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Session 5: Data and Information Sharing in Complex Innovative Trials
Session Chair(s)
Sudheer Doss, PHD
Chief Data Officer and Head of Business Development, Pancreatic Cancer Action Network, United States
The Data and Information Sharing in Complex Innovative Trials session focuses on the balance across seamless trial execution, preservation of trial integrity, and maximization of research value from the data generated in complex innovative trials. Participants will hear about the challenges, risks, and solutions associated with two key aspects of data / information sharing:
- 1. Data and information availability / requirements for study execution
- 2. Sharing of data / information outside of study participants for secondary research
Learning Objective : At the conclusion of this session, participants should be able to:
- Outline the issues and opportunities associated with data and information sharing with complex innovative trials
- Identify the risks and challenges associated with data and information leakage during complex innovative trials
- Identify operational solutions being implemented to mitigate data / information sharing risk and maximize research value of complex innovative trials
Speaker(s)
Sudheer Doss, PHD
Chief Data Officer and Head of Business Development, Pancreatic Cancer Action Network, United States
Data and Information Sharing in Complex Innovative Trials
Shanna Allen, MPH
Clinical Operations Regional Lead, Global Coalition for Adaptive Research, United States
Master Protocols – What About the Data?
Raj Malathker
Senior Manager, Quantitative Sciences IT, Janssen Pharmaceutical , United States
An Execution Platform for Implementing Innovative Trial and Project Designs
Representative Invited
Vice President, Scientific Fellow, Janssen R&D, at Johnson & Johnson, United States
Speaker
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants, LLC, United States
Data and Information Sharing Considerations for Master Protocol Trials
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