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.
Solutions
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Resources
- Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization
- Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success
- Master Protocol Value Proposition Guide
- Master Protocols Operations Partner Assessment
- Statistical Simulation in Master Protocols: Components & Communications Considerations
- Master Protocol FDA Engagement Tool
- Master Protocol Content Development Guide
- STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate Cancer
- Case Study: Using Central Labs in Master Protocol Trials
- Master Protocol References & Resources
Related Items
- Mobilizing the Clinical Trial Ecosystem to Drive Adoption of Master Protocols
- The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies
- New Resources for Designing and Running Master Protocols
- New Resources for Designing and Running Master Protocols Webinar Slides
- Master Protocol 2020 Expert Meeting
- Master Protocol 2019 Expert Meeting
News
- New CTTI Publication Investigates Best Practices for Driving Adoption of Master ProtocolsIn a new publication, CTTI applies expertise from industry sponsors, regulatory agencies, patient groups, and academic institutions to identify best practices for driving the widespread adoption of master protocols. Master ...