On June 22, 2026, the US Department of Health and Human Services launched Operation TrialBlazer, a department-wide effort involving FDA, NIH, ARPA-H, and other HHS components aimed at, in HHS’s framing, restoring American leadership in clinical trials and shortening the path from drug discovery to first-in-human testing. As part of that launch, FDA announced two concrete steps toward a Real-Time Clinical Trials (RTCT) program: the successful initiation of two proof-of-concept trials that report data to the agency as it accrues, and a Request for Information (RFI) on a proposed RTCT pilot. FDA has since said it intends to publish final pilot selection criteria in July 2026 and complete pilot selections in August 2026. This post summarizes what is confirmed as of this writing and what remains open.
What “real-time clinical trials” means in FDA’s framing
RTCT is not a new regulatory pathway or a change to existing trial-phase requirements. As FDA has described it, the concept is that a trial reports endpoints and safety/efficacy data signals to the agency continuously, or at much shorter intervals, rather than only at prespecified analysis points or at the end of a study. FDA has tied the initiative specifically to early-phase development, where it says uncertainty around dosing, safety, and efficacy, combined with slow progression decisions between phases, is one of the more persistent bottlenecks in getting a candidate therapy from first-in-human testing to a pivotal trial. The stated aim of the pilot is to evaluate whether AI-enabled technologies can improve the efficiency, speed, and quality of decision-making during early-phase trials specifically — not to replace the underlying Phase 1 trial framework or FDA’s Investigational New Drug (IND) review process.
Operation TrialBlazer: the broader policy context
RTCT sits inside a larger HHS initiative, Operation TrialBlazer, announced the same day. HHS has framed the broader effort as addressing the same set of complaints long raised by sponsors and academic medical centers about US trial timelines and site-activation speed — HHS Secretary Robert F. Kennedy Jr. was quoted in the announcement stating that “America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas.” The department has said the combined set of reforms under this initiative is intended to shorten early-phase trial timelines by as much as a year in some cases, though FDA has not published a methodology for that estimate as of this writing, and it should be read as a policy target rather than a measured outcome.
The two proof-of-concept trials
FDA identified two sponsor-run trials as the initial proof-of-concept work behind RTCT:
- AstraZeneca — TRAVERSE. A Phase 2, multi-site trial in patients with treatment-naïve mantle cell lymphoma, with FDA naming The University of Texas MD Anderson Cancer Center and the University of Pennsylvania among participating sites.
- Amgen — STREAM-SCLC. A Phase 1b trial in patients with limited-stage small cell lung carcinoma.
Both trials are described by FDA as reporting endpoints and data signals to the agency in real time as a design feature, functioning as a working model for what a broader RTCT pilot cohort would be expected to do. FDA has not, as of this writing, published detailed technical specifications (data formats, transmission cadence, or the specific clinical trial data standards involved) for how either trial’s real-time reporting is implemented, so research-administration and clinical-data-management staff evaluating whether a similar design is feasible for their own studies should treat those mechanics as not yet public.
The RFI and the pilot-program timeline
Alongside the two proof-of-concept trials, FDA released a Request for Information seeking public input on the design of a broader RTCT pilot program, open to sponsors more generally rather than limited to the two initial trials. FDA posted a Federal Register notice on May 27, 2026 extending the original comment period through June 29, 2026. Since then, FDA has indicated it intends to:
- publish final selection criteria for the pilot program in July 2026; and
- complete selection of pilot participants in August 2026.
As of this writing, FDA has not published the final selection criteria or named additional pilot participants beyond the two proof-of-concept trials described above. Sponsors and institutions considering whether to apply should watch FDA’s own RTCT and Operation TrialBlazer pages directly, since the criteria that determine eligibility (trial phase, therapeutic area, data-infrastructure readiness, and site capabilities) have not yet been released in final form.
What research administration and clinical trials offices should watch for
Nothing about RTCT changes existing obligations under the Common Rule, ICH E6(R2) Good Clinical Practice, or FDA’s IND regulations under 21 CFR Part 312 — the pilot, as described so far, is a data-reporting and decision-support layer added on top of an early-phase trial, not a substitute regulatory pathway. For a clinical trials office or sponsor considering whether to respond to a future call for pilot applicants, the practical open questions are likely to center on: what data infrastructure and near-real-time reporting capability a site or sponsor would need to demonstrate; whether participation changes registration or reporting duties on ClinicalTrials.gov; and how continuous data transmission to FDA interacts with a trial’s existing safety-monitoring plan and registration and reporting compliance obligations. FDA’s RFI responses, once summarized, and the July selection criteria should clarify most of this; institutions with an interest in applying should not assume eligibility or infrastructure requirements based on the two initial proof-of-concept trials alone, since those were sponsor-designed rather than run against a published pilot standard.
Frequently asked questions
Is the RTCT pilot open for general applications right now?
Not as of this writing. FDA has said it intends to publish final selection criteria in July 2026 and complete pilot selections in August 2026; the two named proof-of-concept trials (AstraZeneca’s TRAVERSE and Amgen’s STREAM-SCLC) predate and inform that process but were not themselves selected through a published pilot application process.
Does RTCT replace or shorten the IND/Phase 1 review process?
No. FDA has described RTCT as a continuous data-reporting and decision-support layer for early-phase trials, aimed at improving how quickly dosing, safety, and progression decisions get made within existing phases — not as a change to the IND application process under 21 CFR Part 312 or to Phase 1/2 requirements themselves.
What is Operation TrialBlazer, and how does it relate to RTCT?
Operation TrialBlazer is the broader, department-wide HHS initiative announced June 22, 2026, involving FDA, NIH, ARPA-H, and other HHS components, aimed at speeding up US clinical trials generally. RTCT is one specific FDA workstream inside that broader initiative, focused on real-time data reporting in early-phase trials.
Where can sponsors and institutions track official updates?
FDA’s own press announcements and industry-guidance pages are the primary source for the final selection criteria and any subsequent call for pilot applicants; secondary industry coverage (regulatory-affairs and clinical-trials trade press) has been tracking the RFI and comment-period timeline closely but final criteria will be published by FDA directly.
Related CASRAI resources
- Clinical Research Administration — the cluster hub covering IRB review, GCP, FDA regulatory pathways, and trial data management.
- Investigational New Drug (IND)
- Phase 1 Trial
- ClinicalTrials.gov
- Adaptive Design in Clinical Trials
- Decentralized Clinical Trials (DCTs)
- Clinical Trial Registration and Reporting Compliance
