Real-time data sharing introduced in early-phase trials

The FDA has taken a significant step in advancing implementation of real-time clinical trials (RTCT).

The agency has announced two proof-of-concept clinical trials designed to transmit safety signals and endpoint data in real time to regulators, marking an early step toward a more continuous clinical development model. The FDA also issued a Request for Information (RFI) to inform a broader pilot program intended to expand the use of real-time clinical trial (RTCT) methodologies.¹

“For 60 years, we've been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline,” said FDA Commissioner Marty Makary, MD, MPH, in a press release.¹ “We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses. This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.”

Clinical development has traditionally relied on sequential data collection and periodic reporting, in which trial sites submit data to sponsors, followed by sponsor-led analyses and regulatory filings. This model can introduce delays in safety monitoring and endpoint evaluation, particularly in early-phase studies where uncertainty is high and patient populations are limited.²

The FDA’s RTCT initiative seeks to address these inefficiencies by enabling near real-time visibility into trial data streams.

Proof-of-concept studies from AstraZeneca and Amgen

According to the agency, the newly launched proof-of-concept studies are sponsored by AstraZeneca and Amgen. AstraZeneca’s Phase 2 TRAVERSE trial is evaluating the Bruton’s tyrosine kinase inhibitor Calquence (acalabrutinib) plus AbbVie and Roche's BCL-2 inhibitor Venclexta (venetoclax) and the anti-CD20 antibody rituximab in treatment-naïve mantle cell lymphoma across multiple sites, including The University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen’s Phase 1b STREAM-SCLC trial is investigating the bispecific T-cell engager Imdelltra (tarlatamab) in patients with limited-stage small cell lung cancer, with site selection ongoing.¹

For both studies, the FDA worked with sponsors to define criteria for real-time signal reporting. The agency reported that it has already received and validated data signals from AstraZeneca’s trial through a digital infrastructure platform, supporting the technical feasibility of continuous data transmission.¹

While detailed protocol designs and endpoints for these studies have not yet been publicly disclosed, the initiative represents a shift toward integrating regulatory oversight earlier and more dynamically into trial conduct.

Alignment with digital and decentralized trial trends

The concept of real-time data capture and monitoring aligns with broader efforts to modernize clinical trials through digital technologies, including electronic health records, remote monitoring tools, and artificial intelligence (AI)-driven analytics.³ These approaches have been explored in decentralized and adaptive trial designs, which aim to improve efficiency, reduce patient burden, and enhance data quality. However, widespread adoption has been limited by operational, regulatory, and data standardization challenges.⁴

The FDA’s RFI signals an intent to address these barriers by soliciting stakeholder input on pilot program design, implementation strategies, and evaluation metrics. The agency indicated that feedback will inform selection criteria to be released in July 2026, with pilot participants expected to be finalized in August.

Toward continuous clinical development models

A central objective of the RTCT initiative is to support the development of “continuous trials,” in which transitions between traditional clinical phases are streamlined or eliminated. Currently, clinical development programs often experience pauses between phases due to protocol redesign, data analysis, and regulatory review.

These gaps can extend development timelines and delay patient access to investigational therapies.² By enabling regulators to assess safety and efficacy signals as they emerge, real-time data sharing could reduce these interruptions and facilitate more adaptive decision-making.

Despite its potential, the RTCT model raises several considerations for clinical operations. Continuous data flow may require new infrastructure for data integration, real-time analytics, and secure information exchange. It may also necessitate updated regulatory frameworks to define how interim data are interpreted and acted upon, particularly in early-phase studies where signals may be preliminary.⁴ Additionally, ensuring data quality, interoperability, and patient privacy will be critical to scaling this approach.

Next steps for pilot program development

The FDA has positioned the current proof-of-concept trials as an initial step in evaluating the feasibility of RTCTs within existing regulatory structures. The agency is accepting public comments on the RFI through May 29, 2026.¹

As digital capabilities continue to evolve, the RTCT initiative reflects a broader shift toward more responsive and data-driven clinical development models. Whether these approaches can be operationalized at scale will depend on stakeholder collaboration, technological readiness, and the establishment of clear regulatory guidance.

References

1. US Food and Drug Administration. FDA announces proof-of-concept real-time clinical trials and request for information on pilot program. April 2026.
2. U.S. Food and Drug Administration. Drug development process. Updated 2023. Accessed April 29, 2026.
3. U.S. Food and Drug Administration. Digital health technologies for drug development guidance. 2023.
4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6(R1): guideline for good clinical practice. 2016.