Category 9: Standards for Adaptive and Bayesian Trial Designs
Learning Objectives
Cognitive: Compare the different types of adaptive trial designs; Describe the inferential philosophy underlying Bayesian statistics and its advantages over non-Bayesian approaches to inference; Evaluate the statistical properties of adaptive trial designs; Outline a structure and analysis plan for a Bayesian or adaptive randomized clinical trial (RCT) design.
Attitudinal: Value considerations of clinical equipoise in relation to the implications of adapting randomization during an RCT.
Skills: Formulate appropriate prior distributions for Bayesian trial designs; Demonstrate that clinical trial infrastructure is adequate to support planned adaptations; Select factors that will lead to successful adaptive or Bayesian trial designs; Choose appropriate considerations for interim and final analyses of data from adaptive and Bayesian clinical trials; Report adaptive RCTs using the CONsolidated Standards Of Reporting Trials (CONSORT) statement.
Learning Modules
This category contains the curriculum Introduction and ten main modules. Learn about the instructors for this curriculum.
- Introductory Lecture: Prepared and presented by Jodi Segal, MD, MPH
- Learning Modules: Prepared and presented by Gary Rosner, ScD
Module 1: Introduction
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Module 2: Review of the Objectives (Skills)
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Module 3a: Overview
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Module 3b: Background
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Module 4: Planning an Adaptive Clinical Trial
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Module 5: Statistical Properties of Adaptive Clinical Trials
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Module 6: Specifying the Structure and Analysis Plan
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Module 7: Infrastructure for Adaptive Clinical Trials
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Module 8: Reporting Results of Adaptive Clinical Trials
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Module 9: Other Considerations and Recommendations for Adaptive and Bayesian Clinical Trials
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Module 10: Summary
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Interview with Nancy Kass, ScD, Phoebe R. Berman Professor of Bioethics and Public Health in the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Deputy Director for Public Health in the Berman Institute of Bioethics, on Ethical Issues Related to Adaptive Trials
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Category 9 Self-Assessment
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Back to the Methodology Standards Academic Curriculum main page
Posted: February 2016
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