AIMS: Inclusion of interviews conducted with study participants within clinical trials is an evolving field of research. Interview data collected from patients (or caregivers) may support value messaging for products (approved or investigational), as they can supplement, support, and facilitate the interpretation of study endpoint data collected via standard COA measures and clinical indices. However, one size does not fit all for in-trial interviews. The aim of this presentation is to discuss factors critical to consider in selecting the appropriate research question(s), design, and methodology to address the Sponsor’s objectives for, and intended uses of, the interview data; and potential challenges to data collection at the outset.
METHODS: This session will describe various methodological approaches that can be employed in conducting in-trial interviews, including those focusing on purely qualitative, strictly quantitative, or mixed-methods approaches.
RESULTS: The pros/cons of each approach will be presented in relation to the anticipated use of the data by the Sponsor. Additionally, the session will present key methodological and operational issues that should be considered to maximize success in data collection and the quality of interview data. Specifically, these will include in-trial interview design issues such as the optimum timing during the clinical trial design process to plan for in-trial interviews, the context of interviews within the clinical trial (i.e., pros and cons of conducting merged versus independent sub-study designs), when to consider in-trial versus exit (end of trial) interviews, optimizing interview content to meet research objectives, the importance of considering interview population-specific challenges (e.g., rare diseases, trial populations focusing on children or cognitively impaired respondents), consideration of respondent burden, who will conduct the interviews (and where), and the specific challenges associated with conducting interviews across multiple countries/languages.
CONCLUSION: The presentation will be supported by real and hypothetical examples of success and challenges in in-trial interview studies. Following this session, attendees should have a good understanding of key considerations (i.e., critical questions, timelines, budget and operational support) needed to successfully plan for commissioning or implementing in-trial interviews.
