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Industry Event

DIA Master Protocols Workshop

The urgency to speed access to innovative therapies and vaccines has never been so evident as during the COVID-19 pandemic. With literally hundreds of potential medicines candidates under investigation, the ability to work efficiently and productively relies on open collaboration within frameworks that can answer multiple clinical questions in one overall trial structure. Master Protocols (MAPs) provide such frameworks and represent a paradigm shift in therapeutic research through an ongoing opportunity to more efficiently address a broader set of objectives than would be possible in a series of independent trials.

The concepts of Master Protocol trials have matured since the first oncology basket trials almost 20 years ago, and today we recognize multiple design types, such as adaptive platform and umbrella trials, for studying a wide array of indications. Examples include DIAN-TU (Alzheimer’s Disease), REMAP-CAP (Community-Acquired Pneumonia), HEALY ALS (Amyotrophic lateral sclerosis), PrecISE (Asthma), and ACCORD (COVID-19), among others. As Master Protocols evolve and become more mainstream, they are presenting continual design, implementation, and operational learnings that can be built upon as the drug development paradigm shifts to one of collaboration and sharing.

Now in its third year, DIA’s Master Protocol Workshop focuses on design, planning, implementation, start-up, and evolving operational best practices through the lens of Master Protocol trial stakeholders. Join industry, patient, regulatory agency, other government, and NGO representatives to examine the growing body of knowledge, experience, and resources available to better meet patient needs through successful Master Protocol trials.

TransCelerate’s Executive Vice President Janice Chang will be presenting “COVID-19 Learnings: Research Done Differently.”