Advocacy Clinical Trial Abundance

Clinical Trial Abundance

What Do We Mean By Clinical Trial Abundance (CTA)?

Achieving clinical trial abundance means making clinical trials cheaper and more efficient — in other words, reducing the cost of generating health evidence while extracting more value from the evidence we already have. The CTA movement focuses on reforming the clinical trial ecosystem to accelerate medical progress through innovative trial design, greater data generation and transparency, and reduced regulatory burden.

Our program pursues two parallel goals: (1) achieving incremental policy change through legislative vehicles such as the Prescription Drug User Fee Act (PDUFA), as well as regulatory rulemaking and guidance; and (2) building a broader movement to drive transformative change over time.

Our vision for the next ten years is to reshape the FDA of the 21st century as profoundly as the post-thalidomide era reshaped the FDA of the 20th. Our stretch goal: within ten years, grow the value of health evidence generated by 10x, at 1/10th the current average cost. To achieve this, we focus our efforts on:

Making it easier to generate clinical evidence;
Finding pathways to maximize the value of existing evidence; and
Improving ways to predict health outcomes and verifying those predictions in the real world.

1Day Sooner strives to be a helpful partner to all parts of the clinical trial policy ecosystem by supplying information, developing policy, supporting communications, and making connections that facilitate our partners’ legislative, staffing, and funding goals.

Our objectives for PDUFA VIII reauthorization include:

Expanding the FDA Sentinel Initiative to a National Real-World Evidence Platform

Current Issue: FDA’s Sentinel Initiative is one of the world’s most valuable distributed real-world data networks, but its use remains largely limited to FDA safety surveillance. Limited access, incomplete electronic health record coverage, and a narrow regulatory mandate restrict its potential to generate post-market evidence.

Proposal: As part of PDUFA reauthorization, FDA should expand Sentinel by incorporating additional federal electronic health record datasets, improving access for qualified external researchers through appropriate governance, and supporting demonstration projects evaluating the use of Sentinel for post-market effectiveness studies alongside its existing safety functions.

Codifying Proactive Disclosure of FDA Complete Response Letters (CRLs) and Common Technical Documents (CTDs)

Current Issue: Complete Response Letters contain valuable regulatory information that could improve future applications, but historically have remained confidential. Although FDA recently began proactively publishing CRLs, the policy depends on agency discretion and has already proven vulnerable to reversal. The underlying Common Technical Documents — the standardized submission dossiers containing the clinical, nonclinical, and quality data FDA reviewed in reaching its decision — remain almost entirely non-public, limiting outside researchers’, competitors’, and future applicants’ ability to learn from the reasoning behind a rejection.

Proposal: As part of PDUFA reauthorization, Congress should require FDA to proactively publish appropriately redacted Complete Response Letters within a defined timeframe after issuance, and should extend that disclosure obligation to the associated CTDs. The agreement should establish sponsor notification procedures, authorize AI-assisted redaction tools to manage the added volume of CTD material, and clarify that confidential commercial information and trade secrets should be protected through targeted redactions.

Ensure Fair Compensation for Clinical Trial Participants

Current Issue: Many IRBs continue to limit participant compensation because of concerns about undue influence, despite limited evidence that reasonable payment compromises informed consent among adults with decision-making capacity. These practices can make recruitment more difficult and reduce access to research participation.

Proposal: As part of PDUFA reauthorization, FDA should issue guidance clarifying that participant compensation should reflect time, burden, inconvenience, and effort, and that concerns about undue influence should ordinarily be addressed through informed consent rather than payment restrictions. FDA should also encourage IRBs to consider whether compensation is sufficient to support equitable participation.

Increase Transparency in Institutional Review Board (IRB) Decisions

Current Issue: Independent IRBs play a critical role in protecting research participants, yet the reasoning behind their decisions is rarely available to researchers, sponsors, or the public. Limited transparency contributes to inconsistent review standards, unnecessary protocol revisions, and duplication of effort across the clinical research ecosystem.

Proposal: As part of PDUFA reauthorization, FDA should establish a voluntary demonstration program for independent IRBs reviewing FDA-regulated research to publish redacted protocols, IRB-required protocol modifications, and standardized meeting minutes. FDA should also develop a standardized template for documenting IRB deliberations to improve consistency across participating IRBs.

Events

Upcoming Events:

Stay Tuned!

Past Events:

Roundtable Discussion on HHS’s Operation TrialBlazer (Clinical Trial Abundance Seminar Series) Read Summary Report here (July 2026)
Clinical Trial Abundance Symposium 2026 (June 2026) Find the symposiums briefing book here.

Reports, White Papers and other Publications:

Event Summary Reports:

Summary Report: Roundtable Discussion on HHS’s Operation TrialBlazer (Clinical Trial Abundance Seminar Series) (July 2026)

Other Publications:

“The Bipartisan, Bicameral Clinical Trial Modernization Act Would Help Eliminate Cost and Geographic Barriers to Clinical Trials  ” signed by 1Day Sooner and nearly 200 patient, public health and health care professional groups (July 2026)
“The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn’t It?” by Josh Morrison (June 2026)
“Implementing AI-Assisted Transparency Initiatives at the FDA” by Ben Snyder and Alastair Fraser-Urquhart (February 2026)
“Mandatory Publication of FDA Complete Response Letters with AI-Assisted Redaction” by Ben Snyder and Taylor Livelli (October 2025)
“From Strategy to Impact: Establishing an AI Corps to Accelerate HHS Transformation” by Enlli Lewis (December 2024)
“Slow Aging, Extend Healthy Life: New incentives to lower the late-life disease burden through the discovery, validation, and approval of biomarkers and surrogate endpoints” by Raiany Romanni & Enlli Lewis & Josh Morrison (December 2024)
“Unblocking Human Challenge Trials For Faster Progress” by Alastair Fraser-Urquhart and Josh Morrison (October 2024)
“Fair Pay: Legalizing Comprehensive Compensation In Clinical Trials” by Jake Eberts and Allison Foss (October 2024)
“Improving Regulator Capacity Through Artificial Intelligence” by Enlli Lewis (October 2024)

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