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DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Session 5: Alternative Data Sources and Historical Controls
Session Chair(s)
Pritibha Singh, MBA, MSc
- Global Program Associate Director, Oncology Hematology Development
- Novartis AG, Switzerland
Maria Apostolaros, JD, PharmD, MS, RPh
- PhRMA, United States
Representative Invited
- FDA, United States
Karen Lynn Price, PhD
- Senior Research Fellow, Statistical Innovation Center/Design Hub
- Eli Lilly and Company, United States
The CID program enables the exploration of the innovative use of alternative data sources. This exploration continues to be increasingly important as we encounter the emerging challenges with alternative data sources in methodological approaches to data collection, analysis, and benefit to the patients, regulators, and biopharmaceutical companies. This session will inspire and open you to the possibilities of utilizing alternative data sources, e.g. digital approaches to identify, screen, enroll, collect data on, and provide an intervention to patients.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand how to use digital applications to identify, screen, enroll, collect data on, and provide an intervention to patients
Speaker(s)
Speaker
Pritibha Singh, MBA, MSc
- Global Program Associate Director, Oncology Hematology Development
- Novartis AG, Switzerland
Apple Heart Study
Manisha Desai, PhD
- Professor of Medicine and of Biomedical Data Science
- Stanford University School of Medicine, United States
Borrowing Information from Historical Data: A Double-edged Sword
Ying Yuan, PhD
- Bettyann Asche Murray Distinguished Professor
- University of Texas MD Anderson Cancer Center, United States
DIA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients
Jackson Kempber Burton, PhD
- Scientific Director, Quantitative Medicine
- Critical Path Institute, United States
Speaker
Laura Lee Johnson, PhD
- Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
- FDA, United States
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Additional Information
Complex Innovative Clinical Trial Designs Resource Kit
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On Demand Content Preview Webinar
Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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