A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint [PDF]
Pilot and Feasibility Studies, 2018 Background It has been argued that true endpoints (or ‘hard’ endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival and cost.
M. J. Campbell +2 more
doaj +5 more sources
An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse. [PDF]
PLoS ONE, 2013 It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis. The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment. Such trials are
Patrick P J Phillips +2 more
doaj +5 more sources
Principal causal effect identification and surrogate endpoint evaluation by multiple trials [PDF]
, 2015 Principal stratification is a causal framework to analyze randomized experiments with a post-treatment variable between the treatment and endpoint variables.
Ding, Peng, Geng, Zhi, Jiang, Zhichao
core +3 more sources
Intermediate endpoints as surrogates for outcomes in cancer immunotherapy: a systematic review and meta-analysis of phase 3 trialsResearch in context [PDF]
EClinicalMedicine, 2023 Summary: Background: Cancer immunotherapy shows unique efficacy kinetics that differs from conventional treatment. These characteristics may lead to the prolongation of trial duration, hence reliable surrogate endpoints are urgently needed.
Zhishan Zhang +3 more
doaj +2 more sources
Cardiovascular MRI in clinical trials: expanded applications through novel surrogate endpoints [PDF]
, 2011 Recent advances in cardiovascular magnetic resonance (CMR) now allow the accurate and reproducible measurement of many aspects of cardiac and vascular structure and function, with prognostic data emerging for several key imaging biomarkers.
Ashby, D +3 more
core +4 more sources
Quetiapine-Related Deaths: In Search of a Surrogate Endpoint [PDF]
ToxicsQuetiapine is a second-generation antipsychotic drug available for two and half decades. Due to increased misuse, prescription outside the approved indications, and availability on the black market, it is being encountered in medicolegal autopsies more ...
Ivan Šoša
doaj +2 more sources
Surrogate endpoint evaluation using data from one large global randomized controlled trial [PDF]
BMC Medical Informatics and Decision Making, 2021 Background Robust identification of surrogate endpoints can help accelerate the development of pharmacotherapies for diseases traditionally evaluated using true endpoints associated with prolonged follow-up.
Milan Geybels +4 more
doaj +2 more sources
Appropriate Surrogate Endpoint in Drug-Coated Balloon Trials for Coronary Artery Diseases [PDF]
Frontiers in Cardiovascular Medicine, 2022 BackgroundThe appropriateness of using late lumen loss (LLL) as a surrogate endpoint was established in drug-eluting stent (DES) studies, but it was less supportive for drug-coated balloon (DCB) trials.MethodsStudies published until 23 June 2021 were ...
Xinyue Lang +10 more
doaj +2 more sources
Electrocardiogram in Friedreich's ataxia: A short‐term surrogate endpoint for treatment efficacy [PDF]
Annals of Noninvasive Electrocardiology, 2021 Friedreich's ataxia is a rare degenerative neuromuscular disorder, caused by a homozygous GAA triplet repeat expansion in the frataxin (FXN) gene, with a broad clinical phenotype characterized by progressive gait and limb ataxia, dysarthria, and loss of ...
Sandra Mastroianno +7 more
doaj +2 more sources
Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis [PDF]
Scientific ReportsConfirming the patient benefit of progression-free survival (PFS) in B-cell non-Hodgkin lymphoma (B-NHL) and multiple myeloma (MM) has become increasingly challenging due to the improved outcomes brought by novel therapies. In parallel, the U.S. Food and
Satoshi Hirano +2 more
doaj +2 more sources