Open Science and Data Sharing in Clinical Research Basing Informed Decisions on the Totality of the Evidence

Use the link above to access the full text of the article from the March 2012 issue of “Circulation: Cardiovascular and Quality Outcomes” published by the American Heart Association. A portion of the article follows: “Every day, patients and their caregivers are faced with difficult decisions about treatment. They turn to physicians and other healthcare professionals to interpret the medical evidence and assist them in making individualized decisions... Unfortunately, we are learning that what is published in the medical literature represents only a portion of the evidence that is relevant to the risks and benefits of available treatments. In a profession that seeks to rely on evidence, it is ironic that we tolerate a system that enables evidence to be outside of public view... Although industry-sponsored studies tended to have the lowest publication rates, the problem spans all study sponsors. A subsequent study found that only 46% of clinical trials funded by the National Institutes of Health were published within 30 months of completion.6 Lee and colleagues found that fewer than half of the new drug trials submitted to the US Food and Drug Administration were published within 5 years of drug approval.7 Although pivotal trials were more likely to be published, 24% remained unpublished at 5 years. Negative trials were less likely to be published, yet 34% of the positive trials were also unpublished at 5 years... Missing studies are unlikely to be missing at random, and the effect of the missing data on inferences about an intervention is not easy to predict. Hart and colleagues investigated the effect of unpublished data on the results of meta-analyses of drug trials.10 They showed that the unpublished data influenced the summary estimates such that the drug efficacy was lower in 46% of the meta-analyses and greater in 46%... Now is the time to bring data sharing and open science into the mainstream of clinical research, particularly with respect to trials that contain information about the risks and benefits of treatments in current use. This could be accomplished through the following steps...”