PLoS Medicine: Open Clinical Trial Data for All? A View from Regulators 2012-08-20


Use the link above to access the full text article by Eichler et al published in PLoS Medicine on April 10, 2012. The a brief introduction to the article reads as follows: “Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy... Doshi and colleagues argue that the full clinical trial reports of authorized drugs should be made publicly available to enable independent re-analysis of drugs' benefits and risks [1]. We offer comments on their call for openness from a European Union drug regulatory perspective. For the purpose of this discussion, we consider ‘clinical study reports’ to comprise not just the protocol, summary tables, and figures of (mostly) randomized controlled trials (RCTs), but the full ‘raw’ data set, including data at the patient level [2]. We limit discussion to data on drugs for which the regulatory benefit-risk assessment has been completed...”



08/16/2012, 06:08

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oa.medicine oa.plos oa.europe oa.standards oa.pharma oa.privacy oa.ema oa.encepp oa.journals



Date tagged:

08/20/2012, 18:23

Date published:

04/12/2012, 17:35