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Introducing the need for a consensus-based framework for protocol modifications to improve trial trustworthiness.

Cora Burgwinkel1, Manon Gicquel2, Isabelle Boutron3,4,5

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Summary
This summary is machine-generated.

Standardized reporting of protocol modifications in randomized controlled trials (RCTs) is crucial for transparency and trust. A consensus-based framework is needed to clearly communicate changes, their reasons, and impact on trial results.

Keywords:
Protocol modificationsReporting standardsResearch reproducibilitySelective reporting

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Area of Science:

  • Clinical Trials
  • Research Integrity
  • Biostatistics

Background:

  • Randomized controlled trials (RCTs) transparency has improved via registration and public protocols/statistical analysis plans (SAPs).
  • Reporting of protocol and SAPs modifications lacks standardization, hindering identification of changes, rationale, and impact on results.
  • Existing transparency initiatives leave gaps in understanding the implications of modifications for trial trustworthiness.

Purpose of the Study:

  • Advocate for a consensus-based framework for reporting protocol modifications in RCTs.
  • Address the tension between the necessity of modifications and their potential risks (bias, undermined confidence).
  • Highlight challenges faced by readers, reviewers, and decision-makers in evaluating protocol changes.

Main Methods:

  • Review empirical evidence on the prevalence and nature of protocol modifications.
  • Discuss the implications of these modifications for trial validity, interpretation, and credibility.
  • Analyze the difficulties in identifying and assessing protocol changes due to dispersed information.

Main Results:

  • Protocol modifications are common and necessary but can introduce bias if not properly justified.
  • Lack of standardized reporting burdens stakeholders in evaluating the impact of changes.
  • Current practices make it difficult to ascertain the trustworthiness of RCT findings when modifications occur.

Conclusions:

  • Standardized and transparent reporting of protocol modifications is essential for critical evaluation.
  • Advocate for a consensus-based reporting framework, potentially using a Delphi process.
  • Improved reporting will enhance transparency, facilitate critical appraisal, and strengthen confidence in RCT findings.