Agenda
10:00 – 12:00 PM | Small Group Breakout Discussions
(attendees choose one track; see below for details)
- IRB Reform
- Real-World Data & Real-World Evidence
12:00 – 1:00 PM | Arrivals & Lunch
1:00 – 1:10 PM | Opening Remarks
1:10 – 2:25 PM | The Clinical Trial Abundance Landscape
- The Broken Clinical Trial Operating System
- Surrogate Endpoints
- Phase I Trials
- Trials for Pregnant Women
- Clinical Trial Modernization Act
(group discussion)
Deeper Dives
2:25 – 3:05 PM | IRB Reform
(group discussion)
3:05 – 3:15 PM | Break
3:15 – 3:55 PM | Real-World Evidence
(group discussion)
3:55 – 4:50 PM | Policy Outlets & Next Steps
- Admin Panel (3:55 – 4:20)
- Next Step Speakers & Group Discussion (4:20 – 4:40)
(group discussion)
4:50 – 5:00 PM | Closing Remarks
Breakout Session Details
(10 am to 12 pm)
Using the FDA Sentinel Initiative to Maximize the Value of Real-World Data and Real-World Evidence
Concrete Objective: Develop legislative language to advance three goals for the Sentinel Initiative: (1) expand its use to complement clinical trials and broaden its role in regulatory decisions; (2) add more data sources, including additional EHRs; and (3) make Sentinel more accessible to researchers and the public.
Details: This breakout session will outline 1Day Sooner’s legislative objectives for maximizing the value of real-world data and real-world evidence through the FDA’s Sentinel Initiative. Moderators will lead attendees in a brainstorming exercise on how to achieve these goals, what critiques and questions the proposals may face, how those objections can be addressed, and what alternative or related goals are worth considering.Focus session for the Council’s January 2026 meeting. Exploring how healthy research participants think about the purpose and broader effects of joining medical studies, and how their perspectives can help better describe these wider impacts for future trials. Read the meeting notes.
The Future of IRBs: Investigator Choice, an Open-Source Alternative, Transparency, and AI Support in an Era of Commercial IRBs
Concrete Objectives: Develop regulatory proposals to give federally-supported investigators the right to work with an IRB of their choice; establish an open-source IRB as an alternative to existing independent IRBs; require independent IRBs to publish redacted information about their study reviews; and develop publicly-available AI tools to assist investigators and automate certain regulatory processes.
Details: This breakout session will review efforts to give investigators the right to choose their IRB and consider what that means given how prevalent commercial and other independent IRBs have become. Discussion will then turn to proposals for establishing an open-source IRB, requiring transparency from independent IRBs, and developing AI tools that support investigators and reduce regulatory and administrative burden. Attendees will take part in a brainstorming exercise to weigh the merits and drawbacks of these proposals, consider alternative legislative and policy advocacy goals, and explore other pathways for improving IRB efficiency and effectiveness.
Suggested Readings
Find background information, reform opportunities and recommendations in the briefing book.
Phase 1
- Australia’s Clinical Trial Notification (CTN) Scheme: Therapeutic Goods Administration Overview
- Focus session for the Council’s January 2026 meeting. Exploring how healthy research participants think about the purpose and broader effects of joining medical studies, and how their perspectives can help better describe these wider impacts for future trials. Read the meeting notes.
IRB Reform
Federal Datasets
Decentralized Trials / Platform Trials
- Exemplary platform trials: RECOVERY (2020), HEALEY ALS (2026)
- Exemplary decentralized trial: ACTIV-6 (2024)
- ASCO research statement: Improving Access to Patient-Focused, Decentralized Clinical Trials Requires Streamlined Regulatory Requirements