A review of evidence supporting amyloid beta reduction as a surrogate endpoint in Alzheimer’s disease [PDF]
The Journal of Prevention of Alzheimer's DiseaseAlzheimer’s disease (AD) is a heterogeneous neurodegenerative disease driven by pathological depositions of proteins that accumulate over decades. Compelling genetic and neurobiological evidence suggests that amyloid accumulation in the brain initiates ...
Tianle Chen +13 more
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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
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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
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Incorporating Covariates into Measures of Surrogate Paradox Risk
Stats, 2023 Clinical trials often collect intermediate or surrogate endpoints other than their true endpoint of interest. It is important that the treatment effect on the surrogate endpoint accurately predicts the treatment effect on the true endpoint.
Fatema Shafie Khorassani +3 more
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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
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Evaluating amyloid-beta as a surrogate endpoint in trials of anti-amyloid-beta drugs in Alzheimer’s disease: a Bayesian meta-analysis [PDF]
Journal of Comparative Effectiveness ResearchAim: The use of amyloid-beta (Aβ) clearance to support regulatory approvals of drugs in Alzheimer’s disease (AD) remains controversial. We evaluate Aβ as a potential trial-level surrogate endpoint for clinical function in AD.
Sa Ren +10 more
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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
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BMJ Open, 2022 Introduction Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life).
Martin Offringa +10 more
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A perfect correlate does not a surrogate make
BMC Medical Research Methodology, 2003 Background There is common belief among some medical researchers that if a potential surrogate endpoint is highly correlated with a true endpoint, then a positive (or negative) difference in potential surrogate endpoints between randomization groups ...
Kramer Barnett S, Baker Stuart G
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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
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