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International multi-stakeholder consensus statement on clinical trial integrity.

Khalid Saeed Khan1,

  • 1CIBERESP, University of Granada, Granada, Spain.

BJOG : an International Journal of Obstetrics and Gynaecology
|May 10, 2023
PubMed
Summary

A global consensus developed 81 statements to improve the integrity of randomised clinical trials (RCTs). This initiative involved diverse experts and systematic reviews to cover the entire RCT lifecycle, aiming for enhanced research quality.

Keywords:
randomised controlled trialsresearch integrity

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Area of Science:

  • Clinical Trials
  • Research Integrity
  • Evidence-Based Medicine

Background:

  • Randomised clinical trials (RCTs) are crucial for medical evidence.
  • Ensuring the integrity of RCTs is vital for reliable research outcomes.
  • A need exists for comprehensive guidelines to uphold RCT integrity across all stages.

Purpose of the Study:

  • To establish a consensus-based set of statements for enhancing randomised clinical trial integrity.
  • To develop a framework covering the entire lifecycle of RCTs.

Main Methods:

  • International multi-stakeholder consensus development.
  • Evidence synthesis from 55 systematic reviews on RCT integrity.
  • Anonymised two-round modified Delphi survey with a consensus threshold.
  • A final consensus development meeting with 30 international experts.

Main Results:

  • A final set of 81 consensus statements was consolidated.
  • Statements cover the entire RCT lifecycle: general aspects, design, conduct, reporting, post-publication, and future research.
  • The consensus included input from diverse stakeholders (triallists, ethicists, regulators, etc.) across five continents.

Conclusions:

  • The developed consensus statements are expected to enhance RCT integrity.
  • Implementation of these guidelines will contribute to more trustworthy clinical research.