@article{0d15bee3604b436ea1291060028e878d,
title = "A constructive critique of the draft ICH E9 Addendum",
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.",
keywords = "Estimand, intention-to-treat, pain, sensitivity analysis, treatment strategy",
author = "Scharfstein, {Daniel O.}",
note = "Funding Information: My views have been formed through discussions with Miguel Hernan, Johns Hopkins Causal Inference Group (including, among others, Michael Rosenblum, Elizabeth Ogburn, and Elizabeth Stuart), Nicholas King, Jonathan Darrow, Jeremy Sugarman, Raja Srinivasa, Thomas Permutt, Frank Bretz, and Rob Hemmings. I have received funding from National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute (PCORI), and US Food and Drug Administration (FDA) for the development of statistical methods and associated software. Funding Information: I have received funding from National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute (PCORI), and US Food and Drug Administration (FDA) for the development of statistical methods and associated software. Publisher Copyright: {\textcopyright} The Author(s) 2019.",
year = "2019",
month = aug,
day = "1",
doi = "10.1177/1740774519853566",
language = "English (US)",
volume = "16",
pages = "375--380",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "4",
}