Bipartisan bill would move rare disease clinical trials to patients' local doctors

Faster Clinical Trials Act creates reusable trial networks and targets 30% cuts in cost and enrollment time

By LineZotpaper

Published22 October 2026

Read Time3 min

Bipartisan US lawmakers this week introduced the Faster Clinical Trials Act, legislation designed to speed up research into rare disease treatments by creating reusable clinical trial networks and letting patients participate from their local doctor's office. The bill, sponsored by Democratic Rep. Jake Auchincloss and Republican Rep. Morgan Griffith, would direct up to $75 million a year to the FDA and comes a week after the agency announced its own rare disease initiative.

Democratic Rep. Jake Auchincloss of Massachusetts and Republican Rep. Morgan Griffith of Virginia introduced the Faster Clinical Trials Act, which aims to tackle two recurring problems in drug development: recruiting enough patients and the time and cost of standing up trials. The bill would create a network of reusable clinical trial sites so infrastructure does not have to be rebuilt for every study. "So you're not recreating the wheel every time you're trying to do a new drug," Auchincloss said. "You have a platform, and now you're just trying one thing after another."

The legislation would also expand point-of-care trials, in which patients receive an experimental drug at their regular doctor's office and are monitored through video calls, electronic medical records or wearable devices. Griffith, whose southwest Virginia constituents include residents seeking treatment for black lung disease, said many live two hours or more 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.

The bill directs as much as $75 million in annual funding to the FDA over five years and creates a Center for Clinical Trial Innovation at the agency, with the goal of cutting trial costs and enrollment time by at least 30%. It also directs the FDA's Rare Disease Innovation Hub to consult with drugmakers on their concerns. Rare and chronic diseases would be prioritized.

It comes a week after the FDA announced its Rare Disease Framework Initiative, under which the agency said it will be more flexible in evaluating therapies for small patient populations. Former FDA Commissioner Scott Gottlieb said the plan would give drugmakers "very clear rules of the road that are going to last a long time."

Point-of-care trials are not new. The Department of Veterans Affairs ran the first one in 2010, comparing diabetes treatments, and the model is widely used in Australia but has gained little traction in the United States. The bill would also allow natural history databases built from electronic health records to serve as control groups, an alternative to placebos that are often impractical or unethical for rare diseases.

There are limits to the approach. Mark McClellan of Duke University's Duke-Margolis Institute for Health Policy, which helped craft the legislation, said intensive treatments such as gene therapies will still need academic medical centers, though advances such as in vivo gene editing can let patients leave hospital the same day and be monitored at home. "The idea is to make it as easy as possible for the patient to stay right where they are," he said.

Griffith said the bill is unlikely to reach a vote until next year, while Auchincloss's office said it is working with a bipartisan group of senators on a companion measure later this year. Auchincloss said the bill appeals across the political spectrum, from drugmakers and patient groups to followers of the health-focused MAHA movement who want greater access to experimental treatments. "There's something in here for everyone to like," he said.

Analysis

Why This Matters

Rare diseases often affect only a few dozen patients, making recruitment the hardest part of any trial. The bill directly targets that barrier.
Cheaper, faster trials could bring treatments to market sooner and at lower cost, benefiting both drugmakers and patients.
The bill extends the FDA's Rare Disease Framework Initiative into statute, signalling a broader shift in how regulators and Congress want rare disease research to run.

Background

Clinical trials in the United States have traditionally been centralized: patients travel to designated sites, and when a study ends the infrastructure is dismantled. For rare diseases, small patient populations make recruitment slow, and giving placebos can be impractical or unethical. The point-of-care model, treating and monitoring patients in their own communities, was pioneered by the Veterans Affairs department in 2010 and is now widely used in Australia, but it has struggled to take hold in the US. Sponsors point to the network the Cystic Fibrosis Foundation built in the 1990s as proof the approach can work at scale.

Key Perspectives

Rep. Jake Auchincloss (D-Mass.): Says reusable trial platforms let researchers test one drug after another without rebuilding infrastructure, and argues the bill has broad appeal across the political spectrum. Rep. Morgan Griffith (R-Va.): Wants trials brought to patients in rural areas like his southwest Virginia district, where travel to trial centers can take two hours or more. Mark McClellan, Duke-Margolis Institute: Helped craft the legislation and says remote monitoring can keep patients in their own communities while still generating the follow-up data trials need. Skeptics and limits: The approach cannot apply to everything. Complex therapies such as gene therapies will still require academic medical centers, and point-of-care trials have spent over a decade struggling to gain traction in the US despite success abroad.

What to Watch

A Senate companion bill, which Auchincloss's office says is being prepared for later this year.
The timing of a House vote, which Griffith expects no sooner than next year.
How the FDA's Rare Disease Innovation Hub uses its new authority to consult with drugmakers.

Sources

New bipartisan bill aims to speed up clinical trials for rare disease treatments · US Top News and Analysis

Checked

12 claims in this story checked against 1 source: 7 supported.

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Partly supportedThe bill would move rare-disease clinical trials to patients’ local doctors.US Top News and Analysis: “The bill creates a scenario where patients may get an experimental drug in their regular doctor’s office instead of traveling to a clinical trial site.”
Partly supportedLawmakers introduced the bill this week.US Top News and Analysis: “The bipartisan bill, which will be introduced today by Democratic Rep. Jake Auchincloss and Republican Rep. Morgan Griffith”
Partly supportedThe bill targets cuts of 30% in trial costs and enrollment time.US Top News and Analysis: “The goal is to cut the cost of trials and the time it takes to enroll participants by at least 30%.”
SupportedThe bill directs up to $75 million a year to the FDA over five years.US Top News and Analysis: “The legislation directs as much as $75 million in annual funding to the FDA over the next five years.”
SupportedAuchincloss said, “So you're not recreating the wheel every time you're trying to do a new drug,”US Top News and Analysis: ““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.”
SupportedAuchincloss said, “You have a platform, and now you're just trying one thing after another.”US Top News and Analysis: ““You have a platform, and now you’re just trying one thing after another.””
SupportedGriffith said, “We're trying to bring the clinical trial to the patient instead of the model today of bringing the patient to the clinical trial,”US Top News and Analysis: ““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.”
SupportedGottlieb said the plan would give drugmakers “very clear rules of the road that are going to last a long time.”US Top News and Analysis: “The FDA’s plan will give drugmakers “very clear rules of the road that are going to last a long time,” former FDA Commissioner Scott Gottlieb said in an interview on CNBC’s Squawk Box on Oct. 19.”
SupportedMcClellan said, “The idea is to make it as easy as possible for the patient to stay right where they are,”US Top News and Analysis: ““The idea is to make it as easy as possible for the patient to stay right where they are,” said Mark McClellan, founding director of the Duke-Margolis Institute for Health Policy at Duke University, which helped craft the legislation.”
SupportedAuchincloss said, “There's something in here for everyone to like,”US Top News and Analysis: ““There’s something in here for everyone to like,” Auchincloss said.”
Partly supportedPatients receive experimental drugs at their regular doctor’s office and are monitored through video calls, records or wearable devices.US Top News and Analysis: “The bill creates a scenario where patients may get an experimental drug in their regular doctor’s office instead of traveling to a clinical trial site. Trial researchers could track their progress through Zoom calls, electronic medical records or wearable technology.”
Partly supportedGriffith said many constituents live two hours or more from trial centers and are seeking treatment for black lung disease.US Top News and Analysis: “Griffith said the bill would benefit patients beyond those with rare diseases, including residents of his southwest Virginia district who want to participate in studies of new treatments for black lung disease. Some of his constituents live a two-hour drive or longer from medical centers that typically host clinical trials.”