Scientific and Operational Guidelines for Conduct of Embedded Interviews With Participants in Clinical Trials

The United States’ Food and Drug Administration’s patient-focused drug development guidance series demonstrates an increase in attention paid to using qualitative methods to collect patient experience data. A recent literature review (Michel, Kamudoni et al., 2023) indicates that conducting interviews with participants in clinical trials, often called in-trial interviews, yields valuable evidence for scientific communications, regulatory approvals, and health technology assessments. As more in-trial interviews are conducted, harmonized guidelines for the healthcare industry are needed. With 10 years of experience managing such interviews, we propose here an overview of scientific and operational steps to consider when doing such a study.

From a scientific perspective, best practices when conducting qualitative research in health psychology should be followed: clearly defined objectives and protocol, specified population of interest and adapted interview guide, trained interviewers, continuous monitoring of interview conduct, and rigorous analysis and reporting processes. Timing of interviews and sharing of transcripts should respect trial integrity and impacts on other trial data should be minimized. Furthermore, involving patients/caregivers and sites in the development of the interview guide, protocol, analysis, and dissemination will ensure that interviews are a patient-centered trial procedure.

From an operational perspective, the first step is to verify with ethics committees and data protection agencies the conditions needed to conduct interviews. Each site and each country may have different requirements. Second, procedures must be outlined to guarantee participant confidentiality of interview data and safety reporting of any adverse events. Third, sites must be trained on their responsibilities and monitored. Last, an accountability matrix illustrating the roles of all parties (CRO, sponsor, sites, interviewers) and frequent clear communications are needed.

When such scientific and operational guidelines are respected, the foundation is laid for the successful collection and analysis of valuable patient-centered evidence of treatment, disease, and trial experience.