✅ Factors affecting the feasibility of post-authorisation RCTs for conditionally authorised anticancer medicines: a multistakeholder perspective from a qualitative focus group study

Science

Objective The collection of comprehensive data from post-authorisation trials for conditionally authorised anticancer medicines is frequently delayed. This raises questions about the feasibility of post-authorisation randomised controlled trials (RCTs) that aim to address remaining uncertainties. Therefore, this study explored factors that facilitate or impede the feasibility of post-authorisation RCTs from the perspective of stakeholders directly involved in the design, medical-ethical approval, and conduct of these RCTs. Design We conducted four qualitative focus groups (FGs). Setting FG discussions focused on the oncology setting in European context. Participants Twenty-eight European patients, physicians, medical ethicists and pharmaceutical industry representatives participated in the FGs.

BMJ     Nov 09, 2024