Walking the Tightrope: Navigating Patient Centricity and Burden in Modern 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.