FDA Advances Implementation of Real-Time Clinical Trials announced two major steps to support the implementation of real-time clinical trials (RTCTs).
First, the agency confirmed the initiation of two proof-of-concept clinical trials designed to report endpoints and data signals to the FDA in real time. Second, the agancy released a Request for Information (RFI) regarding a proposed RTCT pilot program planned for launch in summer 2026.
Objective of Real-Time Clinical Trials
The initiative aims to address challenges associated with early-phase clinical trials, including:
- High uncertainty
- Limited patient populations
- Inefficient decision-making processes
Traditionally, trial data is reported from sites to sponsors before submission to the FDA. The FDA stated that advances in artificial intelligence and data science create opportunities for real-time monitoring and improved operational efficiency.
FDA Perspective
According to the FDA, the current clinical trial model can delay the transmission of important safety signals and endpoints to regulators, potentially slowing regulatory decision-making and product development timelines.
“We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses. 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 FDA Commissioner Marty Makary, M.D., M.P.H.
The agency indicated that real-time access to trial data could support faster evaluation of promising therapies and contribute to the long-term objective of continuous clinical trials across development phases.
Proof-of-Concept Trials
The FDA announced the successful initiation of two RTCT proof-of-concept studies:
AstraZeneca Trial
AstraZeneca is conducting the Phase 2 multi-site TRAVERSE trial in patients with treatment-naïve mantle cell lymphoma.
Participating institutions include:
- The University of Texas MD Anderson Cancer Center
- University of Pennsylvania
Amgen Trial
Amgen is conducting the Phase 1b STREAM-SCLC trial in patients with limited-stage small cell lung carcinoma.
Final site selection for the study is ongoing.
Real-Time Signal Sharing
For both studies, the FDA worked with sponsors to establish criteria for real-time signal reporting.
The agency confirmed that it successfully received and validated signals from AstraZeneca’s trial through Paradigm Health, demonstrating the feasibility of the technical framework for real-time data sharing.
Proposed Pilot Program
The FDA plans to expand these proof-of-concept activities through a broader RTCT pilot program.
The newly issued Request for Information seeks feedback regarding:
- Pilot program design
- Implementation approaches
- Evaluation metrics
- Success criteria
The agency will accept comments on the RFI until May 29, 2026. Final selection criteria are expected in July, with pilot selections anticipated in August 2026.
Continuous Clinical Trial Vision
The FDA noted that clinical development is currently conducted in separate phases, each operating under distinct protocols and study structures.
This model can create pauses between phases, slowing development timelines.
The agency stated that real-time access to trial insights may reduce or eliminate these interruptions, supporting the future implementation of continuous clinical trials.
For more information: FDA Announces Major Steps to Implement Real-Time Clinical Trials
Supporting Clinical Research Processes
The expansion of real-time clinical trial models highlights the growing importance of adaptive clinical operations, efficient data management, and technology-enabled study oversight.
Baupharma’s Clinical Research services support sponsors across clinical trial planning, study management, and operational processes to help align evolving trial models with regulatory and development requirements:
https://www.baupharma.com/services-categories/clinical-research/#Clinical-Research-services
