Methods for non-proportional hazards in clinical trials: A systematic review [PDF]
For the analysis of time-to-event data, frequently used methods such as the log-rank test or the Cox proportional hazards model are based on the proportional hazards assumption, which is often debatable. Although a wide range of parametric and non-parametric methods for non-proportional hazards has been proposed, there is no consensus on the best ...
Tim Friede +2 more
exaly +9 more sources
Survival analysis: coping with non proportional hazards in randomized trials [PDF]
Almost all trials with a censored time-to-event outcome are designed, powered and analysed with a target hazard ratio for comparing experimental and control treatments in mind. Differences in survival experience between trial arms are tested with a logrank test and usually illustrated using a Kaplan-Meier plot.
Royston Patrick, Parmar Mahesh KB
doaj +4 more sources
Comparison of statistical methods for the analysis of recurrent adverse events in the presence of non-proportional hazards and unobserved heterogeneity: a simulation study [PDF]
Background In preventive drug trials such as intermittent preventive treatment for malaria prevention during pregnancy (IPTp), where there is repeated treatment administration, recurrence of adverse events (AEs) is expected.
Noel Patson +6 more
doaj +2 more sources
Interval-Censored Regression with Non-Proportional Hazards with Applications
Proportional hazards models and, in some situations, accelerated failure time models, are not suitable for analyzing data when the failure ratio between two individuals is not constant. We present a Weibull accelerated failure time model with covariables
Fábio Prataviera +4 more
doaj +2 more sources
Augmenting the logrank test in the design of clinical trials in which non-proportional hazards of the treatment effect may be anticipated [PDF]
Background Most randomized controlled trials with a time-to-event outcome are designed assuming proportional hazards (PH) of the treatment effect. The sample size calculation is based on a logrank test.
Patrick Royston, Mahesh K.B. Parmar
doaj +2 more sources
Group sequential design for time-to-event outcome with non-proportional hazards using the concept of relative time utilizing two different Weibull distributions [PDF]
A group sequential design allows investigators to sequentially monitor efficacy and safety as part of interim testing in phase III trials. Literature is well developed in the case of continuous and binary outcomes, however, in case of trials with a time ...
Milind A. Phadnis +2 more
doaj +2 more sources
Comparison between asymptotic and re-randomisation tests under non-proportional hazards in a randomised controlled trial using the minimisation method [PDF]
Background Pocock-Simon’s minimisation method has been widely used to balance treatment assignments across prognostic factors in randomised controlled trials (RCTs).
Ryusei Kimura +3 more
doaj +2 more sources
A Bayesian spline-augmented piecewise exponential model with spatial frailty for under-five mortality in Nigeria [PDF]
IntroductionThe Cox proportional hazards (PH) model is widely used in time-to-event research, but its validity depends on the PH assumption, which can be violated in child mortality studies where hazards vary with age. Piecewise exponential models (PEMs)
Peter Enesi Omaku +2 more
doaj +2 more sources
Background: Cox proportional hazard regression (CPH) model relies on the proportional hazard (PH) assumption: the hazard of variables is independent of time. CPH has been widely used to identify prognostic markers of the transcriptome.
Zihang Zeng +7 more
doaj +1 more source
Numerous methods and approaches have been developed for generating time-to-event data from the Cox Proportional Hazards (CPH) model; however, they often require specification of a parametric distribution for the baseline hazard even though the CPH model ...
Jennifer L. Delzeit, Devin C. Koestler
doaj +1 more source

