James Carpenter

Jul 16, 2024 | onlinelibrary.wiley.com | Suzie Cro |James Roger |James Carpenter

1 Introduction In pivotal clinical trials with longitudinal follow-up, it is now common practice to attempt to collect full outcome data after the withdrawal of randomised treatment up until the nominal end of study. This allows the study to readily adopt a treatment-policy strategy for handling treatment withdrawal, to target the effect of the randomised treatment regardless of any treatment non-adherence [1]. As discussed by Wang et al.

Apr 17, 2024 | onlinelibrary.wiley.com | Suzie Cro |Tim Morris |James Roger |James Carpenter

REFERENCES 1, , , , , . Standard and reference-based conditional mean imputation. Pharm Stat. 2022; 21(6): 1246-1257. doi:10.1002/pst.2234 2, , . Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions and inference via multiple imputation. J Biopharm Stat. 2013; 23(6): 1352-1371. 3. Multiple-imputation inferences with uncongenial sources of input. Stat Sci. 1994; 9(4): 538-558. 4, .

Apr 17, 2024 | onlinelibrary.wiley.com | Suzie Cro |Tim Morris |James Roger |James Carpenter

Accurate frequentist performance of a method is desirable in confirmatory clinical trials, but is not sufficient on its own to justify the use of a missing data method.