关键词：临床试验；数据共享；医疗措施
摘 要：Clinical trials are crucial to determining the safety of medical interventions and their ability to achieve particular health outcomes. Clinical trials are required by regulatory authorities around the world before a new medical product can be brought to market, or before a new indication, formulation, or target population can be approved for an intervention already on the market (ICH, 1995). After a products introduction, additional clinical trials are commonly conducted by industry, government, and academia to further define the relative safety and efficacy (or effectiveness) of the product. Clinical trials are also used to study interventions that do not involve regulated medical products, for example, surgical techniques, behavioral interventions, or studies designed to improve disease management practice (Califf, 2013). Vast amounts of data are generated over the course of a clinical trial. These data are held by the sponsors conducting the clinical trial, and in some instances, by participants or their advocates (Drazen, 2002; Terry and Terry, 2011). Depending on the regulatory jurisdiction, data might or might not be shared or made available to the public for secondary uses. Shared data might include both summary data and individual patient data. In the United States, if a sponsor is seeking regulatory approval, data are shared in confidence with regulators. Select study data might also be made available to individual researchers on a case by case basis upon request, or could be made publicly available, usually at the summary level, for example, through publication in a peer-reviewed journal or through publicly accessible clinical trial registration sites.