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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)
Data and Information Sharing in Complex Innovative Trials
Sudheer Doss, PhD
Pancreatic Cancer Action Network, United States
Chief Data Officer and Head of Business Development
Master Protocols – What About the Data?
Shanna Allen, MPH
Global Coalition for Adaptive Research, United States
Clinical Operations Regional Lead
An Execution Platform for Implementing Innovative Trial and Project Designs
Raj Malathker
Janssen Pharmaceutical , United States
Senior Manager, Quantitative Sciences IT
Speaker
Representative Invited
Janssen R&D, at Johnson & Johnson, United States
Data and Information Sharing Considerations for Master Protocol Trials
Michelle Detry, PhD
Berry Consultants LLC, United States
Director, Adaptive Trial Execution & Senior Statistical Scientist
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