Operationalizing Master Protocols Encore Presentation

On-Demand Webinar

Session #304 from 2019 Global Annual Meeting Plus Live Q&A

In this webinar...

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more intentional planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.

Featured Topics:

  • Master Protocols; Design and Execution Considerations
  • Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, such as Platform Trials
  • Statistical Analysis Opportunities and Challenges with Master Protocols

Learning Objectives

At the conclusion of this webinar, participants should be able to:

  • Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket, and platform)
  • Describe considerations and challenges for master protocol development
  • Discuss a case example for using the common protocol template basket studies
  • Identify critical elements around data collection, analysis, and interpretation

Presenters

  • Meredith Buxton, PhD, MPH
  • Mitzi Allred, PhD
  • Karen Lynn Price, PhD, MA