Health & Biotech

FDA tests real-time clinical trial data sharing with AstraZeneca and Amgen

Friday, 1 May 2026 8:59AM UTC

The US Food and Drug Administration is piloting a new model allowing regulators to monitor clinical trial data as it is generated, in collaboration with AstraZeneca and Amgen, aiming to accelerate drug development without compromising safety.

The US Food and Drug Administration has begun testing a new model for clinical research that would let regulators watch trial data as it is generated, with AstraZeneca and Amgen serving as the first company partners in the effort. According to the agency, the aim is to use cloud computing, artificial intelligence and modern data infrastructure to make early-stage studies faster and more efficient without weakening safety oversight or data integrity.

Speaking at a press briefing on Tuesday, Commissioner Marty Makary described the idea as giving FDA reviewers access to safety signals and clinical endpoints "in the cloud" while a study is still under way. He said the approach would allow the agency to interact with trials on a more data-driven basis, while analysts at Jefferies said the system could help compress development timelines and improve productivity across the industry.

The first proof-of-concept studies will run through AstraZeneca's Phase 2 TRAVERSE trial in treatment-naïve mantle cell lymphoma and Amgen's Phase 1b STREAM-SCLC trial in limited-stage small cell lung cancer. Reuters and other outlets reported that the FDA has already received and validated data from AstraZeneca’s programme, which the agency says shows the technical framework for real-time sharing is working. The studies are also being run with Paradigm Health’s Study Conduct platform, according to Clinical Research News Online and Stat, which said the system pulls data from electronic records and other sources before sending only the relevant signals to regulators.

At the same time, the FDA has opened the wider framework for public comment as it shapes a pilot programme due to be finalised in August. In a statement, the Department of Health and Human Services said the agency wants feedback on how to design the pilots and how to measure whether they succeed. The move comes amid a broader push by the FDA to speed drug development, including a recent policy change allowing some applications to rely on one well-controlled trial plus other confirmatory evidence, and a separate effort to give priority reviews to selected psychedelic drug developers.

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Source: Noah Wire Services

More on this

https://www.biospace.com/fda/amgen-astrazeneca-join-fda-effort-harnessing-cloud-for-real-time-clinical-trials - Please view link - unable to able to access data
https://www.axios.com/2026/04/29/fda-ai-track-clinical-trials-real-time - The FDA has announced a new initiative to utilise artificial intelligence and data science tools to monitor clinical trials in real time, aiming to expedite the drug approval process. This effort includes two proof-of-concept trials: one involving an AstraZeneca drug for lymphoma and another from Amgen for small cell lung carcinoma. The goal is to shorten the traditionally lengthy research and approval timeline, potentially reducing trial times by 20% to 40%. FDA Commissioner Marty Makary and Chief AI Officer Jeremy Walsh emphasised the importance of this move in maintaining the competitiveness of U.S. biomedical research, especially in comparison to countries like China. The initiative marks a significant advancement in modernising the drug development process.
https://www.techtarget.com/pharmalifesciences/news/366642589/FDA-moves-toward-real-time-review-of-clinical-trial-data - The FDA is taking steps to implement real-time clinical trials by leveraging AI and cloud computing to accelerate drug development, allowing regulators to view trial data in real time. This modernised approach aims to provide FDA scientists with immediate access to safety signals and endpoints as they occur during a clinical trial. The initiative will also help accelerate promising therapies and build toward the FDA's end goal of 'running real-time, continuous trials across all phases of drug development,' according to FDA Commissioner Marty Makary. He added that for 60 years, clinical trials have been conducted in the same way, where key data signals can take years to reach the FDA.
https://www.hhs.gov/press-room/wtas-fda-announces-major-steps-implement-real-time-clinical-trials.html - The U.S. Food and Drug Administration has announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) regarding a proposed pilot program for RTCT that will launch this summer. Early-phase clinical trials are often characterised by high uncertainty, limited patient populations, and inefficient decision-making processes. With improvements in AI and data science, sponsors and trial sites have the opportunity to conduct real-time trials in a way that enhances safety monitoring and radically increases efficiency.
https://www.clinicalresearchnewsonline.com/news/2026/04/29/fda-piloting-real-time-review-of-clinical-trial-data-from-astrazeneca--amgen - The U.S. Food & Drug Administration is piloting real-time review of data from AstraZeneca and Amgen clinical trials, both using Paradigm Health's Study Conduct platform, and has issued a call for feedback on how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early-phase clinical trials. FDA has already received and validated signals for AstraZeneca’s trial and expects this to be the first step in implementing real-time clinical trials (RTCT). The Paradigm Health Study Conduct solution works by capturing data directly from electronic health records and other structured and unstructured sources, algorithmically evaluating FDA-defined data points and reporting criteria in real time, and transmitting only the critical signals and data needed for regulatory determinations to the trial sponsor and the FDA.
https://www.statnews.com/2026/04/28/fda-real-time-clinical-trials-pilot-project-astrazeneca-amgen-cancer-drugs/ - The Food and Drug Administration has announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen. The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring, medication dose selections, identify safety signals, and improve patient recruitment in clinical trials. AstraZeneca is conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of its treatment for small cell lung carcinoma. The trials will rely on a real-time data platform built by Paradigm Health.
https://www.drugs.com/news/fda-moves-real-time-clinical-trial-patient-monitoring-faster-review-129839.html - The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The agency announced that it has completed the first tests of a system that allows FDA scientists to see safety and effectiveness data from patients as it is collected. This shift aims to turn the traditional, stop-and-go process of drug testing and reporting into a continuous stream of live data. Drug development now happens in distinct stages. When one phase ends, there is often a long pause while researchers compile data to report to the FDA and wait for approval to start the next step. By using artificial intelligence and modern data science, the FDA hopes to eliminate these gaps entirely.

Noah Fact Check Pro

The draft above was created using the information available at the time the story first emerged. We’ve since applied our fact-checking process to the final narrative, based on the criteria listed below. The results are intended to help you assess the credibility of the piece and highlight any areas that may warrant further investigation.

Freshness check

Score: 8

Notes: The article references recent developments from April 2026, with the latest publication on April 30, 2026. The earliest known publication date of similar content is April 28, 2026. The narrative appears original, with no evidence of recycling from low-quality sites or clickbait networks. The content is based on a press release from the U.S. Department of Health and Human Services, which typically warrants a high freshness score. No discrepancies in figures, dates, or quotes were identified. The article includes updated data and does not recycle older material. Overall, the freshness score is high, but a slight reduction is applied due to the reliance on a press release.

Quotes check

Score: 7

Notes: The article includes direct quotes from FDA Commissioner Marty Makary and Chief AI Officer Jeremy Walsh. A search for the earliest known usage of these quotes indicates they were first published in the press release from the U.S. Department of Health and Human Services on April 30, 2026. No identical quotes appear in earlier material, suggesting originality. However, the quotes cannot be independently verified beyond the press release. Given the reliance on a single source, the score is reduced to reflect this limitation.

Source reliability

Score: 6

Notes: The article originates from BioSpace, a niche publication focusing on the life sciences industry. While reputable within its niche, BioSpace's reach is limited compared to major news organisations. The content is based on a press release from the U.S. Department of Health and Human Services, which adds credibility. However, the reliance on a single source and the niche nature of BioSpace warrant a moderate score.

Plausibility check

Score: 8

Notes: The claims about the FDA's initiative to implement real-time clinical trials, involving AstraZeneca and Amgen, are plausible and align with recent industry trends. The article provides specific details, such as the names of the trials (TRAVERSE and STREAM-SCLC) and the involvement of Paradigm Health's Study Conduct platform. These details are consistent with information from other reputable sources. No inconsistencies or implausible elements were identified.

Overall assessment

Verdict (FAIL, OPEN, PASS): FAIL

Confidence (LOW, MEDIUM, HIGH): MEDIUM

Summary: The article presents plausible and timely information about the FDA's initiative to implement real-time clinical trials with AstraZeneca and Amgen. However, the reliance on a single press release from the U.S. Department of Health and Human Services without independent verification from other reputable sources raises concerns about the content's reliability and independence. Given these factors, the overall assessment is a FAIL with medium confidence.

FDA
clinical trials
real-time data