In recent years, concerns have been raised about the limited real-time awareness of U.S. clinical trial sites’ capacity and capabilities, including their ability to support a coordinated and effective response to public health emergencies (PHEs).

To address these gaps, CTTI has launched Project Watchtower, an initiative aimed at developing scalable strategies to evaluate and strengthen clinical trial site infrastructure and readiness across the United States.  

Through Watchtower, CTTI will define site capability and capacity benchmarks, assess the feasibility of a standardized site readiness evaluation, and identify methods to unlock additional research capacity. This includes addressing regulatory burdens, streamlining startup processes, and ensuring equitable patient recruitment, particularly in time-sensitive situations.  

To inform this work, CTTI will review past infrastructure mapping projects, engage experts through interviews and surveys, and convene expert meetings to share insights and shape recommendations. A modified Delphi process will also be used to reach consensus on framework content. 

The anticipated outputs of the project include a peer-reviewed manuscript outlining a standardized framework for assessing site capacity, capabilities and changes over time, as well as an estimate of existing U.S. clinical trial site capacity for inpatient, intensive care research on respiratory emerging infectious diseases. In addition, the project will include recommendations for establishing an ongoing U.S. clinical trial site inventory to support future coordinated responses. 

Through these efforts, Watchtower supports CTTI’s Transforming Trials 2030 vision by advancing a more agile, coordinated and equitable clinical trial enterprise that is equipped to meet urgent national health needs.