Abstract
BackgroundRegulatory agencies, such as the European Medicines Agency and Health Canada, are requiring the public sharing of clinical trial reports that are used to make drug approval decisions. Both agencies have provided guidance for the quantitative anonymization of these clinical reports before they are shared. There is limited empirical information on the effectiveness of this approach in protecting patient privacy for clinical trial data.MethodsIn this paper we empirically test the hypothesis that when these guidelines are implemented in practice, they provide adequate privacy protection to patients. An anonymized clinical study report for a trial on a non-steroidal anti-inflammatory drug that is sold as a prescription eye drop was subjected to re-identification. The target was 500 patients in the USA. Only suspected matches to real identities were reported.ResultsSix suspected matches with low confidence scores were identified. Each suspected match took 24.2 h of effort. Social media and death records provided the most useful information for getting the suspected matches.ConclusionsThese results suggest that the anonymization guidance from these agencies can provide adequate privacy protection for patients, and the modes of attack can inform further refinements of the methodologies they recommend in their guidance for manufacturers.
Highlights
There is growing recognition within the research community that the re-analysis of clinical trial data can provide new insights compared to the original publications [1]
The confidence score was determined by expert assessment based on the fit of the match, such as the obituaries and narratives with the records on the anonymized report or other known information based on the study, age, gender, and cause of death
It was possible to identify two subjects for which there was some confidence of a match based on use of the drug, surgery, date of surgery, suspected or confirmed diabetic condition, and additional information from other clinical/medical visits, the confidence scores were only 1 and 2
Summary
There is growing recognition within the research community that the re-analysis of clinical trial data can provide new insights compared to the original publications [1]. A future phase of Policy 0070 is expected to address the release of individual participant data, but at the time of writing no date has been set for this. Regulatory agencies, such as the European Medicines Agency and Health Canada, are requiring the public sharing of clinical trial reports that are used to make drug approval decisions. Both agencies have provided guidance for the quantitative anonymization of these clinical reports before they are shared. There is limited empirical information on the effectiveness of this approach in protecting patient privacy for clinical trial data
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