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BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

Thursday, Oct 29, 2020

Event date: 29/10/2020 Export event

BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

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:  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.  This round-table discussion will start at UTC 1500.

eClinical Forum Members -- FOLLOW THIS LINK TO REGISTER: https://eclinicalforum.org/Forms/Master-Protocol

Non-Members -- please send an email to info@eclinicalforum.org to request information about becoming a member.

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