title: Evaluating and adjusting for premature censoring of progression-free survival.
abstract: The intent-to-treat principle, grouping subjects as they were randomized and following all subjects to the endpoint or the end of study, allows valid statistical comparisons. Progression-free survival (PFS) has been used as a decision-making endpoint in oncology. It can be difficult to have a meaningful intent-to-treat analysis of PFS as some studies have extensive loss to follow-up for PFS. In the analysis, subjects lost to follow-up for PFS have their PFS times censored, with the censoring treated as noninformative. We use remaining overall survival to investigate whether premature censoring for PFS is informative and the potential bias in treating such censoring as noninformative.
authors: Division of Biometrics 5, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. Mark.Rothmann@fda.hhs.gov
authors: Mark
authors: M
authors: Rothmann
authors: Kallappa
authors: K
authors: Koti
authors: Kyung Yul
authors: KY
authors: Lee
authors: Hong Laura
authors: HL
authors: Lu
authors: Yuan Li
authors: YL
authors: Shen
authors: Jenny J
authors: JJ
authors: Zhang
authors: Mei
authors: M
authors: Jin
authors: Haojin
authors: H
authors: Zhou
mesh_terms: D003657:Decision Making; D018572:Disease-Free Survival; D023381:Endpoint Determination / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D059012:Lost to Follow-Up; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D016019:Survival Analysis