Master Protocol Workshop

This year’s Master Protocol Workshop focuses on Adaptive Platform Trials (APTs), powerful trials that study multiple therapies with multiple patient populations at once. Join industry, patient, regulatory agency, and other government experts to explore funding and start-up considerations, regulatory engagement, and key operational concerns through the lens of four different APT implementation models. A panel of global regulators will share their perspectives on the implementation of these trials in their regions, application to a wide range of therapeutic areas beyond oncology, and progress toward global regulatory alignment.

Need approval in order to attend?

Check out our 2019 Program!

Professionals involved in:

• Biostatistics, including Adaptive Design and Bayesian Statistics
• Clinical Research
• Research and Development
• Trial Design
• Clinical Operations
• Therapeutic Area Development, Management, and Operationist
• Rare disease, oncology, immunology, Alzheimer’s disease
• Medical Affairs
• Medical Science Liaisons
• Medical Writing
• Regulatory Affairs

• Describe value drivers behind adaptive platform trials for key stakeholders (patient organizations, research sponsors, public institutions, regulatory agencies, and others) including how they may benefit and contribute to trial start up
• Discuss how stakeholder groups have successfully organized and started platform trials within common models of collaboration (patient organization driven, single company sponsor, multiple company sponsor, and government/public institution driven), addressing key elements such as funding, governance, and regulatory engagement paths
• Summarize regional regulatory perspectives on adaptive platform trials and current progress toward global alignment
• Discuss emerging best practices for key operational components that are critical success factors for platform trials, such as data sharing and network building