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[International Multi-stakeholder Consensus Statement on Clinical Trial Integrity].

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Summary
This summary is machine-generated.

This study developed 81 consensus statements for improving randomised clinical trial (RCT) integrity. The recommendations cover the entire RCT lifecycle, aiming to enhance scientific rigor and trustworthiness.

Keywords:
Clinical trialsEnsayos clínicosIntegridad de la investigaciónMethodologyMetodologíaResearch integrity

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Area of Science:

  • Clinical Trials
  • Research Integrity
  • Evidence-Based Medicine

Background:

  • Initiatives for scientific integrity necessitate specific recommendations for randomised clinical trials (RCTs).
  • A global, multi-stakeholder consensus was sought to establish clear guidelines for RCT integrity.

Framework:

  • A consensus framework was developed using a multi-country, multidisciplinary approach.
  • Evidence synthesis from 55 systematic reviews on RCT integrity informed the process.
  • An anonymized, two-round modified Delphi survey with a defined consensus threshold was employed.

Implementation:

  • Thirty stakeholders from 15 countries across 5 continents participated.
  • The process involved trialists, ethicists, statisticians, regulators, editors, and patient representatives.
  • An 86.7% response rate was achieved in the Delphi survey.

Implications:

  • A final set of 81 consensus statements was consolidated, covering the entire RCT lifecycle.
  • These statements address general aspects, design, conduct, reporting, and post-publication issues.
  • Implementation of these statements is anticipated to significantly enhance RCT integrity.