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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

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

Transforming Trials 2030

CTTI Vision for Clinical Trials in 2030

CTTI envisions a future where clinical trials are more efficient, inclusive, and impactful by 2030—setting a shared aspiration for everyone in the research ecosystem. While progress may unfold at different paces across regions, populations, therapeutic areas, and trial types, this vision serves as both a roadmap and a call to action. To support this effort, CTTI launched the Measuring Trials Transformation project, developing a streamlined Metrics Framework and identifying high-priority metrics to track progress toward trial transformation.

Guided by this vision, CTTI is shaping its priorities, encouraging widespread adoption of forward-thinking practices, and collaborating with individuals and organizations to drive meaningful advancements. 

While our vision applies broadly to clinical trials, CTTI’s efforts primarily align with the NIH definition—research studies that prospectively assign participants to one or more interventions (which may include placebos or controls) to evaluate their effects on health-related biomedical or behavioral outcomes. However, we anticipate that our work will also benefit other clinical studies, including those without prospective assignment. Recognizing that clinical trials exist within the broader landscape of evidence generation, we remain committed to fostering progress that enhances the accessibility, quality, and relevance of research worldwide. 

By 2030, clinical trials need to be:

patient centered and easily accessible

fully integrated into health processes

designed with a quality approach

maximally leveraging all available data

improving population health

A Critical Part of the Evidence Generating System

CTTI Projects

The need for better, more efficient clinical trials has never been clearer. CTTI unites experts from across the clinical trials enterprise—including clinicians, ethics board representatives, healthcare system leaders, patients, payors, regulators, and sponsors—to identify challenges, exchange ideas, and develop actionable solutions. Through a collaborative, research-driven approach, CTTI creates evidence-based recommendations and tools that drive real change. These solutions are designed to enhance the quality and efficiency of trials today while advancing a bold vision for the future: Transforming Trials 2030.

 

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

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.

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DIA Global Annual Meeting 2025

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DIA Global Annual Meeting 2025

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Clinical Trials Landscape

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 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.

CTTI Announces Appointment of Three New Executive Committee Members

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.

Regeneron Pharmaceuticals

this is teh excerpt for the spotlight space

Transforming Trials 2030

this is an excerpt made for transforming trials 2030

CTTI Projects

this is the excerpt for the CTTI projects page.

Safety

Ensuring the safety and protection of our study participants is without question the highest priority of any research endeavor, and at CTTI, we understand the complexities involved. Thoroughly and...

Topics

Safety

Ensuring the safety and protection of our study participants is without question the highest priority of any research endeavor, and at CTTI, we understand the complexities involved. Thoroughly and efficiently incorporating human research protection goes beyond risk mitigation; it demands timely and accurate safety data reporting, appropriate IRB and informed consent practices, and continuous communication with data monitoring committees.

CTTI's patient safety resources provide comprehensive solutions, featuring practical tips, best practices, and expert guidelines to help you navigate these complexities.

Key Materials

CTTI Recommendations: IND Safety Assessment and Communication

CTTI Recommendations: Data Monitoring Committees

CTTI Recommendations: Informed Consent

Topic Resources

CTTI News

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

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...
Events

Bioethics International & EY 2025 Roundtable: Ethics, Trust + Patient Centricity in Pharma – Defining Metrics for Success

Establishing a Global Industry Reporting Standard for Clinical Research Data: Public health, ethics, and business considerations in response to Declaration of Helsinki
Events

DIA Global Annual Meeting 2025

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Events

DIA Global Annual Meeting 2025

Building Upon Quality by design and Risk-based Monitoring Implementation Momentum
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...
CTTI News

CTTI Announces Appointment of Three New Executive Committee Members

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.

Regeneron Pharmaceuticals

this is teh excerpt for the spotlight space

Transforming Trials 2030

this is an excerpt made for transforming trials 2030

CTTI Projects

this is the excerpt for the CTTI projects page.

Safety

Ensuring the safety and protection of our study participants is without question the highest priority of any research endeavor, and at CTTI, we understand the complexities involved. Thoroughly and efficiently...

DHT sub topics

Formats

CTTI Project

Stage of Trial