Formats

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.

Recent News Feed

CTTI to Launch New Recommendations on Disease Progression Modeling in Free Public Webinar 

CTTI News | June 10, 2025

Topics Included: Innovative Trials

The Clinical Trials Transformation Initiative (CTTI) will host a free public webinar on Tuesday, July 8, to introduce new recommendations for using disease progression modeling (DPM) to improve medical product development. 

The webinar will include a welcome from Sara Calvert, CTTI director of projects; a keynote presentation from Cynthia J. (CJ) Musante, vice president of scientific research at Pfizer; a project overview from Lindsay Kehoe, CTTI senior project manager; and a panel discussion moderated by Kehoe featuring perspectives on the potential real-world application and impact of the recommendations. Panelists include Karthik Venkatakrishnan from EMD Serono, Tiffany Westrich-Robertson from AiArthritis, Theo Zanos from Northwell Health, and Efthymios Manolis from the European Medicines Agency. 

A disease progression model is a mathematical model that quantitatively describes the time course or trajectory of a disease. By integrating multi-disciplinary knowledge and data from different sources—including translational, clinical trial, and real-world data—DPM can improve trial design, answer questions of uncertainty, and support regulatory decisions. 

CTTI’s new recommendations aim to guide medical product development decision makers—such as clinical, regulatory, and innovation leaders—in identifying when DPM can offer unique value, what foundational elements are required, and how to communicate effectively with modeling experts to support its implementation. 

The 60-minute webinar will begin at 12:00 PM EDT. To attend, please take a moment to register.  

We encourage you to share this announcement with colleagues or others in your network who may be interested in attending.

Recent News Feed

Inside the State of Clinical Trials: Perspectives, Problems, and Pathways Forward 

CTTI News | June 9, 2025

Topics Included:

The Clinical Trials Transformation Initiative (CTTI) convened 150 clinical trials leaders, patients, policy influencers, and trialists in Washington, D.C., on May 22 for a dynamic meeting focused on the state of clinical trials. The agenda centered on problem solving—identifying core tensions preventing transformative change across the enterprise and workshopping actionable solutions.  

Dynamic presenters set the stage for the day with reflections on “where are we now?” in clinical trials ahead of targeted workshops. Speakers included former FDA commissioner Dr. Rob Califf, Donna Cryer from the Global Liver Institute, Ken Getz from the Tufts Center on the Study of Drug Development, Brad Hirsch of Highlander Health, Esther Krofah from The Milken Institute, and Ramita Tandon from Walgreens.   

Attendees discussed the five areas of CTTI’s Transforming Trials 2030 vision in depth in breakout sessions that were deftly facilitated by over 25 leaders in the enterprise.  

“CTTI expertly designed the workshops to make sure there were multiple perspectives represented throughout the day,” said attendee Jane Myles, Program Director at the Decentralized Trials and Research Alliance (DTRA). “Our discussions tackled tough topics which really challenged our critical thinking for change in clinical trials.” 

Workshops focused on targeting the most problems in patient centricity, trials in routine settings, quality and efficiency, data availability, and population health. In a workshop discussing privacy and responsible re-use of data, attendees identified data ownership as a critical roadblock. Attendees emerged from workshops eager to implement a federated learning network to solve this problem that includes artificial intelligence (AI) to improve the ease and speed of data sharing.  

“One of our goals for this meeting was to have all attendees really see themselves in the solutions we’re cocreating,” said CTTI Executive Director Morgan Hanger. “Together, we represent the trials enterprise so it’s incumbent upon all of us to drive change within our own corners of the clinical trials ecosystem.”  

CTTI plans to release a detailed summary of the meeting in late June to help engage more people from across the clinical trials enterprise on actionable next steps for this transformation. 

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