Open Science and Data Sharing in Clinical Research

Abstract

A patient tentatively enters the examination room. A decision looms, and the patient waits with some trepidation. A doctor soon appears and pulls up a chair, prepared for the discussion by having conscientiously reviewed the medical literature, examined the evidence-based systematic reviews, and highlighted the relevant information. The ensuing conversation reflects on the patient's treatment goals and the published information about the benefits and harms of the available options. The tension breaks with a decision, and plans for the next steps are put in place. 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. Those who own data, usually scientists or industry, have the choice of what, where, and when to publish. As a result, our medical literature portrays only a partial picture of the evidence about clinical strategies, including drugs and devices. Experts have recently drawn attention to this issue, including contributions in this issue of our journal, but there is resistance to change.1–5 Studies document that a remarkable percentage of trials are not published within a reasonable period after they are completed. Ross and colleagues reported that fewer than half of trials were published within 2 years of completion.4 Although industry-sponsored studies tended to have the …