Understanding patient experiences in clinical trials: Should exit interviews be considered essential?
Drug development refers to the process of bringing a new medicine to market to improve patients’ lives—but how often do we ask patients themselves about their overall treatment experiences? While exit interviews are becoming more common, they remain far from a universal standard in clinical practice.
What are exit interviews, and what do they aim to achieve?
Exit interviews involve in-depth discussions with patients—and sometimes their caregivers—to gather qualitative feedback about their treatment experiences, perceptions of efficacy, and overall quality of life in clinical trials. (1)
As patient-centred research and regulatory decision-making gain prominence in the healthcare industry, exit interviews can empower patients and shape the drug development lifecycle to align with their true needs and preferences. Exit interviews advance patient-centric research by: (2,3)
Capturing patients’ perspectives on their treatment journeys, assessing whether changes in their disease experience are meaningful
Identifying the safety profile and evaluating the benefits and risks of novel interventions, providing opportunities for further advancement
Supporting the development and interpretation of patient-reported outcomes (PROs)
Informing future trial designs and endpoint selection to better address patient needs
How and when are exit interviews conducted?
Exit interviews can be ‘embedded’ within clinical trials, conducted either as a one-off or at various points throughout the trial. Alternatively, patient insights can be gathered through associated interview studies, where participants enrol in exit interviews after completing the trial. (1)
Some trials collect qualitative data through focus group discussions to foster participant interaction and gather diverse insights, while others adopt a more personal approach with one-on-one interviews. Focus group discussions typically use a discussion guide with open-ended questions, and one-on-one interviews follow a semi-structured guide with predetermined questions. Both approaches allow the researcher to shape the conversation around specific topics and probe further when necessary, ensuring qualitative feedback objectives are met. (4,5) Additionally, patient-completed questionnaires may be included to complement data collected from qualitative interviews. For example, in one study, patients who received tirzepatide for type 2 diabetes completed the EQ-5D-5L questionnaire after an exit interview to assess their overall health status. This allowed the sponsor to identify the health domains most affecting patients with type 2 diabetes, with pain/discomfort and mobility being the most commonly reported challenges. (2)
A critical aspect of the exit interview methodology is interviewer training. The interviewer must be familiar with the discussion guide to ensure the conversation flows smoothly and covers all key topics. (2) Furthermore, the relationship between the interviewer and interviewee should be considered; interviewers should always be third parties to minimise potential bias.
Although interviewers undergo thorough training, they are not responsible for collecting all the participants' feedback during the interview. Exit interviews are audio-recorded (with the participants’ informed consent) and transcribed verbatim. The researchers then code the transcriptions to categorise the data into common themes, making it easier to analyse. (2)
How can exit interviews benefit both sponsors and patients?
The rich, qualitative information collected during exit interviews can provide valuable benefits for multiple stakeholders, including sponsors and patients.
By exploring meaningful changes in patients’ disease and treatment effects extending beyond clinical indicators, sponsors can:6
Provide real-world evidence to shape regulatory submissions
Guide marketing strategies
Inform the design of future studies
Support the development and approval of publications
Refine PRO endpoints
One example of the value of exit interviews in identifying novel PRO endpoints was described by Matza and colleagues (2022). In qualitative interviews following treatment, patients with type 2 diabetes highlighted the significant emotional impact of improved glycemic control, body weight, and energy. These findings suggest that assessing the emotional impact of type 2 diabetes treatment could be a valuable PRO measure in future clinical trials. (2)
Similarly, participating in exit interviews can give patients a sense of empowerment by allowing them to contribute to research that may advance the standard of care for others and share their experiences—both positive and negative.
These multi-stakeholder benefits are especially valuable in the rare disease space due to the underrepresentation of these conditions. (6)
How can we maximise stakeholder outcomes from exit interviews?
By communicating diverse, qualitative patient experiences to patients and the broader scientific community, we can enhance transparency and foster trust across stakeholder groups to strengthen these collaborations. Broader dissemination is valuable to encourage the adoption of best practices in patient-centric trial design and demonstrate how patient feedback shapes treatment development.
At Synthesis, we leverage our medical writing expertise to amplify the power of patient voices in the clinical landscape. By developing publications that disseminate and elevate the findings of exit interviews, we aim to improve patient experiences and enhance clinical trial outcomes. Contact us at info@synthesishealth.co.uk to discover how we can help you integrate exit interviews into a comprehensive patient engagement strategy. Together, we can standardise the role of exit interviews in clinical settings and drive progress in the drug development process for all stakeholders.
References
Addressing the Challenges of Conducting Qualitative Interviews within Clinical Trials https://www.evidera.com/wp-content/uploads/2024/05/Addressing-the-Challenge-Qualitative-Interviews.pdf
Matza LS, Stewart KD, Landó LF, Patel H, Boye KS. Exit Interviews Examining the Patient Experience in Clinical Trials of Tirzepatide for Treatment of Type 2 Diabetes. Patient. 2022;15(3):367-377. doi:10.1007/s40271-022-00578-8
Michel AS, Kamudoni P, Marrel A, et al. Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review. Front Med (Lausanne). 2023;10:1197529. Published 2023 Jun 20. doi:10.3389/fmed.2023.1197529
Khalife J, Ekman B, Ammar W, et al. Exploring patient perspectives: A qualitative inquiry into healthcare perceptions, experiences and satisfaction in Lebanon. PLoS One. 2023;18(8):e0280665. Published 2023 Aug 17. doi:10.1371/journal.pone.0280665
Chladek M, Burbridge C, Gibbons E, Willgoss T, Smith J, Clinch S. Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability. Patient Relat Outcome Meas. 2023;14:313-335. Published 2023 Nov 21. doi:10.2147/PROM.S385682
DiBenedetti DB, Brown T, Romano C, et al. Conducting Patient Interviews Within a Clinical Trial Setting [Internet]. Research Triangle Park (NC): RTI Press; 2018 Aug. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542736/doi: 10.3768/rtipress.2018.op.0054.1808