Recognizing that multi-regional clinical trials (MRCTs) are essential to oncology drug development, the Reagan-Udall Foundation for the FDA (Foundation) convened an expert roundtable to examine ways to improve trial clarity, consistency, and efficiency with a focus on what trial sponsors (biopharmaceutical companies and CROs), clinical trial sites, FDA and global regulators, and patient advocates might realistically address.
The resulting report, “Improving Oncology Multi-Regional Clinical Trials” presents short-, mid-, and long-term solutions to barriers such as lengthy site activation timelines, slow patient enrollment, regional variability, and misalignment in standards of care.
The report is divided into two main sections: the first addressing activation, enrollment, and study start up timelines and the second addressing science-based approaches to clinical trial representativeness targets and generalizability analyses. Each section discusses challenges, relevant efforts and activities, and recommendations to advance prioritized solutions. A complete list of these recommendations, with identified stakeholders, and estimated time frames are provided in Appendix A and Appendix B. The intent of this project is to serve as a platform to stimulate focused activities on the recommendations.
