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
doaj +2 more sources
Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011
Journal of the American Heart Association, 2017 Background Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes.
Joseph S. Ross +2 more
exaly +3 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
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
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
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
Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm [PDF]
Blood Cancer JournalMeasurement of overall survival (OS) remains the gold standard for interpreting the impact of new therapies for multiple myeloma in phase 3 trials. However, as outcomes have improved, it is increasingly challenging to use OS as the primary endpoint if ...
Charlotte Pawlyn +15 more
doaj +2 more sources
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
doaj +1 more source
Frontiers in Medicine, 2022 Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications.
Abena S. Agyeman +2 more
doaj +1 more source
Food and Drug Administration approvals in phase 3 Cancer clinical trials
BMC Cancer, 2021 Background Phase 3 oncologic randomized clinical trials (RCTs) can lead to Food and Drug Administration (FDA) approvals. In this study, we aim to identify trial-related factors associated with trials leading to subsequent FDA drug approvals.
Joseph Abi Jaoude +13 more
doaj +1 more source