| Literature DB >> 31184495 |
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.Entities:
Keywords: Estimand; intention-to-treat; pain; sensitivity analysis; treatment strategy
Mesh：
Year: 2019 PMID： 31184495 DOI： 10.1177/1740774519853566
Source DB: PubMed Journal: Clin Trials ISSN： 1740-7745 Impact factor: 2.486