, CDs, PEs, and EIs into the clinical trial timeline to augment these findings.  

CE describes the process by which symptoms and impacts (concepts) are identified as significant, and therefore necessary for inclusion in a clinical outcome assessment (COA). These interviews are usually conducted in the early phases (IIA and IIB) before the patient has started treatment. The concepts are identified spontaneously and are then used to develop the COA for use in the clinical trial. Investigation into endpoint models is particularly important for rare diseases, for which there is a lack of detailed knowledge about the course of the diseases. This process, in conjunction with the inclusion of traditional anchor- and distribution-based statistical methods, ensures that the COA can more accurately capture an important or meaningful change to a specific patient population. 

CE differs from CD in that the latter serves to test the conceptual equivalency and content validity of a specific COA measure. CD interviews are slightly more structured and assess patients’ comprehension and interpretation of the COA language, as well as determine the language’s cultural relevancy to a specific population. Interviews use a “talk aloud” method to determine a patient’s level of understanding on how to complete the questionnaire, reference the correct recall period, use response scales, and troubleshoot any additional instrument features that might unknowingly affect their responses when answering the COA in a clinical setting. 

PE interviews provide insight into a wide range of topics depending on when they are conducted during a clinical trial. Feedback solicited from interviews during Phase III can be included in “Patient Experience” or “Value Messages” in labels and FDA reviews. In later phases, such as Phase IV, these can help identify key challenges to participation and thus improve patient retention and adherence to medication. Improvements to the structural design of the trial can be implemented by asking patients for their opinions on the quality of the information provided during the trial and whether interactions with site staff are meeting their expectations. 

EIs are conducted whenever a patient leaves a clinical trial. The purpose is to identify any reported symptom changes that were experienced throughout the trial—for example, benefits, tolerability, and other unintended effects. Patients discuss their evaluations of the treatment and their experiences participating in the clinical trial. These findings are then summarized and used to provide a better understanding of the disease, treatment regimen, and operation of the clinical trial. Some consider these interviews to be the best method for obtaining qualitative, meaningful change insights, since the patient has already completed treatment by this point and has most likely experienced some sort of change. 

The inclusion of CEs, CDs, PEs, and EIs in a clinical trial provides a nuanced approach to gathering valuable patient insights that have traditionally been missing from the collection of quantitative data. Regulators, policymakers, and industry experts are increasingly highlighting the value of these types of interviews.  

7 Points to Consider for Successful Interviews:  

Conducting qualitative interviews requires careful planning and implementation to ensure that the insights gathered from participants are accurate, meaningful, and representative. The following points outline key interview techniques and considerations:  

1. Thorough training with sponsor-provided materials: Prior to scheduling interviews, training sessions with each interviewer should be held to review all relevant interview materials (e.g., interview guide, demographic health forms, etc.) and provide an opportunity for the sponsor to highlight anything they would like the interviewer to focus on. The training should include a general overview of the study’s purpose and research methods, so interviewers can answer any questions pertaining to the trial. Investigators and site staff should also receive training on the different types of interviews included in the trial, so they understand the significance of each type and can foster patient participation and cooperation.   

2. Building rapport and creating a comfortable environment: Establishing a rapport with participants is crucial to encourage open and honest dialogue. Researchers should create a welcoming and non-judgmental atmosphere, allowing participants to feel at ease while sharing their experiences. Active listening, remaining neutral, and respect for participants' perspectives are essential for fostering trust and creating a safe space for open communication. 

3. Interview structure: Qualitative interviews are typically semi-structured, meaning that they have a general framework with flexibility for participants to express their thoughts and experiences freely. Researchers may begin with broad, open-ended questions to encourage participants to share their narratives, followed by more specific probes to delve deeper into relevant topics. It is important to strike a balance between providing guidance and allowing participants to shape the conversation.  

4. Probing techniques: Skilled interviewers employ various probing techniques to elicit comprehensive responses from participants. These techniques include clarification (requesting additional details or examples), reflection (repeating or summarizing a participant’s statements to confirm understanding), and elaboration (encouraging a participant to provide more in-depth explanations). Probing ensures a deeper exploration of participants' perspectives and helps uncover underlying motivations and emotions. 

5. Sensitivity to cultural and linguistic diversity: Clinical trials often involve diverse populations with varying cultural backgrounds and languages. Researchers must be sensitive to these differences and adapt their interview techniques accordingly. The interviewer should be fluent in the patient’s primary language, preferably in their local dialect. This allows the interview to be conducted in culturally appropriate language and terminology, and ensures the interviewer is mindful of potential cultural biases or misunderstandings.  

6. Ethical considerations: As part of good clinical practices, researchers must prioritize participant confidentiality, privacy, and informed consent. Participants must be fully informed about the purpose of the interview, how their data will be used, and their rights as research participants. Researchers should also consider potential emotional or psychological distress that participants may experience during the interview and provide appropriate support or resources, such as referral to counseling services if needed.  

7. Recording, transcribing, and translating interviews: To ensure accuracy and thorough analysis, interviews should be recorded (with participant consent) and transcribed verbatim. Transcriptions serve as a permanent record of the interview and allow for detailed analysis. Assigning pseudonyms or identifiers during transcription and subsequent reporting protects patients’ anonymity. If translations of the transcription are required, it is imperative that a highly qualified translator with experience in medical translation and an understanding of clinical trials is selected.  

By following these techniques and considerations, researchers can effectively gather rich and meaningful data from qualitative interviews. TransPerfect Life Sciences has an established network of interviewers in 70+ countries who have been trained according to the aforementioned techniques. We work closely with researchers to ensure all interviews are conducted according to clients’ and sponsors’ specifications. Our translation and transcription teams are ISO 17100:2015 certified, guaranteeing a top-quality end product.   

Conclusion:  

Incorporating qualitative interviews into clinical trials represents a paradigm shift toward a patient-centered approach. By understanding and integrating the patient's voice, qualitative interviews provide valuable insights into patient experiences, preferences, and priorities. This approach ultimately leads to more relevant clinical trials that improve patient outcomes and enhance the quality of healthcare. As the healthcare landscape continues to evolve, the integration of qualitative interviews will play an increasingly vital role in shaping patient-centered clinical trials and advancing medical research.  

As an industry leader, TransPerfect Life Sciences is your ideal global partner, providing specialized end-to-end support for patient-centered outcomes research. As a trusted partner to CROs and sponsors, TransPerfect offers a comprehensive range of interview services, including concept elicitation, patient experience, and exit interviews. Reach out today to get started.  

Electronic Clinical Outcome Assessment (eCOA) wearables have been a major player in the collection of large volumes of patient-reported data. With clinical research generating large and complex datasets at a rapid rate, the value of eCOAs is increasingly apparent, offering new levels of healthcare innovation and convenience in data collection and analysis. In 2022, the value of the global eCOA solutions market was valued at $1.36 billion, with this figure expected to maintain an annual growth rate of 15.2% between 2023 and 2030. Furthermore, experts predict that wearables, namely digital sensors, will be incorporated into 70% of all clinical trials moving forward. 

With wearable devices growing more sophisticated, user-friendly, and customizable to individual patient needs, there is significant potential for enhancing patient engagement, compliance, and health outcomes. However, collecting and managing these large datasets is the next challenge researchers face with the increased use of COA wearables.

Advantages of eCOA Wearables

A key feature of eCOA wearables is the capacity to collect large quantities of real-time, continuous PRO data throughout the duration of a trial. Wearables are currently siloed into four distinct groups:

• Wearables/sensors – pulse oximeters and heart rate monitors
• External devices – movement detection, weighing scales, etc.
• Implantable devices – pacemakers and brain pressure sensors
• Ingestibles – core temperature sensors and medication tags

Many traditional PRO data consolidation and analysis methods require patients to complete sometimes lengthy or complex questionnaires or attend frequent appointments, which can introduce non-compliance in subjects. However, wearable devices can potentially augment the quality of data collected without introducing a limiting burden by integrating into patients’ daily routines, resulting in enhanced patient engagement and retention.

The Future of eCOA Wearables in Clinical Trials

1. Consumer- vs. Industrial-Grade Devices

A critical consideration when choosing these devices is assessing if they are fit for the intended purpose. Industrial-grade devices are specifically designed for use in clinical research, receiving CE validation and stamped for consistency. These offer higher accuracy and reliability compared to consumer-grade devices, which are designed for general use and may have wider tolerances. Algorithms are used to reduce background noise in both types of devices, but industrial-grade devices are more likely to provide consistent and reliable data. Therefore, it is important to carefully consider the purpose and requirements of the study when choosing between industrial-grade and consumer-grade eCOA devices.

Additionally, while eCOA can provide and store extensive datasets, the true value of these datasets hinges on the ability to extract relevant and actionable information. Wearables facilitate the capture of real-time, objective, and, most importantly, usable data, providing a more comprehensive assessment of a patient’s condition. This enables researchers to parse and interpret the most critical pieces of information in a broader dataset, resulting in more informed decision-making.

2. Improved Patient Compliance

There are often concerns expressed regarding patient adherence to and compliance with wearable requirements, such as forgetting to wear devices or incorrectly reporting data, which impacts the reliability of the collected data. To reduce this risk, future collaborations between device manufacturers and clinicians can identify and bridge gaps to design eCOA wearables with the patient in mind. This may involve citing previous patient experiences and modifying the technology accordingly or identifying where user-friendliness/intuitiveness can be enhanced. Techniques may involve using gamification to improve and encourage adherence and more accurate reporting. 

3. Integration with Healthcare Systems

There are numerous technological and logistical challenges associated with effectively integrating eCOA data with existing healthcare frameworks. For example, rapidly evolving technology in the wearable device space may require increased investment and staff training programs from healthcare providers to support new software. 

Collaboration between manufacturers and providers can help to assess existing technological capabilities and mitigate compatibility issues to ensure seamless integration with eCOA systems. With robust training programs, data collection, management SOPs, and a 24/7 support service, healthcare teams may face fewer complexities when operating with future eCOA/existing healthcare technological ecosystems. 

Conclusion

eCOA wearables offer significant advantages over traditional COA data collection methods and have transformed clinical trial data collection. As of 2018, the FDA has approved a number of wearable devices for use in clinical trials, indicating recognition of their utility in capturing meaningful data points, with the requirement of ensuring these devices measure changes in patient disposition. 

With the rapid evolution of eCOA modalities, additional challenges include ensuring devices are fit for clinical purposes, patient compliance, and integration with enterprise systems. Future landscapes indicate that collaboration between manufacturers, providers, and researchers can best bridge the gaps in existing processes and maximize the potential of eCOA wearables in clinical research. 

Want to learn more about optimizing your eCOA data collection and analysis? Reach out to us. 

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world experience. In this recap of the Boston session, we will review key points from each session. 

Session 1: COA/eCOA Innovations – Licensing Hiccups, Linguistic Validation, ePRO Migration, and Best Practices to Ensure First-Patient-In 
 

Key Takeaways: 

• The importance of paper backups: Despite the prevalence of electronic systems for patient data capture, paper backups are still necessary for continuity in case of technological failures or compliance with copyright holders' requirements. 

• Operational challenges of incorporating paper backups: Integrating paper backups into electronic systems presents challenges, including resistance to transitioning fully to electronic processes and the complexities of reconciling data from different sources, requiring meticulous attention to avoid discrepancies and data loss. 

• Unique challenges in rare disease studies: Rare disease studies face additional difficulties in gathering patient data due to factors such as small and dispersed patient populations, language barriers, licensing constraints, and reliance on parents and caregivers for compliance. Ensuring patient adherence to protocols is crucial, and a hybrid approach combining paper backups and electronic systems can encourage compliance and meaningful data while balancing data security concerns. 

In the rapidly advancing digital age, electronic systems and modalities for patient data capture have become the norm, offering convenience and efficiency across various industries, including healthcare and research. Perhaps more importantly, it has given us more accurate, usable patient data. However, many cases still require a paper backup. In this session, we explored the continual relevance of paper backups, their associated challenges, and the potential for hybrid models.  

While electronic modalities are demonstrably more efficient and accurate, certain circumstances, such as a catastrophic technological failure, can render these systems inaccessible, making a paper backup crucial for continuity. Furthermore, some copyright holders still rely on paper documentation, necessitating a paper trail for compliance. 

However, incorporating paper backups into electronic systems presents operational challenges, including the reluctance to fully transition from paper to electronic processes. Local disasters or device malfunctions can also render electronic devices unusable, necessitating a paper backup. Reconciling and aligning data from different sources becomes complex and time-consuming, requiring meticulous attention to avoid discrepancies and data loss. 

Furthermore, obtaining electronic instrument and systems licenses can delay timelines and present additional operational challenges. Factors such as high demand or limited availability of licenses can compound these issues and cause further delays. Regulatory requirements, such as translation licensing and study changes, can create unexpected bottlenecks. This is especially true in the case of international rare disease studies, particularly when new patients enter the study from different regions. 

As a result, rare disease studies face unique challenges in gathering patient data. The small and dispersed patient population, language barriers, licensing constraints, and reliance on parents and caregivers for compliance further complicate the process. Ensuring patient adherence to protocols is crucial for collecting meaningful outcomes and demonstrating the value of research to the rare disease community. This is compounded by the challenge of enrolling such a small patient cohort; the patient data is more valuable in some ways. 

Therefore, incorporating a hybrid approach of both paper backups and electronic systems is perhaps necessary for driving patient adherence. This approach accommodates patients who prefer paper backups or lack access to personal devices, and it encourages compliance and meaningful data. Hybrid models can also mitigate data security concerns by implementing biometric authentication on personal devices, thereby balancing patient convenience and data integrity. 

Nonetheless, stakeholders must address licensing, translation, instrument change, and regulatory compliance challenges. Collaboration, streamlined processes, and ample lead time can make a significant difference. Proactivity in the planning phase is critical for translation and licensing. Initiating the licensing process early and finalizing custom-built instruments before selecting a vendor or during feasibility stages remove potential bottlenecks and facilitate progress. 

Collaboration from all stakeholders is also essential. Involving supporting vendors, translation teams, and localization experts during protocol development establishes a framework for more effective communication. Sponsors and study teams should remain aligned on instrument changes with a mutual understanding of the risks associated with design alterations. By bringing together all key stakeholders early in the process and fostering a collaborative environment, study teams can address and mitigate challenges more effectively. It was universally agreed that engaging all stakeholders, both internal and vendor partners, early in the planning process significantly increases first-patient-in (FPI) goals.  

Session 2: Patient Recruitment and Inclusivity – Engagement Strategies for Diversity and Accessibility 

 Key Takeaways: 
 

• Importance of patient engagement: Patient engagement plays a crucial role in the success of clinical trials even before they begin. Understanding patients' lived experiences helps determine reasonable protocol criteria and assessment schedules, and tailoring communication strategies effectively enhances participation. 

• Bridging gaps for inclusivity: Acknowledging diverse cultural and socioeconomic backgrounds allows study teams to identify and bridge gaps in access, language barriers, and scheduling challenges faced by underrepresented populations. Inclusivity generates a more accurate portrayal of drug efficacy and ensures equitable access to treatment. 

• Technology and patient engagement: Mindful algorithm development, targeted simulations, and designing technology platforms with inclusivity in mind can bridge digital disparities and improve engagement. Recognizing individual preferences and providing flexible compensation models empower patients and promote long-term engagement and retention. 

 Patient engagement impacts clinical trial success before a clinical trial even begins. Study teams must understand and appreciate patients’ lived experiences to determine if protocol inclusion/exclusion criteria and visit assessment schedules are reasonable.  

Understanding patients' backgrounds allows researchers to tailor their communication strategies effectively. For example, commonly used terms, such as “investigator,” “trial,” and “consent,” may carry negative legalistic associations, making patients less likely to participate. Acknowledging diverse cultural and socioeconomic backgrounds provides a more holistic assessment of the challenges faced across different communities. From this understanding, study teams can identify where these gaps can be bridged to maintain engagement.  

Challenges may include a lack of access to certain technologies, language/accessibility barriers, or navigating site visits around work/family schedules. While driving inclusivity may command additional resources to accommodate specific patient needs, engaging diverse demographics generates a more accurate portrayal of drug efficacy. Therefore, in the interest of a comprehensive public health model and equitable access to treatment, underrepresented groups must receive proper representation throughout a clinical trial.  

Technology can potentially enhance the recruitment, retention, and engagement of underrepresented populations. However, it is essential to be mindful of the digital divide, ensuring equitable access and providing necessary resources and support to afford patients equal opportunities. Furthermore, leveraging technology and digital innovation should be balanced by mindful algorithm development and targeted simulations to reduce bias and improve inclusivity. Designing technology platforms with patient inclusivity in mind and utilizing familiar channels can help to bridge digital disparities and enhance engagement. 

In addition to ensuring equitable access to digital tools, recognizing individual preferences, motivations, and compensation options empowers patients and promotes long-term engagement and retention. Flexible compensation models and incentives allow participants to choose rewards that resonate with them. 

Regulatory guidance, such as the FDA's focus on diversity in clinical trials, encourages industry stakeholders to prioritize inclusivity. Pre-engagement strategies, comprehensive patient selection, and addressing broader healthcare and wellness issues contribute to building trust and achieving meaningful results. Continued progress requires accountability, tangible actions, and prioritizing diversity in all aspects of healthcare. 

Section 3: Remote Study Team Engagement – Patient Safety, Site Accountability, and Clinical Document Quality 
 

Key Takeaways: 

• COVID-19 impact: Limited resources and staff shortages have slowed clinical trial progress while innovations have emerged to engage patients and minimize infection risks. 

• Expanded reach and decentralization: new sites in diverse regions mitigate resource constraints, and feasibility studies determine opportunities for remote options and best practices sharing. 

• Proactive engagement and technology integration: Sponsors should support sites, provide incentives, and connect with recruitment agencies to drive engagement early in the process. Technology, including virtual communities and wearables, enhances patient engagement and real-time data collection while facilitating effective communication among study team members. Maintaining trial integrity is vital, balancing accessibility with data quality and patient safety. 

In recent years, the impact of the COVID-19 pandemic on various stages of clinical research has become apparent. Limited resources at clinical trial sites have resulted in slower site response times and engagement. Additionally, a shortage of qualified individuals, including sponsors and contract research organizations (CROs), has further hindered trial progress. The vacancies left from staff changes were slow to be filled, leading to increased contract review timelines and reduced recruitment momentum. Challenges were also associated with having patients present at trial sites, with many avoiding healthcare facilities entirely in an effort to reduce exposure. However, these challenges bred innovations to facilitate ongoing and future trials with minimal interruption, with researchers identifying new ways to ensure they can engage patients while also minimizing the risk of infection.  

The introduction of new sites in different regions during the past few years has also expanded the reach of clinical trials and mitigates resource constraints. Engaging with sites in diverse countries and conducting regional investigator meetings ensures culturally appropriate messaging and facilitates the sharing of best practices. Feasibility studies play a crucial role in determining- 

One critical takeaway is the importance of proactive engagement with clinical trial sites. Sponsors should understand the needs of different sites and offer support to strengthen the sponsor-site relationship and alleviate the burden on trial site personnel. In terms of resource building, sponsors may introduce incentives, such as sponsoring conference attendance for study coordinators, subsidizing continuing education for site personnel, and providing grants for necessary equipment. These measures address specific site needs and create a sense of reward and appreciation for their contributions. Connecting sites with recruitment agencies can also help alleviate remaining staffing challenges. Facilitating introductions between various agencies and sites allows for the identification of suitable local talent, easing the strain on site personnel. 

Throughout the transition to remote trials, technology has been a cornerstone in ensuring smooth, ongoing operations. It has provided flexibility for clinical trial participants to communicate with healthcare professionals without in-person visits, reducing travel burdens and potential exposure. Technological advancements, including virtual patient communities, wearable devices, and mobile applications, enhance patient engagement, enable real-time data collection, and facilitate remote monitoring. Leveraging collaborative project management tools, virtual meetings, and webinars enables effective communication, knowledge sharing, and collaboration among study team members, regardless of their physical location. As we continue to move into a decentralized clinical landscape, we will continue to see innovations simplifying processes for both patients and research staff alike. Furthermore, there is the expectation that regulatory authorities will begin providing more refined guidance on leveraging clinical technologies and data capture/security.  

While decentralized clinical trials (DCT) have the potential to make trials more accessible and patient-centric, maintaining trial integrity is crucial. Recent FDA guidance on DCTs emphasizes the importance of balancing accessibility with data quality and patient safety. Active engagement with sites, tailored support, streamlined processes, and technology integration enhance remote study team engagement. Building strong relationships between sponsors and sites ensures efficient clinical trials, advanced medical research, and improved patient care. 

Session 4: EU Clinical Trial Regulation – Operational Considerations and Impacts 

Key Takeaways: 

• EU Clinical Trial Regulation (EU CTR): Organizations conducting trials in the EU need to understand the new regulatory framework, transition from the previous regimen, and comply with new requirements. This includes updating quality management systems, understanding the EU portal, and ensuring streamlined submissions and translations. 

•  Operational challenges with the EU portal: While the EU portal streamlines the application process, it may not fully address all user requirements, and managing multiple studies within the portal can be complex. Researchers should anticipate increased workloads and consider optimization strategies to expedite the handling of queries. 

• Compliance and transparency requirements: The EU CTR emphasizes transparency and disclosure of trial information. Responding to queries within tight timelines requires a thorough assessment of translation processes, removal of confidential/personal data, and adherence to transparency requirements. 

The field of clinical trial management witnessed a significant development with the introduction EU CTR. This regulation impacts various aspects of clinical trial management activities. Understanding the new regulatory framework and complying with requirements become crucial for organizations intending to conduct trials within the EU. When a trial is authorized under the previous regimen (CT Directive) and continues in Europe after January 2025, researchers will need to transition to the new regulatory framework. The transition requires submission via the new EU portal and may involve updating protocol or other study documents to ensure overall compliance with the new requirements. In all, the new regulation brings forth a litany of operational considerations, including updating your quality management system, understanding the EU portal, handling sensitive data (transparency/disclosure), and ensuring streamlined submissions and translation processes across the board.  

Operational Considerations 

One of the primary factors in rolling out the EU CTR was the development of the EU portal, a technical platform for submitting clinical trial applications. This enables researchers to complete a single application that is distributed to the relevant countries for assessment. This centralized submission process streamlines the application process but also introduces dependencies between countries' submissions. It is crucial to have all documents ready simultaneously to ensure timely initiation across all countries. 

Despite a feeling of positive progress surrounding the EU portal, it has also brought operational challenges. The portal was initially released as a minimally viable product, and its functionalities may not fully address all user requirements. Additionally, managing multiple studies and administrative processes within the portal can be complex, and extracting information for higher-level master files may require additional effort. Therefore, it is essential to be prepared for the potential of increased workloads and consider optimization strategies, such as centralization or expedited handling of queries. 

In relation to compliance activities, there is a legal requirement to respond to queries from ethics committees and regulatory authorities within 12 calendar days, leaving limited space for negotiation. Promptly answering queries necessitates document amendment, language translation, eventual redaction of confidential/personal data, and submission preparation, all within tight turnaround times. Therefore, research teams should thoroughly assess the readiness of translation processes and their articulation with redaction activities and ensure comprehensive approval processes to meet these requirements. 

One key component of the regulation is transparency, as it emphasizes the disclosure of trial information to foster clinical research and enables patients to access relevant trial information and statistics. This means many of the documents submitted through the portal will be made public after a certain period. This may prompt changes to how researchers handle sensitive data, in that they should be meticulous in the removal or redaction of confidential/personal data from submissions before they are presented.  

In cases where additional countries must be added to a trial following initial submission, the process will depend on whether the countries were already selected for participation in the trial (but not ready at the time of submission) or if they are new additions. If the countries are already part of the trial, you will need to complement your initial application with country-specific information to reach an initial decision for that country (with a review process to apply for the new country information). For newly added countries, you will need to submit an additional member state application to the existing submission. This application will go through a slightly different review process than the initial application, focused on the newly added country’s/countries’ information.  

The Future of EU CTR 

Despite intentions to streamline the clinical trial submission process, challenges have been and continue to be observed in the rollout of the new regulation in day-to-day operations. There have been numerous technical issues flagged with the new systems, and the lack of predictability creates uncertainties and potential delays. The European Medicines Agency (EMA) acknowledges these issues and plans to address them through ongoing development and optimization of the CTIS portal.  

The European clinical trial submission process is still in its early stages, and further refinements are expected. Initiatives like the Act2 project aim to make Europe more attractive on political and regulatory levels. However, changes to the process and regulations will take time to fully implement. To that end, it is critical that stakeholders continue to engage in discussions, provide feedback, and contribute to shaping the future of the European clinical trial landscape through optimization and streamlined operations.  

Under the EU CTR, stakeholders are being challenged with adapting to new procedures and technical requirements while carefully planning their submissions. Early inclusion of countries, active engagement with the EU portal, and compliance with timelines and transparency requirements are instrumental in ensuring successful submissions. As the system evolves and technologies are further refined for usability, the projection is that the European clinical trial landscape will become more efficient, transparent, and attractive for sponsors and researchers alike. 

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The C3 Summit focuses on relevant topics in the clinical space, including patient recruitment and leveraging AI in clinical technologies. Upcoming sessions include a focus on EU CTR, patient diversity, and eCOA. Interested in attending upcoming C3 Summit sessions in a city near you? Register today for our upcoming London or Princeton events to secure your spot to access exclusive expert insights and connect with industry peers. 

Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and understands their treatment regimen, medical resources, and clinical trial options.  

Studies show that patients who are engaged in their healthcare demonstrate higher levels of adherence to treatment, achieve improved health outcomes, and are all-around more satisfied with their care. As part of a well-rounded patient engagement strategy, ensuring high-quality medical writing should be prioritized. Consider the following items to produce more patient-centered content. 

Write for Patients 

Patient-centric writing focuses on the specific needs, preferences, and values of patients. Patient-centric medical writing considers the patient’s level of health literacy, cultural background, and personal beliefs. For example, when creating informed consent forms, patient centricity is a key factor in determining how well a patient can comprehend and make informed decisions based on the content.  

Patient-centric medical writing also accounts for providing details that are relevant and meaningful to the end user. For example, when developing patient education materials, medical writers can tailor content to a specific condition, stage of the disease, and treatment plan based on the patient population and patient feedback. This level of personalization can yield increased patient engagement and, subsequently, promote patient self-management.  

Develop Interactive Content  

In the development of interactive and multimedia content, such as videos, animations, infographics, quizzes, and eLearning, medical writers can pull in elements of personalization to make materials more engaging and compelling.  

These types of content help to educate patients about their conditions, provide information about treatment options, and empower patients to take an active role in their care plan. Examples of interactive content may include: 

• An interactive quiz used to help patients understand the signs and symptoms of a mental health condition  
• An animation shared across social media to bring attention to an oncology clinical trial enrolling in a specific region 
• An educational video teaching patients and caregivers about available treatments for a chronic illness 

Medical writers can incorporate interactivity early in the development process to ensure these materials are not simply comprehensive but also engaging and interesting to patients. 

Prioritize Patient Access 

Medical writing activities should prioritize patient access and consider various factors, such as communication preferences (digital versus paper), accessibility, and linguistic availability through translation and localization. Understanding how patients engage with content and selecting the appropriate medium based on patient preference and technological accessibility empowers patients to make informed healthcare decisions. 

To ensure inclusivity, medical writers should also consider the needs of disabled populations, including individuals with vision impairment, hearing disabilities, and other physical or cognitive impairments. This includes providing alternate formats, such as braille, auto-speech recognition, and closed captioning, to enhance accessibility. It is important for medical writers to assess and identify opportunities for improved accessibility options, particularly for patient-facing content. 

Additionally, a patient's cultural background significantly influences their engagement with medical communications. Translation and localization play a vital role in ensuring equitable access for patients who may have difficulty engaging with the dominant language of the healthcare system. Offering multilingual materials demonstrates respect for patients' cultural and linguistic backgrounds and facilitates comprehension of complex medical concepts. Removing linguistic and cultural barriers in medical writing practices is an essential component of an effective patient engagement strategy.  

Assess Medical Content 

To validate that patient materials can reach intended audiences, medical writing content should be evaluated for readability, relevancy, and applicability. To do so, patient materials should be assessed via readability metrics, such as Flesch Reading Ease or Flesch-Kincaid Grade Level. Medical writers may also consider the use of artificial intelligence and machine learning to assess readability on a deeper level.   

To optimize patient engagement, direct patient review of patient materials can also be integrated into the content development workflow. Any number of engagements can be considered, including patient focus groups, written reviews, interviews, surveys, workshops, and advisory boards. Patient feedback can be gathered during such engagements and implemented into the content to better incorporate the patient’s voice.  

Conclusion 

Effective medical writing is instrumental in establishing clear lines of communication between patients and providers. Adopting a patient-centric writing strategy means medical writers can help patients better understand their healthcare options and empower them to take an active role in their care. As such, medical writing should be viewed as an integral component of patient care, with the potential to make a significant impact on the lives of patients and their families. 

Want to ensure your medical writing activities are prioritizing patient engagement? Reach out to us today to discover how TransPerfect Life Sciences’ Medical Writing Solutions can help build your effective medical writing strategy.