On April 28, the FDA’s Chief AI Officer, Jeremy Walsh, and former FDA Commissioner Marty Makary announced a major new FDA pilot program aimed at operationalizing real-time clinical trials. In this new pilot initiative, alerts stemming from AI analysis of trial data will flow from sites to the agency continuously rather than arriving only in packaged submissions months or years after the fact. The pilot will start with AstraZeneca’s TRAVERSE study in mantle cell lymphoma and Amgen’s STREAM-SCLC trial in small cell lung cancer. Paradigm Health will be the technology partner for the pilot, serving up the real-time data alerts. The program then aims to expand to a broader group of participants this summer.
If all goes as planned, this initial pilot will begin to shift us away from data arriving at the health authorities in “sedimentary” layers, months or years after the fact, and toward a future paradigm in which there is a continuous flow from trial sites directly to regulators.
At Weave, we see this development as only the first small step of a larger logical progression. If data can flow continuously, the regulatory record must follow suit.
The “static dossier” model — where content is authored, reviewed, and submitted as a frozen PDF — is becoming obsolete. Regulatory teams cannot rely on batch-compiling months of work at a phase’s conclusion if the agency has real-time visibility. Documentation must evolve into a living narrative that mirrors the trial’s progression.
How Former FDA Officials are Reacting: Long Time Coming!
Several members of our network who served previously in key technology roles at the FDA have shared on the promise that they see in this new initiative.
Dr. Amy Abernethy, CEO of Highlander Health (and former FDA CIO and Principal Deputy Commissioner) suggested that this announcement represents significant momentum toward modernization. She noted that moves she made to adopt data standards like JSON and FHIR at the FDA provided the necessary “plumbing” for AI to eventually supercharge these workflows. Crucially, she also warned that “audit features” must be embedded within the data; regulators require absolute confidence that even high-velocity data remains verifiable and traceable.
Dr. Sean Khozin, CEO at the CEO Roundtable on Cancer (and former Associate Director of FDA’s Oncology Center of Excellence) viewed the announcement as a vital renovation of a three-century-old experimental model. Sean described a story he shared with Jeremy Walsh (now FDA’s first Chief AI Officer) regarding the 1747 trial of the HMS Salisbury that gave us the controlled experiment but also burdened us with the notion of the “average patient”. Khozin argued we have long since chased this “statistical phantom” and it’s high time that we leave it behind. By eliminating the latency between data generation and regulatory oversight, he argued, we can finally serve real individual patients, and in real time.
Dr. Tala Fakhouri, Chief AI & Regulatory Strategy Officer at Parexel (and former FDA Associate Director for Policy Analysis) emphasized that the ultimate goals are predictability and accelerated decision-making. Transitioning from theory to practice necessitates a new kind of digital infrastructure. Describing Parexel’s partnership with Paradigm Health, Fakhouri explained how pre-validated infrastructure allows sponsors to align on shared expectations with the FDA upfront.
Weave’s own relationship with Parexel serves as something of a natural complement to their partnership with Paradigm. That is to say, operationalizing real-time trials requires a two-pronged approach: the high-fidelity infrastructure of partners like Paradigm to capture data at the source, and the agentic AI capabilities of Weave to ensure that data is instantly contextualized and woven into a living regulatory record.
One Possible Future: Agentic AI and Project PRISM
A precursor to this future is already taking shape through Weave’s collaboration with FDA PRISM (the PrecisionFDA Regulatory Information Service Module). PRISM is an FDA and industry research collaboration initiative designed to create a secure, cloud-based environment where sponsors and reviewers access the same evidence simultaneously.
Weave has been working with Dr. Vada Perkins, Global Head of Regulatory Intelligence and Policy at Boehringer Ingelheim and Co-PI of the PRISM initiative, to demonstrate how agentic AI can support a globally harmonized regulatory framework. Weave now serves as the AI technology contributor for PRISM, working with PRISM’s industry and technology partners to develop novel AI capabilities in the PRISM environment. In one recent use case we applied our AI platform capabilities to align stability evidence with requirements from the health authorities, surfacing gaps with full traceability. We are now working with our partners in PRISM to develop an AI-enabled Structured Protocol Authoring capability.
Looking toward a next-generation AI-native version of PRISM, we can envision a secure, real-time environment where both sponsors and reviewers interact with the same “living” record. In this future, AI doesn’t just check work; it ensures the regulatory record is perpetually review-ready, structured, and interoperable from day one.
What Comes After the Static Dossier?
The HMS Salisbury trial that Sean Khozin invoked was radical for its time. It gave us the controlled experiment and, with it, the tools to do science at scale. But every paradigm eventually becomes a constraint. The sequential, static model of clinical development served us for decades. What’s becoming clear is that the infrastructure underneath that model — the way data moves, how records are maintained, who sees what and when — no longer has to be the limiting factor.