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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

Pritibha Singh, MBA, MSc

  • Global Program Associate Director, Oncology Hematology Development
  • Novartis AG, Switzerland
Maria  Apostolaros, JD, PharmD, MS, RPh

Maria Apostolaros, JD, PharmD, MS, RPh

  • PhRMA, United States
Representative Invited

Representative Invited

  • FDA, United States
Karen Lynn Price, PhD

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)

Pritibha  Singh, MBA, MSc

Speaker

Pritibha Singh, MBA, MSc

  • Global Program Associate Director, Oncology Hematology Development
  • Novartis AG, Switzerland
Manisha  Desai, PhD

Apple Heart Study

Manisha Desai, PhD

  • Professor of Medicine and of Biomedical Data Science
  • Stanford University School of Medicine, United States
Ying  Yuan, PhD

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
Jackson Kempber Burton, PhD

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
Laura Lee  Johnson, PhD

Speaker

Laura Lee Johnson, PhD

  • Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
  • FDA, United States

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