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Turning Watch Readings Into Evidence for New Drugs: FDA Solicits Proposals to Validate Digital Clinical Endpoints
The U.S. FDA is seeking clinically interpretable digital measurement methods through a cooperative research program, with the aim of bringing wearable devices and contactless sensors into drug trials; however, the scale of the two awards also shows that this remains an early-stage effort to establish evidence standards.
In clinical trials, can activity levels recorded by a watch or changes in breathing captured by a room sensor become reliable evidence for determining whether a drug is effective, just like pulmonary function or scale scores? Through a new round of research funding, the U.S. Food and Drug Administration (FDA) is seeking to narrow the gap between everyday digital signals and clinical endpoints acceptable for regulatory use.
The program, numbered RFA-FD-26-012, opened for applications on July 20 and closes on August 20, using the U01 cooperative agreement mechanism. According to official information, two studies are expected to receive funding of up to $1.1 million each, with no matching funds required from applicants; universities, nonprofit organizations, companies, local governments, and tribal organizations, among others, are eligible.
The digital health technologies described by the FDA are not limited to wearable devices, but also include imaging, activity monitors, and contactless sensors placed in the environment. These tools can collect data continuously or frequently in participants’ homes, reducing the burden of travel to trial sites and potentially capturing transient or gradual changes that conventional outpatient examinations can easily miss.
One focus of the solicitation is to directly compare digital measurements with established clinical trial methods and determine whether they indicate the same disease state or treatment effect. Studies may also explore how to analyze continuous data, such as maximum activity capacity and endurance, or establish new clinically meaningful endpoints. Scenarios cited by the FDA include using room sensors to record sleep apnea in children and using tests of balance, reaction speed, and other functions to identify early non-memory manifestations of dementia.
The real challenge is not merely whether sensors can produce accurate readings, but what changes in those numbers mean for patients. Differences between devices, adherence to wearing them, missing data, algorithm updates, and interference from home environments can all affect measurements. Even when a statistically significant change appears, it must still be demonstrated that the change reflects meaningful clinical outcomes such as how patients feel, function, or survive.
Accordingly, this funding opportunity does not constitute FDA endorsement of any specific device or digital endpoint, and no selected studies, disease areas, or validation results have yet been provided. With only two planned awards, the initiative is more akin to using concrete cases to establish methods for comparison and evaluation; only if the research can clearly explain how digital signals translate into credible evidence of drug efficacy might it further influence the design of future drug and biologic trials.