Legislation that would mandate the creation of a system to share de-identified clinical trial data has moved a step closer to coming into force. The text is included in the latest draft of the 21st Century Cures Act, which is almost 200 pages shorter than the original proposal.
Shortening the draft by about 50% has resulted in some sections being left on the cutting-room floor--there is no longer a proposal to expand access to Medicare data, for example--but many of the core biotech IT sections made the grade. The proposal to create a system for sharing clinical trial data for further research came through the reworking of the original draft unscathed. Other sections have been revised but retained their core purposes.
A call for the sharing of data generated in research funded by the National Institutes of Health (NIH) was given a few tweaks, notably to remove a reference to making information available to the public. Similarly, the bipartisan committee behind the draft reworked the text covering the standardization of data in a clinical trial registry--the new version is more explicit about which inclusion and exclusion criteria to include--but the overarching idea is intact.
Whether that will be the case for these or any other sections by the time legislators are done with the bill remains to be seen. The current version is the result of 12 months work by a team on the Energy & Commerce Committee who hope their bipartisan approach will stand the bill in good stead when it is assessed by their peers. That process began on April 30 when the subcommittee on health discussed the draft at a hearing attended by leaders from FDA and NIH.
- here's the act (PDF)
- read Regulatory Focus' explainer