The global patient-reported outcomes for multiple sclerosis initiative: bridging the gap between clinical research and care–updates at the 2023 plenary event
P Zaratin, S Samadzadeh, M Seferoğlu… - Frontiers in …, 2024 - frontiersin.org
Significant advancements have been achieved in delineating the progress of the Global
PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the …
PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the …
Interpretability of cancer clinical trial results using restricted mean survival time as an alternative to the hazard ratio
Importance In a comparative clinical study with progression-free survival (PFS) or overall
survival (OS) as the end point, the hazard ratio (HR) is routinely used to design the study …
survival (OS) as the end point, the hazard ratio (HR) is routinely used to design the study …
Understanding and communicating measures of treatment effect on survival: can we do better?
ED Saad, JR Zalcberg, J Péron, E Coart… - JNCI: Journal of the …, 2018 - academic.oup.com
Time-to-event end points are the most frequent primary end points in phase III oncology
trials, both in the adjuvant and advanced settings. The evaluation of these end points is …
trials, both in the adjuvant and advanced settings. The evaluation of these end points is …
Log-rank test vs MaxCombo and difference in restricted mean survival time tests for comparing survival under nonproportional hazards in immuno-oncology trials: a …
P Mukhopadhyay, J Ye, KM Anderson… - JAMA …, 2022 - jamanetwork.com
Importance The log-rank test is considered the criterion standard for comparing 2 survival
curves in pivotal registrational trials. However, with novel immunotherapies that often violate …
curves in pivotal registrational trials. However, with novel immunotherapies that often violate …
Robust design and analysis of clinical trials with nonproportional hazards: a straw man guidance from a cross-pharma working group
Loss of power and clear description of treatment differences are key issues in designing and
analyzing a clinical trial where nonproportional hazard (NPH) is a possibility. A log-rank test …
analyzing a clinical trial where nonproportional hazard (NPH) is a possibility. A log-rank test …
The win ratio: on interpretation and handling of ties
G Dong, DC Hoaglin, J Qiu, RA Matsouaka… - Statistics in …, 2020 - Taylor & Francis
To handle composite endpoints, the win ratio has been applied to data analysis and design
of clinical trials. Its interpretation, however, is not always clear, and it could handle ties …
of clinical trials. Its interpretation, however, is not always clear, and it could handle ties …
The inverse-probability-of-censoring weighting (IPCW) adjusted win ratio statistic: an unbiased estimator in the presence of independent censoring
The win ratio method has received much attention in methodological research, ad hoc
analyses, and designs of prospective studies. As the primary analysis, it supported the …
analyses, and designs of prospective studies. As the primary analysis, it supported the …
Composite metric for benchmarking site performance in transcatheter aortic valve replacement: results from the STS/ACC TVT Registry
ND Desai, SM O'Brien, DJ Cohen, J Carroll… - Circulation, 2021 - Am Heart Assoc
Background: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for
aortic stenosis. Despite rapid improvements in technology and techniques, serious …
aortic stenosis. Despite rapid improvements in technology and techniques, serious …
An extension of generalized pairwise comparisons for prioritized outcomes in the presence of censoring
Generalized pairwise comparisons have been proposed to permit a comprehensive
assessment of several prioritized outcomes between two groups of observations. This …
assessment of several prioritized outcomes between two groups of observations. This …