Data sharing in research: benefits and risks for cliniciansBMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g237 (Published 23 January 2014) Cite this as: BMJ 2014;348:g237
- Elliott Antman, professor of medicine, cardiovascular division, Brigham and Women’s Hospital, and associate dean for clinical/translational research, Harvard Medical School, Boston, MA
The cycle of research begins with identification of an idea, design of the study to answer the scientific question that is posed, conducting and analyzing the findings, and publishing the results. Figure 1 shows the position of the open source, open data, and open access components of the open science concept superimposed on the cycle of research.⇓ One can readily advocate, in principle, for open data to provide doctors and their patients all the data needed for optimum decision-making (figure 2).⇓ 1
To illustrate the issues involved, however, consider the flow of data when a clinical trial is completed (figure 3).⇓ A series of raw databases are created. They are populated from the case report forms, and contain patient level information on such topics as baseline demographics, concomitant medications, study drug compliance, suspected endpoint events, clinical laboratory data, and adverse events. Other raw databases might include the final adjudication by the blinded endpoint committee as to whether an endpoint occurred, genetic data, quality of life survey results, and core laboratory data. A data dictionary is developed to link the information from the raw databases to several derived databases that cover items such as endpoints, time to event, and allocation to treatment arm. The derived databases are the source from which data tables are generated for preparation of manuscripts that ultimately appear in the medical …
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