Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.

摘要

In response to 23 public- and private-sector sponsors, the Institute of Medicine assembled an ad hoc committee to develop guiding principles and a framework (activities and strategies) for the responsible sharing of clinical trial data. Responsible sharing of clinical trial data will allow other investigators to carry out additional analyses and reproduce published findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators.