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Innovative protocol designs in early phase clinical development - WHITEPAPER

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Less than 1 in 10 new drugs reach the market and around 85% of potential drug therapies do not pass early clinical trials. This suggests that increasing R&D productivity and reducing costs could start with changes in early phase clinical development. This whitepaper reviews some of the recent trends in protocol design and digitalization, as well key regulatory opportunities and challenges that those conducting clinical trials in Europe should consider.

This whitepaper explores:

  • The benefits of innovative protocol designs

  • Adaptive designs based on Basket, Umbrella, and Platform trials

  • Digital innovations reshaping trials

  • Improving regulatory confidence in novel early phase clinical development


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