Washington's Clinical Trial Alphabet Soup

By Dan Schell, Chief Editor, Clinical Leader

I’ll admit it. Like many Clinical Leader readers, I find it difficult to keep track of all the legislative proposals and federal initiatives coming out of Washington that have something to do with clinical trials. It seems like every few weeks there’s another announcement promising to make trials faster, less expensive, more accessible to patients, or easier for sponsors and sites to conduct.

Of course, those are all worthwhile goals. And anyone who has worked in clinical research long enough knows we have plenty of room for improvement. But keeping track of who’s proposing what, which initiatives overlap, and whether any of them will actually change the way trials are conducted is becoming … well, for me, a real challenge.

Part of my confusion is that not everything coming out of Washington is legislation. Some proposals require congressional approval and funding, while others are FDA regulatory initiatives, pilot programs, or research projects funded by other federal agencies. They also vary considerably in how far they’ve progressed.

So, I thought it might be useful to put together a chronological rundown of some of the significant federal clinical trial initiatives that have emerged in 2026, with a brief explanation of what each is intended to accomplish. But just to make sure I didn’t forget anything — and to make sure I understood everything correctly — I asked Anthony Corso, VP of public policy at Veeva Systems, to “check my work.” (Side note: I was supposed to interview Anthony on stage at the recent Veeva R&D & Quality Summit, but I had to back out due to the fact that, evidently, I’m getting old and my freaking ankle swelled up like a balloon after I did basically nothing to it! Sorry, I digress.)

Overall, Corso sees potential in these legislative efforts, provided the infrastructure can support them. “This is real progress for the industry and, most importantly, for patients,” he said. “But, trial networks and decentralized models only work with modern, standardized technology underneath them, so data moves easily and participation is simple for patients. Technology is the enabler that makes the rest of this possible.”

April 2026: Clinical Trial Modernization And Real-Time Data

April 28 — FDA’s Real-Time Clinical Trials Initiative

The FDA announced progress on its Real-Time Clinical Trials (RTCT) initiative, including two proof-of-concept studies involving AstraZeneca and Amgen. The goal is to allow clinical trial endpoints and other data signals to be transmitted to the agency in real time, potentially allowing regulators and sponsors to identify safety concerns and make development decisions more quickly.

The FDA also issued a request for information about a broader pilot program. The initiative is intended to address the delays associated with collecting, analyzing, and submitting clinical trial data through conventional processes. Whether real-time reporting will meaningfully shorten development timelines remains to be demonstrated.

April 29 — Clinical Trial Modernization Act (S. 4440)

Sens. Tim Scott (R-SC) and Mark Warner (D-VA) introduced bipartisan legislation intended to reduce financial and logistical barriers that prevent patients from participating in clinical trials.

The bill addresses issues associated with participant support and the financial implications of research participation. Its broader objective is to make trials more accessible, particularly to patients who might otherwise be excluded because of economic circumstances.

The legislation was referred to the Senate Finance Committee. As with any proposed bill, its provisions would need to be enacted before becoming law.

June And July 2026: TrialBlazer, Access, And Participant Compensation

June 8 — Right To Try For Individualized Treatments Act (H.R. 9190)

Introduced by Reps. Diana Harshbarger (R-TN) and Andy Biggs (R-AZ), this legislation would expand access to certain investigational individualized treatments for patients with life-threatening diseases or severely debilitating illnesses. Although this is not specifically a clinical trial modernization bill, it is relevant to the broader discussion about access to investigational therapies. It also raises questions about how expanded-access pathways interact with conventional clinical research and the generation of evidence needed for regulatory approval.

The legislation was referred to the House Energy and Commerce Committee.

June 22 — HHS Launches Operation TrialBlazer

HHS announced Operation TrialBlazer on June 22 as a department-wide effort to accelerate clinical research, strengthen U.S. trial infrastructure, and address barriers to conducting studies. It is not a single FDA program. The FDA’s September Expedited IND pilot and subsequent actions on clinical development are components of the broader HHS initiative.

FDA actions under the initiative include revised draft guidance on master protocols and clarification of when one adequate and well-controlled pivotal trial, together with confirmatory evidence, may support approval. The effort also extends beyond FDA to questions of participant support and health information exchange.

HHS’s Office of Inspector General has requested input on whether anti-kickback safe harbors or beneficiary-inducement exceptions should be modified to accommodate appropriate clinical trial participant payments, such as transportation, childcare, or stipends. The request is exploratory, not a final rule, and complements the separate tax questions raised by S. 5127.

The Office of the National Coordinator for Health Information Technology (ONC) has also signaled possible EHR certification requirements connecting EHR systems with ClinicalTrials.gov. That remains a potential interoperability measure rather than a finalized requirement.

July 23 — Harley Jacobsen Clinical Trial Participant Income Exemption Act (S. 5127)

This bipartisan bill, introduced by Sens. Jim Banks (R-IN) and Catherine Cortez Masto (D-NV), addresses a problem that doesn’t always receive much attention: the financial consequences of participating in clinical research. Under current federal tax rules, compensation for clinical trial participation is generally taxable income. However, effective January 1, 2026, the IRS reporting threshold for certain payments increased from $600 to $2,000 annually. That means organizations generally must issue a Form 1099-MISC when reportable payments to a participant reach $2,000 in a calendar year. Importantly, this is a reporting threshold, not a tax exemption. Payments below that amount can still be taxable.

The Harley Jacobsen legislation would go considerably further by excluding qualifying clinical trial compensation and certain expense reimbursements from federal taxable income altogether. It would also prevent those payments from being counted when determining eligibility for certain government assistance programs. For patients concerned that participating in research could increase their taxes or jeopardize their benefits, that distinction could be significant. This isn’t Congress’s first attempt to address the issue. In June 2025, Reps. Mike Kelly (R-PA) and Chrissy Houlahan (D-PA) introduced H.R. 4184, which also proposed excluding certain clinical trial compensation from taxable income.

It’s a particularly interesting issue because the industry spends considerable time discussing how to recruit more diverse patient populations, yet the financial consequences of participating in a trial can be a barrier for the very patients sponsors hope to reach. The 2026 Senate bill was referred to the Finance Committee.

September 2026: Accelerating Trial Startup And Rethinking Trial Design

September 15 — FDA’s Expedited IND Pilot Program

The FDA launched a pilot program intended to reduce the time between identifying a promising drug candidate and initiating a first-in-human clinical trial. Under the program, participating sponsors can work with qualified research institutions to develop IND submissions more efficiently. The FDA can review certain components of those submissions on a rolling basis rather than waiting for the complete application. The program also encourages better coordination of activities that traditionally occur sequentially, including IND preparation, IRB review, and clinical trial site activation.

Applications for the Expedited IND pilot, one component of HHS’s broader Operation TrialBlazer, were being accepted through October 30, 2026. For sponsors and sites, the interesting question will be whether the approach actually eliminates delays or simply requires organizations to perform more activities simultaneously.

September 30 — ARPA-H Launches SURPASS

The Advanced Research Projects Agency for Health (ARPA-H), an agency within HHS modeled after the Defense Advanced Research Projects Agency (DARPA), announced Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS).

SURPASS seeks to fundamentally change how clinical trials are designed and conducted through computational modeling, digital twins, continuous statistical analysis, adaptive designs, and automation. Its objectives include reducing development timelines, lowering costs, and decreasing the number of participants required to generate reliable evidence. Unlike FDA’s RTCT initiative, which emphasizes real-time reporting of trial information to regulators, SURPASS focuses on developing new trial methodologies and supporting technologies. Examples include digital twins to simulate trial outcomes before launch, adaptive platform designs with shared control groups, continuous statistical analysis, and AI-enabled tools to automate trial startup and data processing.

ARPA-H also announced three complementary projects: STACK, which targets site activation and enrollment; COMMONS, which focuses on data infrastructure; and CINCH, which addresses patient engagement and access to research. These are R&D efforts, not new regulatory requirements. Their eventual impact will depend on whether the technologies can be validated and adopted by sponsors, sites, and regulators.

October 2026: New Congressional Legislation

October 22 — Faster Clinical Trials Act (H.R. 10857)

On October 22, Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA) introduced the bipartisan Faster Clinical Trials Act, a proposal that could have significant implications for how and where clinical research is conducted. The legislation would establish a Center for Clinical Trial Innovation within FDA’s CDER. One of its responsibilities would be supporting site networks that could conduct multiple trials without repeatedly rebuilding their infrastructure.

The bill calls for establishing at least three clinical trial networks within one year of enactment, prioritizing community health centers, rural clinics, and other healthcare settings that have historically lacked the resources to conduct clinical research. It also proposes reducing duplicative regulatory processes, improving the integration of health records and research systems, supporting innovative trial designs, and addressing common causes of clinical holds.

One of the more interesting aspects of the proposal is its emphasis on integrating clinical trials into routine healthcare. That’s a concept the industry has discussed for years, but the bill would attempt to establish federal infrastructure to support it.

Of course, creating a network is one thing. Staffing sites, training physicians, supporting coordinators, integrating technology, and sustaining research operations are quite another. Those practical challenges will determine whether an initiative like this can succeed. Also, according to Corso, “A Senate companion to this Act is expected, but the text is still evolving, aka, not yet introduced. I wouldn't expect it until next year.”

Plenty Of Activity, But What Will Actually Change?

Looking at these initiatives together, it’s encouraging to see that Washington is paying attention to problems the clinical research industry has been discussing for years. Patient access, trial startup delays, regulatory complexity, fragmented data, and the costs associated with conducting research are hardly new concerns.

What’s less clear is how these various efforts will work together. For example, the FDA is pursuing real-time clinical trial data reporting while ARPA-H is funding technologies designed to enable continuous, adaptive trials. Meanwhile, Congress is proposing new clinical trial networks, and ARPA-H is also investing in technologies to activate additional research sites. There are obvious areas of overlap, but that doesn’t necessarily mean the programs are being coordinated. And although several initiatives promise to make trials faster and less expensive, those benefits haven’t yet been demonstrated across the clinical research enterprise.

For those of us following ClinOps, the important questions are fairly straightforward:

• Will these initiatives reduce the work required of research sites?
• Will sponsors and CROs see meaningful improvements in startup timelines and trial execution?
• Will patients find it easier to participate in studies without taking on additional financial or logistical burdens?

Those are the outcomes worth watching as these proposals move forward. In the meantime, I’ll keep trying to keep all the acronyms straight.