Data sharing in clinical trials - practical guidance on anonymising trial datasets

Area of Science:

• Clinical Trials Methodology
• Data Management
• Health Informatics

Background:

• Increasing demand from non-commercial funders for trial data access post-primary analysis.
• Need to balance data sharing with participant confidentiality, legal, and regulatory requirements.

Purpose of the Study:

• To provide practical guidance on anonymising clinical trial datasets.
• To develop a controlled access model for sharing anonymised trial data.

Main Methods:

• Anonymisation of a recently completed trial dataset using Medical Research Council Hubs for Trials Methodology Research (MRC HTMR) guidelines.
• Classification of variables into direct, indirect, and superfluous identifiers with tailored anonymisation methods.
• Implementation of a controlled access model and data release procedure.

Main Results:

• Successful creation of a controlled access model for anonymised trial data sharing.
• Development of a bespoke anonymised dataset for a completed trial.
• Established procedures for data anonymisation and release.

Conclusions:

• A practical solution for anonymising clinical trial data has been implemented.
• Learnings gained on process efficiency, balancing anonymity with data utility, and future work.
• The developed method facilitates secure trial data sharing while protecting participant privacy.