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A maturity model for the scientific review of clinical trial designs and their informativeness.

Shawn DolleyThea NormanD McNairD Hartman
Published in: Trials (2024)
This tool allows for prescriptive guidance on next investments to improve attributes of post-funding reviews of trials, with a focus on informativeness. Traditional pre-funding peer review has limited capacity for trial design review, especially for detailed biostatistical and methodological review. Select non-industry funders have begun to explore or invest in post-funding review programs of grantee protocols, based on exemplars of such programs. Funders with a desire to meet fiduciary responsibilities and mission goals can use the described model to enhance efforts supporting trial participant commitment and faster cures.
Keyphrases
  • clinical trial
  • study protocol
  • public health
  • phase iii
  • systematic review
  • randomized controlled trial
  • open label
  • double blind
  • global health
  • meta analyses
  • placebo controlled