Open clinical trial data for all? A view from regulators

First among those is the issue of personal data protection or patient confidentiality, a concept that is very different from commercial confidentiality. [...]re-analysis of trial data could be misused for competitive purposes. Conceivably, analogous principles (e.g., data sharing only after receipt...

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Bibliographic Details
Published in:PLoS medicine 2012-04, Vol.9 (4), p.e1001202-e1001202
Main Authors: Eichler, Hans-Georg, Abadie, Eric, Breckenridge, Alasdair, Leufkens, Hubert, Rasi, Guido
Format: Article
Language:English
Subjects:
Clinical trials
Drug Industry
Humans
Information Dissemination
Laws, regulations and rules
Management
Medical research
Medicine
Oseltamivir - therapeutic use
Outcome Assessment, Health Care
Pharmaceutical industry
Pharmaceutical policy
Randomized Controlled Trials as Topic
Review Literature as Topic
Studies
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Summary:First among those is the issue of personal data protection or patient confidentiality, a concept that is very different from commercial confidentiality. [...]re-analysis of trial data could be misused for competitive purposes. Conceivably, analogous principles (e.g., data sharing only after receipt of a full analysis plan) could be applied to regulatory RCT data [1]. [...]we take it as self-evident that the same standard of openness should apply to all (drug) trial data, whether sponsored by industry, investigator-initiated, or sponsored by public grant-giving bodies.
ISSN:1549-1676
1549-1277
1549-1676
DOI:10.1371/journal.pmed.1001202