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Multidisciplinary considerations for implementing Bayesian borrowing in basket trials.

Kristine R BroglioJenny E BlauElizabeth A PillingJames M S Wason
Published in: Drug discovery today (2024)
Drug development has historically relied on phase I-III clinical trials including participants sharing the same disease. However, drug development has evolved as the discovery of mechanistic drivers of disease demonstrated that the same therapeutic target may provide benefits across different diseases. A basket trial condenses evaluation of one therapy among multiple related diseases into a single trial and presents an opportunity to borrow information across them rather than viewing each in isolation. Borrowing is a statistical tool but requires a foundation of clinical and therapeutic mechanistic justification. We review the Bayesian borrowing approach, including its assumptions, and provide a framework for how this approach can be evaluated for successful use in a basket trial for drug development.
Keyphrases
  • clinical trial
  • phase iii
  • phase ii
  • study protocol
  • open label
  • small molecule
  • health information
  • randomized controlled trial
  • quality improvement
  • high throughput
  • stem cells
  • healthcare
  • social media
  • single cell