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How to Ensure You Get Optimal Study Power for Your Investment in Time and Cost

Suppose a statistician were to tell a clinical trial sponsor that it was possible to improve the power of the sponsor’s study without any additional investment in time and cost. The sponsor could still secure the many benefits of an existing study design, but the overall risk of a good drug being rejected would decrease.

Now imagine working with a statistician who could show you all of the clinical trial designs that secured the most power for any combination of time and cost. Taking the specific context of your study into consideration, every single optimized study design would be available to you for selection. Cytel’s new position paper takes trial sponsors through a step-by-step process for how to obtain this full set of optimized clinical trial designs.

The Pareto Frontier is a concept from economic choice theory, which mathematically represents the set of preferences where improvement along one parameter is not possible without reduction along another. Taken individually, each point on the Pareto Frontier is Pareto Optimal. Cytel has adjusted this concept for the clinical development space specifically, reflecting points where sponsors can be sure that for any given investment in cost and time, the maximum possible power is available.

The difference is that in Cytel’s conception, each of these points on the Pareto Frontier also corresponds with one or more clinical trial designs. This means that given the right technology, like Cytel’s SolaraTM, sponsors can quickly determine a set of clinical trial designs that are Pareto optimal given their business goals. Choosing a study design from this set ensures that a sponsor can be sure that no greater statistical power is possible, given their resource constraints. This in turn maximizes the opportunity to get a good drug to market.

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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 Society for Women in Philosophy's Eastern Division, which is responsible for awarding the Distinguished Woman in Philosophy Award.