Happenings

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. 

Recent News Feed

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 worked closely with partners across the clinical trials ecosystem to gather perspectives and expertise that have helped shape this work.

CTTI deeply appreciates these partnerships 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.

Recent News Feed

CTTI Welcomes New Executive Committee Members

CTTI Announces Appointment of Three New Executive Committee Members

CTTI Welcomes New Executive Committee Members

CTTI News | February 12, 2025

Topics Included:

Today, CTTI announces the appointment of three new members to its Executive Committee, which is responsible for making recommendations about the overall direction and strategy for the organization. The new Executive Committee members, whose three-year term runs from 2025-2028, include:

  • Dana Lewis, OpenAPS
  • Stephen Pyke, Parexel
  • Moke Sharma, Bristol Myers Squibb

“CTTI is honored to welcome these three leaders to our Executive Committee,” said Morgan Hanger, CTTI Executive Director. “From their different seats as patient advocates, regulators, and research sponsors, all have truly unique expertise in leveraging innovation to generate and use the evidence that individuals need to make decisions, which is at the heart of our work.”

“The newly appointed Executive Committee members bring a wealth of experience as well as a demonstrated commitment to transformation,” said CTTI Executive Committee Chair Mark McClellan. “We look forward to collaborating with these leaders as they contribute their unique insights to our ongoing efforts to enhance and modernize clinical trials.”

The 19-member Executive Committee includes distinguished U.S. and international thought leaders in academia, government, industry, and patient advocacy who are experienced at envisioning and facilitating improvements in health care and medical research systems. Additionally, CTTI wishes to express sincere gratitude to the following outgoing Executive Committee members for their 20 years of collective service ranging from 2018-2024: Donna R. Cryer, Global Liver Institute; Pat Furlong, Parent Project Muscular Dystrophy; and Steven K. Galson, Boston Consulting Group.

Recent News Feed