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