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Master Protocol Workshop


Session 5: Data and Information Sharing in Complex Innovative Trials

Session Chair(s)

Sudheer  Doss, PhD

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

Data and Information Sharing in Complex Innovative Trials

Sudheer Doss, PhD

  • Chief Data Officer and Head of Business Development
  • Pancreatic Cancer Action Network, United States
Shanna  Allen, MPH

Master Protocols – What About the Data?

Shanna Allen, MPH

  • Clinical Operations Regional Lead
  • Global Coalition for Adaptive Research, United States
Raj  Malathker

An Execution Platform for Implementing Innovative Trial and Project Designs

Raj Malathker

  • Senior Manager, Quantitative Sciences IT
  • Janssen Pharmaceutical , United States
Representative Invited

Speaker

Representative Invited

  • Janssen R&D, at Johnson & Johnson, United States
Michelle  Detry, PhD

Data and Information Sharing Considerations for Master Protocol Trials

Michelle Detry, PhD

  • Director, Adaptive Trial Execution & Senior Statistical Scientist
  • Berry Consultants LLC, United States