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Using Customer Input and Decision Support Tools to Optimize Clinical Trial Design

By Noah M. Pines and Tim Brewer, ThinkGen

The cost of pivotal clinical trials continues to rise as does the time required for completion. While the costs can vary considerably based on the number of subjects, trial length and endpoints, they are among the most expensive components of bringing a new drug candidate to market. Indeed, according to Nature Reviews, the median cost of a Phase III study is over $21 million.

Our view is that market research early in the development process can significantly enhance and define the clinical program, so that the clinical program can most beneficially support not just the evaluation of safety and efficacy, but also all the other parameters such as claims and labeling that influence the success of a product in the marketplace.

There already exists a well-established framework for incorporating customer input to inform the commercial development process. While the road map may differ slightly by company and therapeutic category, it typically includes market research to understand the market landscape and the customer journey. It also includes target product profile testing, demand forecasting, product positioning, market segmentation and message development.

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