Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
RAPS

FDA Officials: Master Protocols Needed for Precision Medicine

In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple ...
FiercePharma

How J&J Innovative Medicine Applies Innovative Trial Designs for Patient Flexibility and Efficient Drug Development

Why do you believe master protocols are so important to the future of clinical research? A master protocol approach can provide inferential benefits and operational efficiency. Clinical development is ...
JD Supra

Master(ing) Protocols for Randomized Umbrella and Platform Trials

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
ascopubs.org

Master Protocol Design With Hybrid Control for Efficient Early-Phase Trial Consolidation

Timing of Adjuvant Chemotherapy After Gastrectomy in Patients With Stage II to III Gastric Cancer: A Target Trial Emulation Study Master protocols represent transformations, enabling multiple ...
EurekAlert!

Lung-MAP master protocol model broadens trial access for some underrepresented groups

As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of ...