Pilot on Real-Time Clinical Trials

The U.S. Food and Drug Administration (FDA) announced major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCTs). In particular, the agency released a Request for Information (RFI) regarding a proposed pilot program that will launch this summer. Comments must be submitted by 29 June 2026.

AI-Enabled Optimization of Early-Phase Clinical Trials

Early-phase clinical trials are a bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision-making processes. Data is typically reported from sites to sponsors, who analyze and subsequently submit data to the FDA. Therefore, the pilot program aims to explore how advances in artificial intelligence (AI) and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions.

Furthermore, real-time clinical trials (RTCTs) are a key step toward the agency’s goal of enabling continuous trials. Today, most clinical development proceeds in distinct phases. Because each phase is conducted under its own protocol—typically as a separate study—there is often a gap between the end of one phase and the start of the next. This slows the pace of product development. By allowing the FDA to review critical information as it emerges, real-time trials could eliminate these gaps or reduce them to a minimum, enabling "continuous" trials.

The agency intends to disseminate final selection criteria in July and complete pilot selections in August. More information is available under AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.