Lawmakers in the U.S. House introduced legislation on Thursday designed to overhaul how experimental therapies are tested, seeking to make clinical trials faster, less expensive, and accessible to patients far from major academic hospitals, CNBC reported.
The bipartisan measure, titled the Faster Clinical Trials Act, was sponsored by Democratic Rep. Jake Auchincloss and Republican Rep. Morgan Griffith. The bill seeks to replace the conventional trial model, where specialized research infrastructure is assembled for a single study and subsequently dismantled once testing ends, with enduring networks of reusable trial locations.
Bringing Studies to Patients
Under the proposed legislation, the Food and Drug Administration would establish a Center for Clinical Trial Innovation to coordinate trial networks, backed by up to $75 million in annual funding across five years. The framework is intended to prioritize rare and chronic illnesses, with an overarching goal of reducing trial costs and enrollment timelines by at least 30 percent.
Instead of requiring patients to make long trips to distant research institutions, the bill promotes point-of-care studies. Participants could receive experimental medicines at their local physician’s practice, while research teams monitor their condition through wearable technology, virtual meetings, and electronic health records.
“We’re trying to bring the clinical trial to the patient instead of the model today of bringing the patient to the clinical trial,” Griffith told CNBC.
Griffith noted that the approach would benefit not only rare disease patients, but also individuals in his southwest Virginia congressional district seeking treatments for conditions such as black lung disease, who often live two hours or more from major trial hubs.
Auchincloss likened the approach to a platform established by the Cystic Fibrosis Foundation during the 1990s. “So you’re not recreating the wheel every time you’re trying to do a new drug,” Auchincloss told CNBC Cures. “You have a platform, and now you’re just trying one thing after another.”
Addressing Rare Disease Hurdles
Finding sufficient participants remains one of the largest obstacles in rare disease research, where specific conditions may affect only dozens of people nationwide. The legislation would also encourage the use of electronic medical records to compile natural history databases. These records can serve as control groups, reducing the need to administer placebos to participants facing severe or progressive conditions.
The bill also directs the FDA to encourage computer simulations in early research phases and help resolve common regulatory issues that lead to study suspensions. It would additionally empower the agency’s Rare Disease Innovation Hub to advise pharmaceutical companies directly.
Mark McClellan, founding director of Duke University’s Duke-Margolis Institute for Health Policy, which contributed to drafting the measure, pointed out that complex procedures such as gene therapies will still require specialized centers. However, McClellan explained that innovations like in vivo gene editing allow same-day hospital discharge, enabling patients to recover and undergo monitoring at home.
Legislative Timeline Ahead
The introduction follows the FDA’s recent announcement of its Rare Disease Framework Initiative, an effort to apply greater flexibility when evaluating treatments intended for small groups of patients. Former FDA Commissioner Scott Gottlieb said on CNBC’s “Squawk Box” on Oct. 19 that the agency’s strategy provides drugmakers with stable regulatory expectations.
Griffith said a vote on the bill in the House is unlikely before next year, while Auchincloss’s office reported ongoing discussions with a bipartisan group of senators to file a companion bill later this year. Auchincloss expressed confidence that the measure will attract broad support across the political spectrum, from patient advocacy groups to pharmaceutical developers.
