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LUGPA Policy Brief: FDA’s Real-Time Clinical Trials Initiative

May 2026

At-a-Glance Essentials

What’s Changing:
The U.S. Food and Drug Administration (FDA) is advancing a real-time clinical trials (RTCT) initiative, including proof-of-concept studies and a Request for Information (RFI) on an AI-enabled pilot program.

Why It Matters:
RTCT models are intended to support more continuous data sharing, improve safety monitoring, and potentially reduce delays in clinical development and regulatory review.

Executive Summary

On April 28, 2026, the FDA announced new efforts to modernize clinical trials through real-time clinical trials (RTCT). Initial initiatives include proof-of-concept studies led by AstraZeneca and Amgen, as well as an RFI seeking stakeholder input on a broader AI-enabled pilot program.

The initiative reflects ongoing efforts to evaluate how real-time data systems and AI-enabled tools could support clinical trial efficiency, safety oversight, and regulatory decision-making. For patients with prostate, bladder, kidney, and other genitourinary conditions, these models may influence how future therapies are studied and reviewed.

Background

Traditional clinical trials often rely on delayed or batch-based data reporting, which can slow regulatory review and development timelines. The FDA’s RTCT approach would enable more continuous data sharing and near-real-time monitoring of safety and efficacy signals.

Initial proof-of-concept studies include:

  • TRAVERSE (AstraZeneca, Phase 2): Mantle cell lymphoma
  • STREAM-SCLC (Amgen, Phase 1b): Limited-stage small cell lung cancer

The FDA’s RFI seeks feedback on pilot design, implementation, safety oversight, and evaluation metrics.

Relevance to Urology and Independent Practices

Independent and community-based urology practices play an important role in clinical research, particularly in genitourinary cancers.

Potential implications include:

  • More streamlined clinical trial operations
  • Expanded use of AI-enabled safety monitoring tools
  • Greater integration of real-time data collection systems
  • Potential expansion of clinical trial participation across community settings

Considerations for Policymakers and Stakeholders

As the initiative develops, stakeholders may consider:

  • Inclusion of independent physician practices in pilot design and implementation
  • Evaluation metrics related to patient access, diversity, safety, and operational impact
  • Use of established AI risk management and privacy frameworks
  • Opportunities to streamline broader clinical trial administration and oversight processes

Conclusion

The FDA’s RTCT initiative represents an evolving approach to clinical trial modernization and regulatory oversight. As these models continue to develop, participation from specialty and community-based practices may help inform how real-time and AI-enabled systems are incorporated into future clinical research frameworks.