C-Suite: Clinical Trial Design & Decision Making

Traditional pharmaceutical decision making is executed within a framework of an individual clinical trial. Much less consideration is given to the value of decisions in the context of development programs or portfolios. This presentation will make the case for decision making in a broader context. Methods for maximizing the value of programs and portfolios will be described. The presentation will be concluded with illustration of frameworks necessary for implementation of decisions at a higher level.

Learn how to:

• Drive commercial success by improving probability of success in Phase 3 through refined Phase 2 designs.
• Use program and portfolio optimization to facilitate improvements on master protocols and related designs.
• Make strategic use of opportunities presented by uncertainty by optimizing a quantitative decision-framework at the program-level.
• Take advantage of Bayesian methods when designing every Phase of a trial as well as in informing intra-trial decisions.

Zoran Antonijevic is Head of Biometrics at MedSource. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Adaptive Design Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and “Platform Trials in Drug Development”.