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:
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.
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.
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.
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.
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.
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.
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.
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.