A bipartisan bill introduced by Reps. Jake Auchincloss and Morgan Griffith aims to speed up clinical trials for rare disease treatments. 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 why the FDA suspends clinical trials to avoid delays. Introduced on August 5, 2026, at the US Capitol in Washington, DC, the legislation follows the FDA’s Rare Disease Framework Initiative, unveiled a week earlier, which aims to accelerate approvals for rare disease treatments.
Reimagining Clinical Trial Infrastructure
The bill targets the inefficiencies in the current trial model by establishing a platform for repeated use. Auchincloss stated, “You’re not recreating the wheel every time,” highlighting the need for a standardized framework. This approach aims to streamline processes and reduce redundancy. The legislation creates a “Center for Clinical Trial Innovation” at the FDA to coordinate these networks, drawing parallels to the Cystic Fibrosis Foundation’s pioneering model from the 1990s, which transformed clinical trials for that disease.
The new legislation creates a ‘Center for Clinical Trial Innovation’ at the FDA to coordinate networks of clinical trial sites. The goal is to cut the cost of trials and the time it takes to enroll participants by at least 30%. Former FDA Commissioner Scott Gottlieb praised the FDA’s initiative, stating it provides “very clear rules of the road that are going to last a long time” during a CNBC Squawk Box interview on October 19.
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Bringing Trials to Patients
The legislation promotes “point-of-care” trials, enabling patients to participate from their regular doctor’s office. Remote monitoring tools, such as Zoom, electronic records, and wearables, would replace in-person site visits. This model, already used in Australia and by the Department of Veterans Affairs since 2010, seeks to expand its application, particularly for rare diseases, where patient recruitment and control group formation are challenging.
This model could benefit rare disease patients by expanding access and reducing travel burdens. Griffith pointed out that some constituents face two-hour drives to reach trial sites, showing the need for such changes. The bill also encourages the use of natural history studies, often created by patient families, as control groups instead of placebos, addressing ethical and practical concerns.
It allocates $75 million annually to the FDA over five years to support these initiatives. While the bill won’t reach a vote until next year, Auchincloss expressed confidence in its broad appeal to drugmakers, patient groups, and access advocates. A Senate version is also under development, with bipartisan support expected later this year.
Expanding Access Through Technology
The bill harnesses new technology to bring clinical trials directly to patients. Remote monitoring via Zoom, electronic health records, and wearables allows participants to remain in their regular doctor’s office instead of traveling to trial sites. This approach is particularly beneficial for rare diseases, where patient populations are often geographically dispersed and small in number.
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Addressing Rare Disease Challenges
For rare diseases, the bill provides solutions to common trial obstacles. These studies can be created using electronic health records, further streamlining the process.
While intensive treatments like gene therapies will still require academic medical centers, advancements such as in vivo gene editing enable same-day discharge and remote monitoring. The bill’s $75 million annual funding to the FDA over five years supports these innovations, ensuring that cutting-edge treatments can be studied more efficiently.
Griffith highlighted the bill’s broader impact, noting benefits for patients in his district with black lung disease. Auchincloss stressed its wide appeal, from drugmakers seeking faster, cheaper trials to patient groups advocating for greater access. The legislation’s bipartisan support and broad stakeholder appeal position it as a transformative step in clinical trial innovation.