Affiliation:
1. Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
Abstract
In this article, I review the key elements of the proposed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E9 Addendum, present a constructive critique, and provide recommendations of how it can be improved. To highlight ideas, I present a case study involving a confirmatory trial for a chronic pain medication.
Subject
Pharmacology,General Medicine
Reference23 articles.
1. International Conference on Harmonization.Guideline: statistical principles for clinical trials. Technical report no. ICH/363/96, 16 September 1998. Silver Spring: FDA.
2. Estimands and Their Role in Clinical Trials
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