Conducting trial participant interviews in the context of clinical trials, also known as embedded/ exit interview (EEI) studies is a research paradigm that can provide a variety of benefits, including understanding the patient perspective about treatment benefit, treatment burden, safety/tolerability of treatments to inform risk/benefit analysis. Results from EEI studies can enhance the interpretation of clinical trial data, confirm patient relevance of treatment outcomes and meaningfulness of clinical benefit. Over the last few years, there has been a growing interest in EEI studies mainly driven by the US regulators recommending EEI as a research methodology to gather patient input and determine what is a meaningful clinical benefit. During drug development, these data are increasingly valued by regulatory bodies to enhance understanding of treatment outcomes and inform regulatory decision making.

While this type of research is now often used within the clinical trial context, they do pose unique operational and logistical challenges requiring careful planning and preparation. This presentation will provide insights on benefits of EEI for regulatory decision-making and provide opportunities to learn about methodological approaches for collecting and analyzing qualitative data in clinical trials.

Seating is limited.

Sponsor: Evidera