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Activity Number:
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497
- Implementation of the Estimand Framework: Next Steps for Steady and Consistent Progress?
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Type:
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Invited
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Date/Time:
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Thursday, August 11, 2022 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #320515
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Title:
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Lessons from Implementation of the Estimand Framework Across Projects
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Author(s):
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Elena Polverejan, PhD*
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Companies:
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Janssen Research & Development, LLC
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Keywords:
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estimand;
intercurrent event;
question of interest
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Abstract:
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While the ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” (2019) recommended a framework for clinical trial planning in which clear trial objectives are to “be translated into key scientific questions of interest by defining suitable estimands “, practical details of implementation were left up to each statistical department and connecting groups. They included: best practices for estimand definition and consistency across projects how to define the clinical questions of interest linked to an estimand steps from estimand definition to estimator specifications documentation of the estimands and estimators in protocols, Statistical Analysis Plans and output specifications communication with clinical, programming, regulatory and other groups strategies for COVID-19 related intercurrent events development of case studies and their dissemination This presentation will present some of the main lessons from a project-wise implementation of the estimand framework.
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Authors who are presenting talks have a * after their name.
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