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

Abstract

Background/aims: 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 8 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: Fifty-nine 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.

Keywords: Clinical trials; data anonymisation; data curation; datasets; guidelines; patient identification systems; personally identifiable information; systematic review.

Figure 1.

Most suggested method to release anonymised datasets from clinical trials. Risk of re-identification is a complex variable, which is minimised using controlled access. The description of risk is out of scope for this review. Other processes: five studies described usage of open access instead, one study mentioned both controlled and open access for data release and the remaining two studies did not discussed data release.