Bipartisan Bill Would Build Reusable Clinical Trial Networks, With a Focus on Rare Disease

Legislation introduced by Rep. Jake Auchincloss (D-Mass.) and Rep. Morgan Griffith (R-Va.) would make it easier for patients to join clinical trials and shorten the time it takes to start them, according to CNBC Cures.¹

The so-called “Faster Clinical Trials Act” would also encourage drugmakers to use computer simulations in early-stage drug development and address some of the common reasons the FDA suspends trials.

The bill takes aim at how trials are typically built. Infrastructure is usually dismantled when a trial ends, even though many elements repeat from trial to trial for a given disease or treatment type. The legislation aims to create a network of reusable trial sites.

“So you’re not recreating the wheel every time you’re trying to do a new drug,” Auchincloss said in an interview with CNBC Cures. “You have a platform, and now you’re just trying one thing after another.”

Bringing the trial to the patient

Under the bill, patients could receive an experimental drug in their regular doctor’s office rather than traveling to a trial site, with researchers tracking progress through Zoom calls, electronic medical records, or wearable technology.

Griffith said some of his southwest Virginia constituents, who want to join studies of new treatments for black lung disease, live a two-hour drive or longer from medical centers that typically host trials.

“We’re trying to bring the clinical trial to the patient instead of the model today of bringing the patient to the clinical trial,” he said in an interview.

Mark McClellan, founding director of the Duke-Margolis Institute for Health Policy at Duke University, which helped craft the legislation, described the aim this way: “The idea is to make it as easy as possible for the patient to stay right where they are.”

Funding, structure, and limits

The bill creates a Center for Clinical Trial Innovation at the FDA to coordinate the site networks. It also gives the agency’s Rare Disease Innovation Hub specific instructions, including authority to consult with drugmakers about their concerns and to help agency review teams.

CNBC Cures reported that the legislation directs as much as $75 million in annual funding to the FDA over five years, with networks prioritizing rare and chronic diseases. The goal is to cut trial costs and enrollment time by at least 30%. Auchincloss compares the model to the one the Cystic Fibrosis Foundation built in the 1990s.

There are limits. McClellan said intensive treatments, such as gene therapies, will still need to be given at academic medical centers. Advances like in vivo gene editing, however, let patients leave the hospital the same day and be monitored remotely, he added.

Griffith said the bill likely won’t get a vote until next year. Auchincloss’s office said it is working with a bipartisan group of senators on a similar Senate measure later this year.

Arrives a week after FDA’s rare disease framework

The bill follows the FDA’s Rare Disease Framework Initiative, announced just a week ago. Led by the FDA’s Rare Disease Innovation Hub, the initiative is a broad effort to build a regulatory approach tailored to developing drugs and biologics for rare diseases, and it begins with an Oct. 28 public meeting at the FDA’s White Oak campus facilitated by the Reagan-Udall Foundation for the FDA.²

The FDA’s white paper puts the gap in stark terms: only approximately 5% of recognized rare diseases have an FDA-approved treatment. It also states that regulatory flexibility has not been applied consistently across review divisions, and that inconsistency is a core problem the framework is intended to fix.

Amy Comstock Rick, JD, director of the Rare Disease Innovation Hub, said in the agency’s release: “This new framework will enhance consistency and predictability for both sponsors and for patients.”

References

1. New bipartisan bill aims to speed up clinical trials for rare disease treatments. CNBC Cures. October 22, 2026. https://www.cnbc.com/2026/10/22/bipartisan-bill-aims-to-speed-up-trials-for-rare-disease-treatments.html
2. FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations. Applied Clinical Trials. October 14, 2026. https://www.appliedclinicaltrialsonline.com/view/fda-launches-rare-disease-framework-initiative-reimagine-drug-development-small-patient-populations