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Master Protocols: Innovative Trial Designs and Keys to Operational Success

Using experience in COVID-19 and oncology, members of PPD’s Master Protocol Working Group discuss the benefits of master protocols, particularly in umbrella and platform trials, as well as the common obstacles in implementing these designs. To help developers considering this approach, they outline five operational guidelines for success in their Applied Clinical Trials’ article, How to Address—and Overcome—Operational Challenges in Master Protocol Studies.” Download the article below.

While the scientific and operational challenges of clinical trials that use master protocols are real, our experiences have shown again and again that the efficiencies and benefits far outweigh the complexities.

Dirk Reitsma, M.D.
Senior Vice President, Oncology, Global Product Development