Open Clinical Trial Data for All? A View from Regulators

Posted by National Health Index Clinical Trial News Thursday, April 19th, 2012

Why Trial Data Should Be Open for All

Citation: Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202. doi:10.1371/journal.pmed.1001202

Plosmedicine.org: Published: April 10, 2012

First and foremost, we agree with Doshi et al. that clinical trial data should not be considered commercial confidential information; most patients enrolling in clinical trials do so with an assumption of contributing to medical knowledge, and “non-disclosure of complete trial results undermines the philanthropy” [1].

The potential benefits for public health of independent (re-)analysis of data are not disputed and, in an open society, trial sponsors and regulators do not have a monopoly on analyzing and assessing drug trial results. Yet, the different responsibilities of regulators and independent analysts have to be acknowledged. Regulators, unlike academicians, are legally obliged to take timely decisions on the availability of drugs for patients, even under conditions of uncertainty.

Going beyond the merits of independent meta-analysis, we foresee other, potentially more important benefits from public disclosure of raw trial data. For example, RCT datasets enabled the development of predictive models for patient selection to appropriate treatments [3],[4]. Taking this notion a step further, we envisage machine learning systems that will allow clinicians to match a patient’s electronic health record directly to RCT and observational study data sets for better, individualized therapeutic decisions (L. Perez-Breva, personal communication). Read More