Leveraging Interim Analyses to Optimize Late Phase Clinical Trial Decision Making

Interim analyses (IA) are an essential part of clinical trials that—as a form of adaptive design—can help sponsors make informed decisions about whether to keep a trial going or discontinue it entirely. But for many sponsors, the complexity of IAs can prevent organizations from keeping their trials well-controlled and developed to their full potential. Between efficacy and futility stops, as well as other evaluations such as variance checks or sample size reassessments, the landscape surrounding IAs is comprehensive, fast-changing, and highly nuanced.

Those barriers shouldn’t stop sponsors from embracing…well, stops—or any other IA type, either. Drug developers of any size can glean the many benefits of IAs, from better and richer data that answers the research question to a potentially more favorable regulator response. How, though? Well, ask the experts. Join Rho’s Brett Gordon, Ben Vaughn, and Scott Mollan for this Q&A roundtable that will cover some of the most frequently asked questions they get from pharma companies about interim analysis. You’ll learn:

  • What the different types of IAs are as well as the risks and benefits of each
  • Key statistical and design considerations as well as operational expectations of IAs
  • Case studies that demonstrate the potential applications of different IA options Best practices when presenting IA data to the FDA

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