Assessment of proportional hazard assumption in aggregate data: a systematic review on statistical methodology in clinical trials using time-to-event endpoint

E Rulli, F Ghilotti, E Biagioli, L Porcu… - British journal of …, 2018 - nature.com
Background The evaluation of the proportional hazards (PH) assumption in survival analysis
is an important issue when Hazard Ratio (HR) is chosen as summary measure. The aim is to …

Augmenting the logrank test in the design of clinical trials in which non-proportional hazards of the treatment effect may be anticipated

P Royston, MKB Parmar - BMC Medical Research Methodology, 2016 - Springer
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 …

[HTML][HTML] Methods for accommodating nonproportional hazards in clinical trials: ready for the primary analysis?

B Freidlin, EL Korn - Journal of Clinical Oncology, 2019 - ncbi.nlm.nih.gov
Evaluation of new anticancer therapies in randomized clinical trials (RCTs) is typically based
on comparing a new treatment with a standard one, using a time-toevent end point such as …

Are non-constant rates and non-proportional treatment effects accounted for in the design and analysis of randomised controlled trials? A review of current practice

K Jachno, S Heritier, R Wolfe - BMC medical research methodology, 2019 - Springer
Background Most clinical trials with time-to-event primary outcomes are designed assuming
constant event rates and proportional hazards over time. Non-constant event rates and non …

Comparison of treatment effects measured by the hazard ratio and by the ratio of restricted mean survival times in oncology randomized controlled trials

L Trinquart, J Jacot, SC Conner… - Journal of Clinical …, 2016 - ascopubs.org
Purpose We aimed to compare empirically the treatment effects measured by the hazard
ratio (HR) and by the difference (and ratio) of restricted mean survival times (RMST) in …

The Average Hazard Ratio–A Good Effect Measure for Time-to-event Endpoints when the Proportional Hazard Assumption is Violated?

G Rauch, W Brannath, M Brückner… - Methods of information …, 2018 - thieme-connect.com
Background: In many clinical trial applications, the endpoint of interest corresponds to a time-
to-event endpoint. In this case, group differences are usually expressed by the hazard ratio …

Properties of the weighted log‐rank test in the design of confirmatory studies with delayed effects

JL Jiménez, V Stalbovskaya… - Pharmaceutical statistics, 2019 - Wiley Online Library
Proportional hazards are a common assumption when designing confirmatory clinical trials
in oncology. This assumption not only affects the analysis part but also the sample size …

Meta-analysis when only the median survival times are known: a comparison with individual patient data results

S Michiels, P Piedbois, S Burdett, N Syz… - International journal of …, 2005 - cambridge.org
Background: The hazard ratio (HR) is the most appropriate measure for time to event
outcomes such as survival. In systematic reviews, HRs can be calculated either from the raw …

The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt

P Royston, MKB Parmar - Statistics in medicine, 2011 - Wiley Online Library
In most randomized clinical trials (RCTs) with a right‐censored time‐to‐event outcome, the
hazard ratio is taken as an appropriate measure of the effectiveness of a new treatment …

[HTML][HTML] Statistical considerations and endpoints for clinical lung cancer studies: Can progression free survival (PFS) substitute overall survival (OS) as a valid …

LR Pilz, C Manegold… - Translational lung cancer …, 2012 - ncbi.nlm.nih.gov
In the last decades significant progress has been achieved in the biological understanding
of non-small-cell lung cancer (NSCLC) and its tumor heterogeneity has become more …