A Message from CTTI's Executive Committee Co-Chairs
Dear Colleagues,
As we reflect on the past year, each of us brings a unique perspective to the Clinical Trials Transformation Initiative (CTTI). Together, as the CTTI Chairs, each representing different perspectives on the clinical trials enterprise, we are excited about the tremendous opportunities ahead. While we come from varied backgrounds, we share a common enthusiasm for the advancements we're making and the potential for even more impactful progress ahead.
The need for more and better evidence remains urgent, especially as we work to implement new and innovative trial approaches. Implementing these changes is challenging, but crucial, as we push the boundaries of what clinical trials can achieve. CTTI is dedicated to catalyzing and guiding this evolution, helping to bridge the gap between innovative ideas and practical execution.
CTTI is also a key player in assimilating flexible regulatory guidance, helping trial sponsors and researchers adopt new methods and while maintaining rigor. Our role is to inspire ongoing innovation, encouraging everyone in the clinical trials ecosystem to continue experimenting, iterating, and refining new approaches. The work ahead is complex, but by embracing change, we can make trials more efficient and innovative.
We would like to express our sincere appreciation to our members. Your dedication to developing CTTI's resources and bringing change into your own organizations has been instrumental. We are excited to continue this journey with you, including at our inaugural State of Clinical Trials meeting in May 2025, where we look forward to tackling challenges and sharing insights together.
Thank you for your ongoing support and collaboration.
Mark B McClellan, MD, PhD
Chair
Robert J. Margolis Professor of Business, Medicine, and Policy
Director, Duke-Margolis Center for Health Policy, Duke University
John Alexander, MD, MHS, FACC
Co-Chair
Cardiologist and Professor of Medicine, Department of Medicine
Director of Cardiovascular Research, Duke Clinical Research Institute, Duke University
M. Khair ElZarrad, PhD, MPH
Co-Chair
Deputy Director of the Office of Medical Policy at the Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Join Us in Washington, D.C. at the State of Clinical Trials Meeting, May 22, 2025
In 2025, CTTI will host an inaugural State of Clinical Trials meeting for approximately 200 clinical trials leaders, policymakers, and select member representatives. The purpose is to foster honest, solution-oriented conversations about how we can improve efficiency in clinical trials. Efficiency is paramount as we think about how the trials enterprise will keep pace with the rapid innovations in biology and artificial intelligence that will need to be evaluated.
The State of Clinical Trials meeting will feature roundtable discussions so that thought leaders and implementers can identify core solutions in areas of insufficient progress. Topics will draw from the Measuring Trials Transformation work, landscape scans of related evidence gathering, and active engagement with CTTI's Executive Committee, the FDA, members, and other key informants.
Thank you to our outgoing
Executive Committee Members
"Serving as a member of the CTTI executive committee has been so rewarding because of the unique scale, scope, and reach of the organization and our members. Every aspect of my personal and professional experience can be applied for impact on the healthcare of today and tomorrow."
Donna Cryer, outgoing CTTI Executive Committee Member
Donna Cryer, JD
Donna is the founder and CEO of the Global Liver Institute, the leading patient advocacy organization in liver health, working with over 200 organizations in 70 countries. A Harvard and Georgetown Law graduate, she serves on multiple boards and is a recognized expert in digital health, equitable care, and patient engagement.
Pat Furlong
Pat is the founding president and CEO of Parent Project Muscular Dystrophy (PPMD), the largest U.S. nonprofit focused on ending Duchenne muscular dystrophy through advocacy, education, and research. After her two sons were diagnosed with Duchenne, she co-founded PPMD in 1994 and has since been recognized as a top leader in rare disease advocacy.
Steven K. Galson, MD, MPH
Steven is a senior advisor to Boston Consulting Group and serves on the boards of Biocryst Pharmaceuticals and Elephas Biosciences. With over 20 years in government service, including as acting U.S. Surgeon General, he previously held senior roles at Amgen and led regulatory affairs at the FDA's Center for Drug Evaluation and Research.