Happenings

Optimizing Flexibility and Data Quality in Clinical Trials: Bringing Clarity to DIA Global 2025 

CTTI News | June 25, 2025

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At this year’s DIA Global Annual Meeting, Lindsay Kehoe, senior project manager at the Clinical Trials Transformation Initiative, chaired a panel under Track 8 – R&D Quality and Compliance – titled, “Do Flexible Trial Approaches Impede Data Quality? Perception vs. Reality.” 

The panel brought together regulatory, data, and technology experts to explore how clinical trials can be modernized without compromising scientific rigor. Featured speakers included Cheryl Grandinetti of the Food and Drug Administration, Catherine Gregor of Florence Healthcare, and Ken Wiley of the National Institutes of Health. All three are collaborators on CTTI’s new initiative, “Optimizing Data Quality and Flexibility in Clinical Trials.” 

Together, the panelists examined how operational flexibility — such as integrating trials into clinical care, decentralizing data collection, and offering participant choice — can coexist with, and even enhance, data quality when guided by a Quality by Design (QbD) framework. 

Flexibility and data quality are not at odds. Instead, the discussion emphasized that both must be fit for purpose. Flexible approaches are evolving with increasing use, fostering faster recruitment, reduced participant burden, and greater inclusivity. However, to ensure that data remains credible and reliable, and provides evidence of effectiveness and safety for regulatory decision-making, those involved in designing and conducting trials must proactively identify critical-to-quality (CTQ) factors, map data flows, and mitigate risks through thoughtful design and oversight. 

CTTI’s project aims to bring clarity to this intersection by developing tools such as a process document, a map of data “pain points,” and case examples of successful flexible trials. These resources are intended to help sponsors, sites, and regulators align on acceptable data variability and completeness, define tolerable error thresholds, and ensure that trial designs are both patient-centric and scientifically sound. 

Looking ahead, the clinical research community must design studies that meet participant needs for easier involvement, are operationally feasible, and are of sound quality. The key takeaway is that flexibility and data quality are not opposing forces — they are complementary pillars of a modern, inclusive, and efficient clinical trial ecosystem. 

Those leading and supporting clinical trials are encouraged to engage early, plan intentionally, and design with purpose. 

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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.

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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.

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

CTTI News | June 9, 2025

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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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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.

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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

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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.

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