The importance of clinical trial data sharing: toward more open science.

In cardiovascular medicine, as in all other medical disciplines, realizing the full value of clinical trial research data requires that the data be accessible to the research community and others who might be able to use them. Traditionally, the dissemination of knowledge derived from clinical research has been limited in scope: Investigators who have designed and conducted clinical trials make the decisions about which statistical analyses to conduct and then publish peer-reviewed articles to disseminate their findings. Clinical trial data are considered the property of the investigators and the entities that sponsored the research, with little or no opportunity for investigators external to the original study team to access the data. This traditional model is based on dissemination via print publication, the origins of which date back to the 17th century. By continued adherence to this model in the age of electronic knowledge exchange, our understanding of clinical interventions is limited by our lack of access to comprehensive data from all clinical trials in several ways. First, a select number of individuals decide which analyses to conduct, choosing some at the exclusion of others, while an analysis that might have been of great interest to another investigator (and which may have a direct bearing on clinical practice) may not be performed. Second, among these findings generated, a select number might be included in any peer-reviewed publication, leaving the research community and clinicians at a loss to know about findings generated but not disseminated. In fact, by comparing published articles with trial protocols, 50% of efficacy and 65% of harm outcomes per trial have been shown to be incompletely reported and biased toward the reporting of statistically significant findings.1 Third, among all trials conducted, there may be significant publication delays, as happened with the Ezetimibe and Simvastatin in Hypercholesterolemia …

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