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

S Dolley1, T Norman2, D McNair2

  • 1Open Global Health, 710 12th St South, Ste 2523, Arlington, VA, 22202, USA. shawn@openglobalhealth.org.

Trials
|April 19, 2024
PubMed
Abstract

Insights

Many clinical trials are uninformative. A new maturity model offers a framework for scientific design reviews to improve clinical trial outcomes and funding return-on-investment.

Area of Science:

  • Clinical trial methodology and biostatistics.
  • Research design and protocol development.

Background:

  • Many clinical trials conclude without providing definitive answers, leading to uninformative results.
  • Current regulatory and ethical reviews for clinical trial protocols do not adequately address scientific design, biostatistics, or methodology.
  • A gap exists in documented standards for funders to conduct scientific design reviews post-peer review and pre-funding.

Discussion:

  • Scientific reviews of clinical trial designs focused on informativeness may improve outcomes and return-on-investment.
  • A maturity model can facilitate knowledge transfer and self-assessment for scientific design reviews.
  • The proposed model assesses 11 process areas across 5 maturity levels to enhance trial protocols.

Key Insights:

  • A maturity model is presented for scientific design reviews of clinical trial protocols.
  • The model aims to reduce the risk of trial failure and uninformativeness.
  • It provides prescriptive guidance for improving post-funding review attributes.

Outlook:

  • Enhancing trial informativeness can improve participant commitment and accelerate cures.
  • The model supports funders in meeting fiduciary responsibilities and mission goals.
  • It complements traditional pre-funding peer review by offering detailed methodological assessment.
Keywords:
Clinical trialDesign reviewInformativenessMaturity modelTrial methods

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