Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review

Aryelly Rodriguez*, Chris Tuck, Marshall Dozier, Steff C Lewis, Sandra Eldridge, Tracy Jackson, Alastair Murray, Christopher J Weir

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction
There are increasing pressures for anonymised datasets from clinical trials to be shared across the scientific community, and differing recommendations exist on how to perform anonymisation prior to sharing. We aimed to systematically identify, describe and synthesise existing recommendations for anonymising clinical trial datasets to prepare for data sharing.
Methods
We systematically searched MEDLINE®, EMBASE, and Web of Science from inception to 08 February 2021. We also searched other resources to ensure the comprehensiveness of our search. Any publication reporting recommendations on anonymisation to enable data sharing from clinical trials was included. Two reviewers independently screened titles, abstracts and full text for eligibility. One reviewer extracted data from included papers using thematic synthesis, which then was sense-checked by a second reviewer. Results were summarised by narrative analysis.
Results
59 articles (from 43 studies) were eligible for inclusion. Three distinct themes are emerging: anonymisation, de-identification and pseudonymisation. The most commonly used anonymisation techniques are: removal of direct patient identifiers; and careful evaluation and modification of indirect identifiers to minimise the risk of identification. Anonymised datasets joined with controlled access was the preferred method for data sharing.
Conclusions
There is no single standardised set of recommendations on how to anonymise clinical trial datasets for sharing. However, this systematic review shows a developing consensus on techniques used to achieve anonymisation. Researchers in clinical trials still consider that anonymisation techniques by themselves are insufficient to protect patient privacy, and they need to be paired with controlled access.
Original languageEnglish
Article numberCT-21-0180
Number of pages12
JournalClinical Trials
Early online date22 Jun 2022
DOIs
Publication statusE-pub ahead of print - 22 Jun 2022

Keywords

  • Clinical trials
  • Systematic review
  • Data anonymisation
  • Patient identification systems
  • Personally identifiable information
  • Datasets
  • Data curation
  • Guidelines

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