OBJECTIVES: This review aimed to explore how qualitative interviews conducted within clinical trials are considered by health authorities in USA and Europe for marketing authorization and reimbursement.

METHODS: A targeted review was performed in June 2024 using keyword searches and handsearching/snowballing techniques to identify regulatory and health technology assessment (HTA) submissions mentioning in-trial/exit interviews with patients within the last 5 years (June 2019 – June 2024). A search in FDA, EMA, CADTH, HAS and NICE drug package submissions was aimed to find examples of inclusion of evidence, data, or results from interviews in product labeling. An additional search of guidelines and labeling claims of approved products regarding qualitative research was performed in various sources of grey literature. The labels were reviewed and selected if they mentioned the use of in-trial exit interviews, or more broadly qualitative methods. HTA reports were subsequently searched to check if qualitative interviews were used for reimbursement evaluation by payers.

RESULTS: Two FDA guidances were identified that recommended conducting clinical trial interviews to collect a variety of information, including exploration of meaningful change. One EMA guidance was reviewed which specifically recommended conducting exit interviews to explore patient experience and efficacy. Multiple drug package submissions included clinical trial interview data, but limited insight into how interviews were evaluated by reviewers.

CONCLUSIONS: Patients play a crucial role in regulatory and HTA submissions by providing unique insights that can improve the relevance, quality, and acceptability of health technologies, and clinical trial interviews are a valuable source of the patient voice within clinical trials. However, there is still a lack of clear guidance around the conduct and use of clinical trial interviews in regulatory and HTA submissions, especially in how they inform decisions. Despite growing interest in these types of interviews, best practices for their design, implementation, and eventual use are still evolving.