Master Protocol Studies

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OVERVIEW

The value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges.

Working with stakeholders across the clinical trials ecosystem, CTTI developed a robust set of resources - including a Master Protocol Design & Implementation Guide, Value Proposition Guide, and FDA Engagement Tool - that guide the appropriate use of master protocols.

Additionally, specific to the pandemic, CTTI led a panel discussion, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, highlighting results from an analysis of data from ClinicalTrials.gov, as well as best practices and insights from those involved in COVID-19 treatment master protocols.

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