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Eliminating Underperforming Clinical Trial Designs

Much of the discussion about clinical trial design considers methods to optimize performance characteristics and de-risk trials to give high quality medicines the best chance of reaching deserving patients. An important element of this is quickly identifying and eliminating those trial designs which would underperform upon closer examination. As the number of design options rises from a few dozen to a few million, thanks to powerful new simulation and forecasting engines, being able to determine the right set of trials to focus on becomes a key strategic benefit.

This can prove challenging because every clinical trial sponsor aims to design a clinical trial with somewhat different operational and market challenges in place. For many there are strict resource limitations in terms of sample size and upfront costs. Others might have competitors positioned to capture segments of the market if a clinical trial is not accelerated. Still others might worry that due to a variety of statistical challenges, their trial design might be underpowered.

Last week I wrote about new research conducted by Cytel CSO Dr. Yannis Jemiai, which shows how to use customized Scoring Functions to quickly rank-order clinical trial designs by preferred performance characteristics. This week, another position paper co-authored by Dr. Jemiai, Professor Nitin Patel and myself highlights how familiar Pareto optimization techniques can be adapted to quickly identify the trial designs on which sponsor leadership teams should be deliberating.

The paper also advances the possibility that late phase trial designs can begin to facilitate commercial and market access strategies, by measuring and ranking designs in accordance with expected NPV.

Download paper to learn more:

Read Paper

About the Author of Blog: 

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Dr. Esha Senchaudhuri is a research and communications specialist, committed to helping scholars and scientists translate their research findings to public and private sector executives. At Cytel Esha leads content strategy and content production across the company's five business units. She received a doctorate from the London School of Economics in philosophy, and is a former early-career policy fellow of the American Academy of Arts and Sciences. She has taught medical ethics at the Harvard School of Public Health (TH Chan School), and sits on the Steering Committee of the Eastern Division of the Society for Women in Philosophy which is responsible for awarding the Distinguished Woman Philosopher Award.