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CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.

Craig S Mayer1, Nick Williams1, Vojtech Huser1

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The CONSIDER statement provides recommendations to enhance clinical trial data sharing. This aims to improve the availability and re-usability of individual participant data from studies.

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Area of Science:

  • Clinical Trials
  • Data Science
  • Biomedical Research

Background:

  • Research sponsors increasingly mandate data sharing from human clinical trials.
  • Ensuring availability and re-usability of individual participant data is crucial for scientific advancement.

Purpose of the Study:

  • To introduce the CONSIDER statement, a framework designed to standardize and improve clinical trial data sharing practices.
  • To enhance the accessibility and utility of individual participant data derived from clinical trials.

Main Methods:

  • Development of the CONSIDER statement involved reviewing shared data and study artifacts from completed clinical trials.
  • Analysis included data from ClinicalTrials.gov and various data sharing platforms.
  • Recommendations were structured into seven key sections covering data format, sharing, study design, and more.

Main Results:

  • The CONSIDER statement offers a comprehensive set of recommendations for improving clinical trial data sharing.
  • It includes a checklist, a full form with detailed guidance, and a scoring methodology for assessing adherence.
  • The statement addresses critical aspects such as data format, de-identification, and platform selection.

Conclusions:

  • The CONSIDER statement provides a structured approach to enhance the sharing and re-usability of clinical trial data.
  • Ongoing feedback collection (Phase 2) aims to refine the statement for broader adoption and impact.
  • Implementation of the CONSIDER statement can facilitate more robust and reproducible clinical research.