Past pandemics exposed significant limitations in the U.S. clinical trials enterprise, including insufficient infrastructure, regulatory hurdles, and challenges with rapid recruitment. Despite a strong research foundation, many sites struggled to respond with the agility and scale needed during a national emergency. 

To prepare for future public health crises—including emerging infectious disease (EID) threats—the U.S. must develop a clear understanding of its clinical trials infrastructure. This includes not only current site capacity but also the ability to rapidly scale capabilities and adapt processes to meet urgent demands. 

Phase 1 of the Watchtower Project seeks to fill this knowledge gap by developing a comprehensive, standardized approach to assess site readiness. Phase 2 will identify opportunities for increased capacity, and inform actions that support faster, more efficient clinical research during emergencies.

Watchtower Project

CTTI aims to: 

• Develop a framework for assessing U.S. clinical trials sites’ capabilities, capacity, and how they change over time. 
• Calculate the current capacity and capabilities of U.S. clinical trials sites involved in inpatient and intensive care research on respiratory emerging infectious diseases. 
• Evaluate the feasibility of creating a comprehensive U.S. site inventory. 

Watchtower aspires to strengthen the U.S. clinical trials enterprise by enabling a more coordinated and proactive response to public health emergencies. This work will result in: 

• Improved visibility into national site capabilities. 
• Increased efficiency in trial start-up and execution during emergencies. 
• Better alignment across collaborators—including regulators, sponsors, sites, and health systems—to enable rapid deployment of therapeutics and vaccines. 
• Enhance national preparedness and resilience through a more agile and scalable clinical trials infrastructure.

CTTI will employ a variety of methods to gather data and expert input, including reviewing past infrastructure mapping projects, interviewing experts, administering surveys, hosting an expert convening, and employing the Delphi Process.

As a part of Project Watchtower, the following outputs will be produced: 

• Peer-reviewed journal manuscript. 
• Standardized framework (with operational definitions) to assess U.S. clinical trials site capacity, capabilities, and changes over time. 
• Test framework for utility and usability. 
• Recommendations for an accreditation process that tracks and records site framework completion in a registry. 
• Estimate of existing U.S. clinical trials sites conducting research on the inpatient, intensive care treatment of respiratory emerging infectious diseases (EIDs). 
• Recommendations for an ongoing U.S. Clinical Trials Site Inventory. 

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.