Assessing U.S. Clinical Trials Site Capacity and Readiness for Public Health Emergencies​

July 30-31, 2025

CTTI Project: Watchtower

MEETING OBJECTIVE:

  • Gather perspectives on what information should be included in a framework to assess site capacity and capabilities to support a coordinated response to future public health emergencies.

Meeting Location:

Virtual

Meeting Materials:

Meeting Agenda
Meeting Summary
Presentation Set Day 1
Presentation Set Day 2

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

The State of Clinical Trials: Charting the Path to 2030

MAY 22, 2025

CTTI Project: State of Clinical Trials

Meeting Objectives:

  • Create shared understanding of how the clinical trials enterprise is performing
  • Advance solutions to catalyze trial efficiency, in line with CTTI’s Transforming Trials 2030 vision
  • Identify individual and collective actions to ensure a thriving trials enterprise moving forward

Meeting Location:

The Westin Downtown Washington, D.C.

Meeting Materials:

Meeting Agenda

List of meeting attendees

Full Presentation Set

Executive Summary

 

The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

New CTTI Project Aims to Develop Framework for Assessing U.S. Clinical Trial Site Capacity and Readiness for Public Health Emergencies

CTTI News | June 17, 2025

Topics Included: Clinical Trials Landscape

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.

Watchtower

Topics Included: Clinical Trials Landscape

CTTI’s Watchtower Project addresses growing concerns about the readiness and capacity of U.S. clinical trials sites to generate timely and impactful clinical evidence, particularly during public health emergencies (PHEs). As recent crises have demonstrated, a robust, responsive, and coordinated clinical trials infrastructure is critical for rapid evaluation and emergency use authorization of vaccines and therapeutics. 

To support this need, Watchtower proposes to assess and estimate U.S. clinical trials site capacity, including sites’ ability to expand and adapt during emergencies. This initiative aims to develop a framework to evaluate readiness, identify gaps, and offer scalable solutions that enhance national preparedness for future emergencies.

Resources

Site Planning | Expert Meetings

Assessing U.S. Clinical Trials Site Capacity and Readiness for Public Health Emergencies​

View materials from the July 2025 expert meeting.

Clinical Trials Landscape | Expert Meetings

The State of Clinical Trials: Charting the Path to 2030

On May 22, 2025, CTTI convened 150 clinical trials leaders, patients, policy influencers, and trialists in Washington, D.C., for a dynamic meeting focused on the state of clinical trials.

Clinical Trials Landscape | CTTI News

New CTTI Project Aims to Develop Framework for Assessing U.S. Clinical Trial Site Capacity and Readiness for Public Health Emergencies

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...

Clinical Trials Landscape

Watchtower

CTTI’s Watchtower Project addresses growing concerns about the readiness and capacity of U.S. clinical trials sites to generate timely and impactful clinical evidence, particularly during public health emergencies (PHEs).

Clinical Trials Landscape | CTTI News

Measuring Trials Transformation (MTT) Project Update: Tracking Progress Toward Transforming Clinical Trials

In September 2023, CTTI launched the Measuring Trials Transformation (MTT) Project to track progress toward CTTI’s Transforming Trials 2030 (TT2030) vision. Introduced in 2021, this vision outlines how clinical trials...

Clinical Trials Landscape | Poster Presentations

The State of the Oncology Clinical Trials Portfolio: Insights from ClinicalTrials.gov

SCT Annual Meeting CTTI Project: State of Clinical Trials Download Presentation (785.09 KB)

Clinical Trials Landscape | Poster Presentations

Preparing the Study Dataset from ClinicalTrials.Gov for analysis using disease conditions to re-group trials by clinical speciality

ACRT/SCTS/AFMR Joint Annual Meeting CTTI Project: State of Clinical Trials Download Presentation (785.09 KB)

Clinical Trials Landscape | Poster Presentations

The State of Clinical Trials in Rheumatology: A review of the clinicaltrials.gov dataset

ACR/ARHP Annual Meeting CTTI Project: State of Clinical Trials Download Presentation (785.09 KB)

Clinical Trials Landscape | Poster Presentations

The State of Infectious Disease Clinical Trials: A Systematic Analysis of ClinicalTrials.gov

IDSA Annual Meeting CTTI Project: State of Clinical Trials Download Presentation (785.09 KB)

Clinical Trials Landscape | Poster Presentations

State of Diabetes-Related Trials in the ClinicalTrials.gov Dataset

EASD Annual Meeting CTTI Project: State of Clinical Trials Download Presentation (785.09 KB)

Formats

Stage of Trial

Measuring Trials Transformation (MTT) Project Update: Tracking Progress Toward Transforming Clinical Trials

CTTI News | March 20, 2025

Topics Included: Clinical Trials Landscape

In September 2023, CTTI launched the Measuring Trials Transformation (MTT) Project to track progress toward CTTI’s Transforming Trials 2030 (TT2030) vision. Introduced in 2021, this vision outlines how clinical trials should evolve by 2030 to become more efficient and inclusive, focusing on five key pillars: patient-centeredness, integration with health processes, trials designed with a quality approach, data-driven approaches, and improving population health. To measure progress toward these goals, the MTT project created the Metrics Framework, a parsimonious set of metrics that correspond to key domains of progress within each of the TT2030 pillars. This framework is designed to assess the transformation of clinical trials by creating specific benchmarks for understanding the state of clinical trials both today and in the future.  

Since its launch, CTTI’s Measuring Trials Transformation team has made significant progress in refining the Metrics Framework by reviewing more than 100 public comments and incorporating feedback to improve the set of metrics. From the broader Framework, the team identified nine high-priority metrics to focus on for data collection and analysis. The team is currently analyzing original trial documentation from CTTI’s AACT database of Phase 3 interventional trials conducted at U.S. sites between 2018 and 2024 to be able to answer key metrics.

Kelly Avery, MTT Project Team Leader and Operations Administrator for Research at Mayo Clinic, said, “The MTT project at CTTI is focused on moving us into the future. We’re striving to truly understand the ‘state of clinical trials, and to do that, we must first establish a baseline. By creating this baseline, we’ll gain the clarity needed to guide our next steps and drive meaningful progress.”

To support the successful execution of the project, CTTI has partnered with ClinConnect, a patient advocacy platform with valuable expertise in clinical trial analysis. ClinConnect developed best-in-class technology to manage and promote a searchable database for patients and caregivers, making it simple and straightforward for everyone to understand the totality of their clinical trial options.   

Robert Maxwell, Founder of ClinConnect, highlighted the value of the collaboration, saying, “Working with the MTT team has been a highly rewarding experience. We’re aligned on the key challenges and moved by the progress we’ve made. The ClinConnect team thrives when we’re given the freedom and trust to address these issues head-on, and the MTT team has been excellent here. We look forward to continuing this collaboration and making a lasting impact for patients worldwide.”  

CTTI deeply appreciates ClinConnect’s partnership and the invaluable insights they have shared, which have been instrumental in driving the success of this project. CTTI also extends our appreciation to the MTT Project Team, whose ongoing dedication and expertise are essential to the success of this effort. 

Looking ahead, CTTI plans to release the full Metrics Framework and initial findings on our website. These findings will serve as an important reference for discussions at the inaugural State of Clinical Trials: Charting the Path Forward meeting on May 22, 2025 

CTTI is eager to continue this vital work and engage in meaningful conversations that will help shape the future of clinical trials.