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Activity Number:
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114
- Applying the ICH E9(R1) Addendum: Practical Considerations in Choosing Estimands, Estimators, and Sensitivity Analyzes
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 29, 2019 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304708
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Presentation
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Title:
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Lessons Learned from Implementing ICH E9 in Phase 2 Trials Across Multiple Therapeutic Areas
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Author(s):
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Jared Christensen*
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Companies:
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Pfizer Research
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Keywords:
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estimands;
phase 2;
ICH E9
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Abstract:
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The new ICH E9 directive has led clinical trialists to implement estimands in numerous trials. Drawing on lessons learned from early phase clinical trials, opportunities and challenges with the estimand framework will be discussed. The primary focus will be on the addition of estimands to clinical development plans and clinical trials including learnings from interactions within cross-functional teams implementing this guidance. Other lessons learned from the challenges of using new documentation and nomenclature to describe familiar concepts will also be discussed. Examples and lessons learned will be drawn from teams across multiple therapeutic areas.
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Authors who are presenting talks have a * after their name.
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