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

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.