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

ABSTRACT:

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 repres

SUBMITTER: van Hattem CC 

PROVIDER: S-EPMC11552028 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature