Data privacy protection in scientific publications: process implementation at a pharmaceutical company

Area of Science:

• Clinical research
• Data privacy
• Medical informatics

Background:

• Sharing clinical trial data is vital for scientific advancement.
• Linking publication data with public information increases participant reidentification risk.
• Takeda implemented a review process to mitigate these privacy concerns.

Purpose of the Study:

• To define criteria for assessing and minimizing reidentification risk in clinical trial publications.
• To implement and evaluate a review process for ensuring participant privacy before data dissemination.

Main Methods:

• Reviewed abstracts, manuscripts, posters, and presentations for direct and indirect identifiers.
• Assessed privacy impact, focusing on rare diseases and small study groups.
• Calculated reidentification risk ratios and applied risk-minimization strategies.

Main Results:

• 13% of publications posed a reidentification risk or had inappropriate data sharing plans.
• Changes were required in 1/110 abstracts, 58/275 manuscripts, 5/87 posters, and 3/58 presentations.
• Direct and indirect identifiers were present in 11% and 34% of documents, respectively, despite risk-minimization efforts.

Conclusions:

• De-identification and controlled data sharing improve clinical trial participant privacy.
• Additional safeguards are recommended to achieve higher data privacy standards.