Expanded Availability For Data From Clinical Trials

Data from a large swath of clinical trials would be available to the public under new rules proposed by FDA and NIH late last month. The reporting requirement would apply to most interventional studies of drugs, biological products, and devices, including those that are currently unapproved or unlicensed. In most cases, the rules would not apply to Phase I trials or early feasibility studies. The proposed rules also would clarify and expand what data must be submitted to NIH’s online database before a clinical trial begins and what results must be reported after the trial has concluded. Reporting both positive and negative results is especially important because it prevents duplication of trials and assures trial participants that the data collected about them have been put to good use, NIH says.