JAMA   
October 12, 2011, Vol 306, No. 14, pp 1513-1614
http://jama.ama-assn.org/current.dtl

Commentaries
A Model for Dissemination and Independent Analysis of Industry Data
Harlan M. Krumholz, Joseph S. Ross
JAMA. 2011;306(14):1593-1594.doi:10.1001/jama.2011.1459

Extract
Each day, patients and their physicians make treatment decisions with access to only a fraction of the relevant clinical research data. Many clinical studies, including randomized clinical trials, are never published in the biomedical literature. 1, 2 Among those that are published, key information is often not presented, such as data on specific outcomes and safety end points. 3, 4 Moreover, patient-level data from clinical trials are rarely publicly available, leaving investigators to conduct meta-analyses of summary-level data, an approach with limitations. 5

Current clinical research standards lack sufficiently strong requirements for transparency and availability. There are no uniform international standards requiring that study protocols, statistical analysis plans, and study results be made available, and there are no requirements that completed clinical trial data be publicly available or posted for independent analysis. Even data submitted to the US Food and Drug Administration are not made publicly available