CTTI News

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

CTTI News | June 25, 2025

Topics Included:

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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Patient Engagement Collaborative Announces Eight New Members

CTTI News | December 11, 2024

Topics Included: Patient Engagement

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 caregivers, patients, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communications, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.

The eight new representatives are:

  • Bernard Coley
  • Lisa Craine
  • Rebecca Esparza
  • Syreen Goulmamine
  • Heather Guidone
  • Carter Hemion
  • Toni Jaudon
  • Mary Anne Meskis

The representatives were selected from 75 applications received in response to a Federal Register notice published in July 2024. These new members of the PEC include caregivers who have personal experience supporting someone with a health condition, patients who have personal disease experience, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included FDA staff from multiple centers, CTTI staff and several outgoing PEC members, worked to identify individuals with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.

The PEC, a collaboration established by the FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. The FDA and CTTI collaborate to involve representatives with a variety of perspectives including caregivers, patients, and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Public Engagement Staff, which is responsible for communicating, educating, and engaging with external partners including academia, caregivers, consumers, health care providers, patients, and trade associations on the agency’s policy priorities.

Going forward, the PEC will continue the dialogue around how patient perspectives can inform the clinical trials enterprise and provide information and resources to enhance PEC members’ knowledge about the FDA and CTTI activities to share with patient communities. Previous topics have included: increasing awareness of existing engagement mechanisms among patients and patient groups; increasing patients’ education to empower them to act as representatives of their broader community; enhancing communication between the FDA and patient communities; and promoting global collaboration of patient organizations.

The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years:

  • Kim Hindery
  • Yasmin Ibrahim
  • Seth Morgan
  • Cara O’Neill
  • Ceciel Rooker
  • Christina Sisti
  • Trina Stelly
  • Lauren Youngborg

Since 2008, CTTI has included patient advocates on its Executive Committee, Steering Committee, and project teams and, today, nearly all of its more than 30 sets of evidence-based recommendations and associated frameworks and tools mention inclusion of patients as a critical part of the clinical trials process.

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Holiday Greetings from CTTI: Celebrating a Year of Progress

CTTI News | December 10, 2024

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As 2024 draws to a close, we reflect on a busy year of collaboration at the Clinical Trials Transformation Initiative (CTTI). Thanks to your shared commitment to advancing clinical research, we have developed critical new resources to assist with registration and reporting of clinical trials as well as assessing the ability to embed trial elements into clinical practice.

To showcase these achievements and more, we are thrilled to share our first-ever digital annual report, Modernizing Trials Together. This interactive report celebrates the resources we published in 2024 and highlights our collective impact on the clinical trials landscape.

At CTTI, we believe that actionable solutions underpin meaningful behavior change. That’s why in 2024 we focused on creating foundational tools and assessments like the Embedding Trials Feasibility Survey and the ClinicalTrials.gov report that empower stakeholders to improve processes.

Equally important, though, is our role as a connector in the clinical trials community. Through events like our new CTTI Dinners, panel discussions, public workshops, and Steering Committee meetings, we have fostered open dialogue among industry leaders, patients, regulatory agencies, and researchers. These gatherings are more than just opportunities to meet colleagues — they are the building blocks of future collaborations to make clinical research more impactful, inclusive and practical.

Looking to 2025, we are energized by the biological, computational, and technological advances that are redefining what’s possible in medical product development. CTTI will continue to anticipate the corresponding needs on the clinical development side — ensuring we have the tools for efficient, high quality clinical trials.

We wish you a joyful holiday season and a healthy, productive year ahead.

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New CTTI Project Aims to Identify Challenges and Solutions to Strengthen Proportionate Enrollment in Clinical Trials 

CTTI News | December 3, 2024

Topics Included: Access to Clinical Trials

In December 2024, CTTI launched the Collective Strategies to Enhance Proportionate Enrollment project to improve communication, accountability and clarity across clinical trial partner groups. The project focuses on addressing persistent challenges that hinder the enrollment and retention of participants who reflect the populations most affected by the disease under study. 

Through this effort, CTTI aims to foster unified, action-focused collaboration among sponsors, contract research organizations, sites, patient organizations and other key groups involved in clinical research. By strengthening coordination and aligning expectations, the project will help identify practical strategies to improve how trials are planned and executed. 

To inform this work, CTTI is gathering evidence through qualitative methods, including interviews with individuals involved in clinical trial operations, to better understand group-specific needs and challenges. These insights will shape a set of recommendations and tools that clarify roles, outline implementation considerations and support proportionate enrollment across the trial lifecycle. 

Ultimately, this project will support the generation of high-quality, reliable data and the development of medical products that are safe and effective for all populations. These efforts align with CTTI’s Transforming Trials 2030 vision to create a more efficient, patient-centered and representative clinical trial enterprise. 

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CTTI Leads Discussion on Digital Health Trials at ETH Digital Biomarkers Summit

CTTI News | November 27, 2024

Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning

In November 2024, Lindsay Kehoe, senior project manager at CTTI, presented at the Digital Biomarkers Summit held at ETH Zurich. The event gathered experts from academia, healthcare, and industry to discuss the transformative potential of wearable technologies in healthcare. Among the many topics covered, a key focus was the translation of digital innovations, such as wearable devices for sweat and breath, into clinical implementation to revolutionize healthcare. Digital technologies enable real-time, continuous monitoring of patient data, providing researchers and healthcare providers with deeper insights into patient health, improving trial design, and enhancing data accuracy.

In her workshop, Setting Up Digital Health Trials, Kehoe offered actionable insights on designing successful, fit-for-purpose digital health trials. She outlined key benefits, such as improving trial efficiency, fostering patient-centric research, and ensuring more reliable data. Kehoe also addressed common questions and challenges in implementing digital health trials and shared practical solutions for overcoming them. A central theme of her talk was the importance of communication and collaboration, emphasizing that “collaboration is key to bringing cutting-edge innovation into trials, addressing unmet needs, and improving trial efficiency.”

Dr. Jörg Goldhahn, a CTTI member and Professor at ETH Zurich, echoed Kehoe’s point, noting, “New technology offers great potential for novel biomarkers that can be used remotely, closer to ground truth, and on a continuous basis. However, intensive interprofessional collaboration is required to take these technologies from proof-of-concept into clinical use.”

Kehoe also discussed the importance of equipping researchers with the right tools and resources to successfully implement digital health strategies. She introduced essential resources from CTTI’s Digital Health Trials Hub, designed to guide researchers through key aspects of trial design, including selecting measures and appropriate technologies, managing data securely, developing novel endpoints, and collaborating effectively with clinical sites, patients, and regulators for seamless trial execution.

A notable example of how CTTI’s Digital Health Trials Recommendations are being put into practice is at ETH Zurich, where the institution has integrated these recommendations into its Digital Trial Intervention Platform within the Translational Science Advanced Studies program. This platform enhances the flexibility and scalability of clinical research and aims to optimize digital clinical study designs. These initiatives underscore the real-world impact of CTTI’s resources, demonstrating how we can take digital tools from bench to bedside and drive innovation in clinical research.

For those interested in seeing how CTTI’s resources are being applied in other research settings, the Case Study Exchange offers a range of real-world examples, showcasing how different organizations are integrating innovative tools and approaches into clinical trials.

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