Developments in efforts to advance real‑time clinical trials (RTCT), including the launch of two proof‑of‑concept studies and the release of a Request for Information (RFI) for a pilot program planned for this summer, have been announced by the US Food and Drug Administration (FDA).
The FDA described real‑time trials as a potential way to address longstanding delays in early‑phase drug development, where data typically moves from trial sites to sponsors and then to the FDA before regulators can review it.
According to the regulator, advancements in data science and artificial intelligence (AI) now make it possible for trial sites and sponsors to share key safety and efficacy signals with the FDA as they occur.
FDA Commissioner Marty Makary, MD, said in the agency press release that the current approach to clinical trials has changed little over several decades and that real‑time data access could shorten regulatory timelines.
“This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development, said Commissioner Makary.
Proof-of-concept studies
In its press release, the FDA announced that pharmaceutical giants AstraZeneca and Amgen have begun the first RTCT proof‑of‑concept studies under the new framework.
AstraZeneca is executing a Phase 2 trial, known as TRAVERSE, in patients with treatment‑naïve mantle cell lymphoma at MD Anderson Cancer Center and the University of Pennsylvania.
Amgen is initiating a Phase 1b study, STREAM‑SCLC, in patients with limited‑stage small cell lung cancer, with final site selection underway.
For AstraZeneca’s trial, the FDA reported that it has already received and validated real‑time data signals through Paradigm Health, which the agency said demonstrates the feasibility of the technical infrastructure required for RTCT.
Kent Thoelke, founder and CEO of Paradigm Health, said in a statement that “regulators, sponsors, and providers can have a continuous view of safety and efficacy. By modernizing the flow of information from sites to sponsors to regulators, we have an opportunity to accelerate the delivery of innovative therapies to patients across the country.”
Request for information
The newly issued RFI seeks public input on the design, implementation, and evaluation criteria for a broader pilot program.
Jeremy Walsh, the FDA’s chief AI officer, said the early trials show that real‑time data sharing is achievable and may offer benefits for clinical research operations.
“Real-time trials have been talked about for years. We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem,” said Walsh. “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.”
According to the FDA, real‑time trials could help reduce or eliminate pauses between traditional clinical phases, potentially accelerating product development.
Comments on the RFI will be accepted until May 29, 2026, with final selection criteria expected in July and pilot participants to be chosen in August.