How should individual participant data (IPD) from publicly funded clinical trials be shared?

Area of Science:

• Clinical Trials Methodology
• Data Sharing Policies
• Research Ethics

Background:

• Individual participant data (IPD) sharing from completed clinical trials is essential for advancing medical research and patient benefit.
• The Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR) developed guidance to standardize IPD sharing from publicly funded clinical trials.

Purpose of the Study:

• To develop and disseminate practical guidance for the responsible sharing of individual participant data (IPD) from publicly funded clinical trials.
• To ensure IPD sharing practices align with ethical considerations, funder mandates, and journal requirements.

Main Methods:

• Guidance development involved a four-phase approach: policy review, a UK-wide survey of Clinical Trials Units (CTUs), expert committee input, and open consultation.
• The project was funded by the MRC HTMR (MR/L004933/1-R39).

Main Results:

• Key principles for good practice include controlled access with transparent request review, obtaining participant consent for data sharing while ensuring privacy, and establishing sustainable resource models.
• The guidance has received endorsements from major research organizations including Cancer Research UK, the MRC Methodology Research Programme Advisory Group, the Wellcome Trust, and the UK Clinical Research Collaboration (CRC) Registered CTU Network.
• The National Institute for Health Research (NIHR) expressed support for the application of this guidance.

Conclusions:

• Implementing these principles enhances transparency and consistency in sharing IPD from publicly funded trials.
• Adherence to the guidance will help trials meet data sharing requirements set by funders and journals.