Author Affiliations: Section of Cardiovascular Medicine and the Robert Wood Johnson Clinical Scholars Program (Dr Krumholz), and Section of General Medicine (Dr Ross), Department of Internal Medicine, Yale University School of Medicine; Section of Health Policy and Administration, Yale School of Public Health, and the Center for Outcomes Research and Evaluation (Dr Krumholz), Yale–New Haven Hospital, New Haven, Connecticut.
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
Krumholz HM, Ross JS. A Model for Dissemination and Independent Analysis of Industry Data. JAMA. 2011;306(14):1593-1594. doi:10.1001/jama.2011.1459