'Financially adaptive trials', as the name implies, combine key aspects of adaptive trial design and financial analytics. Adaptive design elements, such as sample size re-estimation, interim analyses and Phase II/III hybrid designs, provide more flexibility to balance risk, cost and time in clinical trials. By systematically and iteratively evaluating how different trial design parameters directly influence financial value, one can enable transparent decision-making, maximize the value of R&D programmes and portfolios, and enable a broader range of options for R&D financing and resource allocation. In this article, we illustrate the application of this trial design strategy, highlight the potential benefits and discuss the challenges to implementing it.

Value of financially adaptive trials

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