Clinical Trial Transformation
Projects Relating to Clinical Trial Transformation
Duke-Margolis Faculty & Research Team
Valerie J. Parker, MSc
Assistant Policy Research Director, Regulatory & Real-World Data and Evidence
Events About Clinical Trial Transformation
More EventsEvent 8/27/2026
Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials
Join the Food and Drug Administration (FDA) for a virtual public workshop, convened by the Duke…
Read MoreEvent 4/14/2026
Scaling Innovative Clinical Trial Approaches: Challenges, Progress, and Opportunities
WASHINGTON, DC
This hybrid workshop, co-convened by the Duke-Margolis Institute for Health Policy and the U.S…
Read MoreEvent 11/20/2025
Individualized Therapies on the RISE
WASHINGTON, DC
The current drug development paradigm and associated regulations were developed to test single…
Read MoreEvent 9/3/2025
On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations
WASHINGTON, DC
Conducting clinical trials in rare disease populations continues to pose many unique challenges,…
Read MorePublications About Clinical Trial Transformation
More PublicationsComment Letter
Comment Letter on FDA AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program
Matt D'Ambrosio, Patrick Rodriguez, Alissa Wong, Nora Emmott, Valerie J. Parker, Rachele Hendricks-Sturrup
Matt D'Ambrosio, Patrick Rodriguez, Alissa Wong, Nora Emmott, Valerie J. Parker, Rachele Hendricks-Sturrup
2026
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From Research to Care: Modernizing U.S. Clinical Trial Infrastructure
Valerie J. Parker, Brian Canter, Patrick Rodriguez, Marianne Hamilton Lopez, Mark McClellan
Valerie J. Parker, Brian Canter, Patrick Rodriguez, Marianne Hamilton Lopez, Mark McClellan
2026
Read MoreTopics Related to Clinical Trial Transformation
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Real-World Evidence
As thought leaders in RWE, Duke-Margolis engages public and private stakeholders in this burgeoning…