Trends in Pharmacological Sciences

Trends in Pharmacological Sciences - December 2013
English | 53 pages | True PDF | 11.22 MB

Trends in Pharmacological Sciences

Making raw data from clinical trials widely publically available should reduce selective reporting biases and enhance the reproducibility of and trust in clinical research. The optimal procedures for data sharing are hotly debated. Some of the caveats and limitations in proposed data-sharing policies are potentially restrictive, and we argue in favor of more widespread availability of data from clinical research.

Peer-reviewed publications describing the results of randomized clinical trials are a filtered, condensed summary of raw data. Placing one’s trust in the published literature implicitly assumes that what we are seeing is not distorted (i.e., the underlying data and their analyses are consistent with that reported in the publication) and is complete (i.e., there are no unpublished trials or unreported relevant outcomes). However, the cases of Vioxx, Avandia, Celebrex, Paxil, Tamiflu, and Neurontin suggest that these assumptions are often unfounded. 

Concern over the gap between what we see and what actually occurred in a published study is a major reason that access to clinical trial data has emerged as an international issue(https://www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html). There are many additional reasons why wider data sharing would be a good idea beyond double-checking published results. These include the ability to use these data in more definitive meta-analyses of individual-level data, transparent performance of exploratory, secondary analyses that can be verified by outsiders, and avoidance of wasting resources for redundant studies or analyses.

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