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  • Birds-of-a-Feather Round-table Discussion: Master Protocol Trial Designs & Data Management Considerations

  • About the Event...

    Birds-of-a-Feather Round Table Discussion:  Master Protocol Trial Designs & Data Management Considerations

    Date:  Thursday, Oct 29, 2020  Duration: One hour

    Facilitator:   Sara Hale, Amgen

    Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

    Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

    For This Topic:  

    Background --  Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.

    Discussion -- In this session, we will be looking to discuss:

    • set up, conduct and lock challenges and best practices Sponsor are identifying, including but not limited to:
      • utilization of multiple clinical trial databases(CTDB) and data management plans (DMP) to support sub-protocols
      • utilization of Interactive Response Technology (IRT) across multiple CTDBs/sub-protocols
      • people resourcing and oversight considerations across sub-protocols

    Time:  This Round-table discussion will start at UTC 1500 (California 8am, NYC 11am, London 1500, Brussels 1600, Helsinki 1700, Mumbai 2030, Beijing 11pm, Tokyo midnight.)  We sincerely apologize for the inconvenient time this is being offered in the APAC region. Because our facilitator is in California, we were limited with when we could offer this discussion.