For a few good years now, "clinical trial digitalization" has been more of a promise than a reality. Wearable sensors, monitoring apps, remote data collection — all of it existed technically, but mostly stayed at the stage of isolated pilot projects or theoretical discussions. The real reason behind the bottleneck wasn't technology — it was regulation: without clear rules on how this data should be validated to count officially in a drug approval file, clinical trial sponsors had no real reason to take the risk.

That exact regulatory bottleneck has gradually become FDA's direct target. The US agency responsible for approving drugs has built a dedicated program, step by step: the underlying commitment dates back to 2022, through the PDUFA VII law; the first cycle of direct research funding opened in 2024; and the current funding round, plus a public workshop, are arriving now, in 2026 — a first concrete answer to a question many in the field have been asking for years: when, exactly, will digital technology become a normal part of the clinical testing process?

To understand why this response matters so much, the simplest way is to look at things through the eyes of a patient in a real clinical trial.

A patient enrolled in a clinical trial for a chronic disease would normally have to travel monthly to the research center for a single measurement — an hour of travel, a day off work, sometimes a companion. In 2026, the technology exists to avoid that: a sensor worn at home can transmit the same data automatically, daily instead of monthly. The problem is no longer the technology — it's that the regulator approving drugs hasn't yet established exactly how this data should be validated so it can officially count in an approval file.

1. Where this commitment comes from

Integrating digital technology into clinical trials isn't a spontaneous FDA initiative — it's a commitment taken on through PDUFA VII, the 2022 law that reauthorizes the fees paid by the pharmaceutical industry to the agency. Through this document, FDA committed to developing a dedicated program for digital health technologies (DHTs): wearable devices, sensors, apps capable of collecting clinical data directly from patients, at home.

Since 2022, the program has already produced an official published framework, a dedicated internal committee (DHT Steering Committee), and several real pilot projects already underway. The first cycle of direct research funding on this topic (RFA-FD-24-037) opened in 2024, including for organizations outside the US.

2. The latest wave of moves, from summer 2026

Direct funding for research. On July 20, 2026, FDA opened a new funding round (RFA-FD-26-012) — two grants, each worth up to $1.1 million per year, over a two-year period, for projects testing how digital technologies (actigraphy, photography, contactless sensors) can be used directly within clinical trials for new drugs. The good news: applications are still open — but not for much longer. The deadline is August 20, 2026.

An important distinction between the two cycles: the current grant (2026) is open exclusively to US organizations, unlike the 2024 cycle, which also allowed applicants from outside the US — eligibility rules aren't fixed, they've changed from one cycle to the next and could return to a more open format in future cycles.

A public workshop, open to anyone. Separately from the grant, FDA and the Duke-Margolis Institute for Health Policy are organizing, on August 27, 2026, a free virtual workshop on statistical considerations for "digitally-derived endpoints" — essentially, how data collected through sensors is scientifically validated so it can be used as official evidence. Unlike the grant, this event is public, with no nationality restriction — anyone can register and attend, regardless of country.

3. Not just the US — Europe is aligning too

FDA isn't the only agency moving in this direction. The international good clinical practice guideline, ICH E6(R3), which officially recognizes digital health technologies as acceptable tools in clinical trials, has already taken effect in the European Union (July 23, 2025), Switzerland (August 15, 2025), and the United Kingdom (January 12, 2026) — with the European Medicines Agency (EMA) aligned, through this shared standard, to the same direction as FDA.

In practice, this isn't just an isolated American move — it's a broader convergence among major regulatory agencies toward the same set of expectations regarding digital technology in clinical research.

4. Why it matters, even if you can't apply for current funding

Even if a researcher or organization outside the US can't directly access the 2026 grant, the results of the funded research will eventually become public — and will influence the standards that any clinical trial sponsor, anywhere in the world, will need to follow if they want digital data to be accepted by FDA. The August workshop is, in this sense, more practically relevant: it's a direct window into the regulator's thinking, before final rules are set. And EMA's alignment through ICH E6(R3) shows that the rules that matter for clinical trials in Europe are heading, either way, toward the same place.

FDA isn't promising a sudden change — it's showing, step by step, verifiably, a firm direction, built over several years and now backed by the alignment of European agencies as well. For anyone working in clinical research, the real question is no longer whether this shift will happen, but how prepared they'll be once the rules become mandatory, not just experimental.

Sources:

• U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Digital Health Technologies (DHTs) for Drug Development. https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development

• RFA-FD-26-012, National Institutes of Health Grants Guide. https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-26-012.html

• RFA-FD-24-037 (previous cycle), National Institutes of Health Grants Guide. https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-037.html

• Regulatory Affairs Professionals Society (RAPS). This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more. https://www.raps.org/resource/this-week-at-fda-diamantas-touts-onshoring-efforts-grants-for-dhts-and-more.html

• Workshop registration: https://duke.is/4/7rtf