Towards agreement on best practice for publishing raw clinical trial data

Area of Science:

• Biomedical Research
• Clinical Trials
• Scientific Publishing

Background:

• Research funding agencies increasingly mandate open access for research outputs and raw data.
• The journal Trials is developing best practices for publishing raw data from randomized controlled trials (RCTs).

Discussion:

• Key challenges for raw data publication include patient privacy concerns and data ownership issues.
• Current guidance and mandates often lack agreed-upon policies to address these data publication challenges.

Key Insights:

• Establishing clear policies for patient privacy and data ownership is crucial for successful raw data publication.
• There is a need for collaboration between publishers, ethics committees, funders, and researchers to define these policies.

Outlook:

• Proposed next steps involve developing comprehensive policies for journal editors, publishers, ethics committees, and researchers.
• Alternatives like restricted-access repositories are being explored for managing raw clinical trial data.