The U.S. House of Representatives has passed the 21st Century Cures Act by a huge majority, moving legislation that mandates the creation of a system for gathering and analyzing clinical trial data a step closer to coming into force.
Representative Diana DeGette, the Democratic member of the bipartisan double act that has driven the bill forward, said the law will "encourage new disease registries" and support "safe data-sharing and digital medicine," Politico reports. The comments refer to sections of the legislation on data access and collaborative research, which call for multiple changes to how scientific data is handled and used. A central system for gathering clinical trial data for further analysis by other researchers is a centerpiece of the proposals.
If the bill comes into force in its current form, the National Institutes of Health (NIH) will have to set up a clinical trial data pilot program. The objective is to create a repository of all data from clinical trials sponsored by an agency of the Department of Health and Human Services that registered users can dig through in search of further insights. The pilot program is scheduled to run for seven years, after which the system could be adopted as a permanent piece of the research infrastructure. Another section of the bill mandates the standardization of data to make such a repository effective.
The decision about whether to pass these changes and all the others covered in the 350-page text now advances to the Senate. The overwhelming support for the bill in the House--the text passed by a vote of 344-77--suggests it can win over the Senate, too, but plenty of people outside of the capitol have criticized the proposals. And in winning over the House, the bill's sponsors accepted multiple changes, which caused the length of the text to yo-yo as existing sections were carved out and new terms added.
- read the bill (PDF)
- here's FierceBiotech's take
- and Politico's coverage