NEW Workshop!

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (MAPs), including basket, umbrella, and platform trials, provide a method to answer multiple questions in one overall trial structure. Although MAPs require increased planning efforts and coordination, they provide an opportunity to efficiently address a broader set of objectives than would be possible in an independent trial. DIA’s new Master Protocol Workshop will examine the common features and the advantages and limitations of different types of MAPs, along with lessons learned from recent master protocol clinical trials such as LUNG-MAP, I-SPY 2, EPAD, DIAN-TU, and others. Experts will discuss best practices for master protocol study design, collaboration - including navigating public-private partnerships and international considerations, and operationalization.

Highlights

• An in-depth look at ISPY2 and EPAD
• Discussions on various design features within a platform trial including randomization, blinding, treatment comparisons, and more
• Explore best practices for operationalizing master protocols and how master protocols impact internal stakeholders’ processes
• Networking Reception at the conclusion of day one to continue the conversation and make connections

Additional Resources

• TIRS Article: Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols
• TIRS Article: The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials