A constructive critique of the draft ICH E9 Addendum.
Daniel O ScharfsteinPublished in: Clinical trials (London, England) (2019)
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.