Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Clin Trials. 2019 Aug;16(4):345-349. doi: 10.1177/1740774519830358. Epub 2019 Feb 14.
The proposed addendum to the International Conference on Harmonization document, , can be read in two ways. There is a new framework for talking about estimands, but is it about fitting present methods into the framework? Or is it about changing methods? My answer: some of each. Where different methods are needed, there are challenging problems in estimating some desirable estimands, but there may also be desirable estimands that can be estimated easily and robustly.
可以从两个角度解读拟议的《国际协调会议文献增编》。一方面，它为评估目标提供了新的框架，那么这是将现有方法纳入框架的问题，还是改变方法的问题？我的答案是：两者都有。在需要不同方法的地方，估计某些理想的评估目标存在具有挑战性的问题，但也可能存在可以容易且稳健地估计的理想评估目标。
