February 4, 2015
The Institute of Medicine (IOM) of the National Academy of Sciences has recently published a report recommending that government agencies and companies share data from research studies they fund. The report outlines several steps that clinical trial sponsors are encouraged to take in order to widen access. These 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. The report suggests that summary level results should be publicly available no later than one year following a trial completion. Also, a complete data package, which includes the full protocol and statistical analysis plan, should be shared no later than 18 months after a study is completed.