Adoption of Decentralization: Are Our Perceptions Holding Us Back?
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CTTI’s Embedding Trials Feasibility Tool Launch
CTTI Project: Embedding Clinical Trials into Clinical Practice
Webinar Presenters:
- Suanna Bruinooge, ASCO
- Sara Calvert, CTTI
- Lindsay Kehoe, CTTI
- Daniel Larsen, AbbVie
- Denise Snyder, Duke University
- Henry Wei, Regeneron
Webinar Resources:
Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results on ClinicalTrials.gov
CTTI Project: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements
Webinar Presenters:
- Sara Calvert, CTTI
- Carrie Dykes, University of Rochester
- Kelly Franzetti, CTTI
- Elisa Golfinopoulos, NIH
- Karen Heraty, Eli Lilly
- Miah Jung, CDER, FDA
- Suzanne Pattee, OCPP, FDA
- Danielle Villata, CDER, FDA
- Patrick Zhou, CDER, FDA
Webinar Resources:
Recording of Virtual Public Workshop Now Available: Enhancing Diversity in Clinical Studies
A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is now available.
Day 1 of the virtual public workshop opened with welcoming remarks from Karen A. Hicks, Deputy Director of the FDA’s Office of Medical Policy (OMP). Following the opening remarks, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), delivered the keynote address. Following the keynote, multiple speaker presentations and panel discussions were held, including topics such as an overview of clinical study diversity, establishment of clinical study enrollment goals, approaches to support the inclusion of underrepresented populations in clinical studies, and more. The first day concluded with closing remarks from Karen Hicks.
Day 2 of the workshop began with opening remarks from Mathilda Fienkeng, Director of the FDA’s Division of Medical Policy Development at the OMP. Following the opening remarks, further presentations and panel discussions were held on approaches to support the inclusion of individuals with mental illness in clinical trials, how to use digital health tools to increase clinical study diversity, community engagement, and next steps to enhance clinical study diversity with respect to the FDA’s overall mission. The second and final day of the workshop concluded with closing remarks from Hicks.
View the full slide deck to learn more about the methods to support the inclusion of various underrepresented populations in clinical studies.
This workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).