Policy Watch: FDA looks to expand real-time drug clinical trials

FDA uses artificial intelligence as it moves to expand ‘real-time’ clinical trials

A pilot program to use artificial intelligence in clinical trials is already underway at the US Food and Drug Administration, the agency announced on Tuesday. The agency is seeking input on expanding the program(PDF).

Pharmaceutical giants AstraZeneca and Amgen are working with the FDA on “real-time clinical trials,” in which data are sent to the FDA as the trial is conducted, rather than after it ends, according to an FDA press release. The trials are testing drugs for lymphoma and lung cancer.

“Real-time trials have been talked about for years,” Jeremy Walsh, the FDA’s chief AI officer, says in the release. “We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem.” He adds, “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.”

It’s possible that such an approach could safely speed up trials, particularly for patients awaiting potentially life-saving drugs, says Erick Turner, a professor emeritus at Oregon Health and Science University who researches study design, publication bias, and FDA standards.

But it could also represent a move to prioritize industry over patients, and it risks “corner cutting,” he says, noting that in February, the FDA moved to make a single clinical trial the standard for drug approvals. “My suspicion is that this is not in the direction of raising the bar.”

It’s unclear how the program will ensure that trial sponsors and researchers have no access to the data before the analysis is complete—a process that prevents unconscious bias from influencing the results.

To ensure accuracy, the FDA and sponsor need to agree on the statistical analysis and outcome thresholds ahead of time, Turner says.

The FDA offered no comment in response to questions about trial design from C&EN; it instead referred to the related Federal Register notice

The trials are being run using a platform developed by the clinical trial tech company Paradigm Health. The platform uses AI to scan electronic health records and transmit data to the trial sponsor and the FDA, according to a press release from Paradigm. The company worked with the FDA to build the platform and define reporting protocols, the release says.

—Laura Dattaro, special to C&EN

Ninth Circuit declines to make the EPA act on organophosphates petition

The US Court of Appeals for the Ninth Circuit on Monday denied a request made by a dozen environment, health, and farmworker organizations represented by Earthjustice to compel the US Environmental Protection Agency to act on their 2021 petition to ban organophosphate pesticides over concerns about neurotoxicity.

After waiting close to 4 years for a response from the EPA, the petitioning organizations filed a writ of mandamus to the Ninth Circuit court in 2025 requesting that the court order the agency to act. But “a four-year delay is below the threshold of what we have generally found to be unreasonable,” the court writes in its memorandum decision (PDF).

While the petitioners were waiting, in 2022, Congress extended a registration review deadline for older pesticides, like the organophosphates included in the petition, until Oct. 1, 2026. The Ninth Circuit factored that into its decision, saying “it is not unreasonable for EPA to delay taking final agency action until the 2026 registration review deadline.”

The EPA has already said, however, that it will not finish its reviews for any of the 13 organophosphate pesticides by then. “If EPA chooses not to address the chemicals posing the greatest risk by the 2026 deadline, Petitioners are free to file a second mandamus petition as to those chemicals,” the court says. The EPA previously banned the use of one of the organophosphates in question, chlorpyrifos, on food crops in 2021. But in 2023, the US Court of Appeals for the Eighth Circuit vacated that ban and sent the issue back to the EPA for reconsideration. That review, along with the others, is ongoing.

—Delger Erdenesanaa

Major FDA study of infant formula chemical contaminants finds few concerns

The vast majority of infant formula products available on the US market have undetectable or very low levels of chemical contaminants, according to results from a study released Wednesday by the US Food and Drug Administration.

As part of Operation Stork Speed, an FDA initiative to ensure the safety and durability of the US infant formula supply, the agency tested 312 infant formula samples from 16 different brands for the presence of arsenic, cadmium, lead, mercury, 30 per- and polyfluoroalkyl substances (PFAS), 318 pesticides, 21 phthalates, and one non-phthalate plasticizer.

Across all samples, which were collected between 2023 and 2025, most contaminants were detected at levels far below US Environmental Protection Agency (EPA) drinking water limits.

Most PFAS and phthalates included in the analysis were not found in any samples, though a minority had levels exceeding EPA thresholds. DEHP, a phthalate commonly used in plastics, was detected in only 19% of samples but was seen at concentrations as high as 57 parts per billion (ppb); the EPA’s legal limit for drinking water is 6 ppb. The FDA said that some samples had contaminant concentrations that initialed further testing and engagement with manufacturers but did not specify the contaminants or manufacturers.

The FDA also tested 110 human milk samples. At least one detectable contaminant was present in 85% of samples—mercury had the highest detection rate, in 61% of samples—though contaminants were overwhelmingly detected at very low concentrations. In its press release announcing the results, the agency emphasized that breast milk “is the optimal source of nutrition for infants whenever possible.”

In response to a request for comment, a Department of Health and Human Services spokesperson said that the FDA “has taken several concrete steps” under Operation Stork Speed to increase testing for spore-forming microbiological contaminants in infant formula, such as Clostridium botulinum and Bacillus cereus.

Thomas Galligan, principal scientist for food additives and supplements at food safety watchdog Center for Science in the Public Interest, said his organization believes “that infant formula and baby food companies should be required to test their products for heavy metals and report those test results to the FDA.” But, he added, “federal laws do not require such testing.”

—Yaakov Zinberg, special to C&EN