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# Stakeholders Comment on AI-Enabled Trial Pilot
- URL: https://www.fdaweb.com/stakeholders-comment-on-ai-enabled-trial-pilot/
- Published: 2026-06-25T12:00:00.000Z
- Updated: 2026-09-14T13:41:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161378

In responding to an FDA Request for Information (RFI) on an AI-enabled optimization of early-phase clinical trials pilot program, the Association of Clinical Research Organizations (ACRO) [makes](https://www.regulations.gov/comment/FDA-2026-N-4390-0159?ref=fdaweb.com) these points:

- contract research organizations are a keystone in building the architecture for real-time, continuous clinical trials;
- the RFI is seen as the beginning of an ongoing, recurring dialog between FDA and industry stakeholders;
- there should be more precision about the use of the term electronic health records;
- the Clinical Trial Modernization Act can help ensure representation among trial participants; and
- support for FDA’s budget proposal to accelerate U.S.-based early-phase clinical trials.

The ACRO comment letter also has specific answers to agency questions posed in the RFI.

In its [response](https://www.regulations.gov/comment/FDA-2026-N-4390-0149?ref=fdaweb.com), the Biotechnology Innovation Organization (BIO) says it commends FDA efforts to streamline clinical trials using novel technologies such as AI. “BIO believes that the success of this pilot program will depend on a carefully scoped and methodologically rigorous approach that enables learning under controlled conditions and supports a deliberate, evidence-based pathway to broader implementation,” the letter says. “BIO recommends that the pilot program be anchored in a focused, safety-oriented framework, with an initial emphasis on early-phase clinical trial settings. These contexts offer a suitable environment for evaluating AI-enabled approaches under conditions of uncertainty while maintaining appropriate safeguards for patient safety and trial integrity.”

In addition to responding specifically to FDA’s questions in the RFI, BIO recommends:

- FDA further clarify its intended definition of “real-time” data access and review;
- there is a need for greater transparency on the AI approaches contemplated for the pilot;
- FDA should set clear governance and risk management expectations to establish transparency, including how the agency would distinguish between AI used as human in-the-loop decision support versus autonomous decision-making, how reproducibility and auditability should be maintained as machine learning systems evolve during development, and what protections would apply to proprietary data incorporated within the AI framework;
- FDA should consider global regulatory alignment and implementation considerations for device-enabled, real-time clinical trials;
- FDA should develop a targeted evaluation plan for the real-time clinical trial pilot; and
- FDA should confirm alignment of the pilot program design including key clarifications that were communicated during a 5/15 FDA industry information session.

The Eli Lilly comment [letter](https://www.regulations.gov/comment/FDA-2026-N-4390-0154?ref=fdaweb.com) gives specific answers to the questions FDA posed in the RFI, noting the company’s significant investments in AI across the full drug development lifecycle, saying it is a core component of Lilly’s scientific strategy.