The Institute of Medicine released an extensive report that recommends government agencies and companies share data from research studies that they fund. The report’s authors set out numerous action steps that clinical trial sponsors are encouraged to follow in order to widen access, which include developing specific plans for sharing data, such as granting access through third-party web sites; and adopting recommended timetables for releasing both summary and complete data packages after studies have been finished and published.
“Our recommendations represent an attempt to balance the interests of different stakeholders with the public interest of having the best information possible regarding the effectiveness and safety of therapies,” stated Bernard Lo, who chaired the IOM committee that generated the widely anticipated report, generated in response to ongoing debate over access to clinical trial data. “The issue is no longer whether to share clinical trial data, but what specific data to share, at what time and under what conditions,” according to Mr. Lo.
Specifically, the IOM suggests that summary level results, including adverse event information, should be publicly available no later than one year after a trial has been completed. And a complete data package, which includes the full protocol and statistical analysis plan, among other things, should be shared no later than 18 months after a study is completed.
For more information about The Institute of Medicine, please click here.
To read the full IOM report, please click here.