Results 11 to 20 of about 510,312 (368)

Evaluating Clinical Efficacy of Antiviral Therapy for COVID-19: A Surrogate Endpoint Approach. [PDF]

Infect Dis Ther, 2021
Efficient evaluation with an early surrogate endpoint, taking into account the process of disease evolution, may not only clarify inconsistent or underpowered results but also provide a new insight into the exploration of a new antiviral therapy for ...
Jen HH, Chang WJ, Lin TY, Hsu CY, Yen AM, Lai CC, Chen TH.   +6 more
europepmc   +4 more sources

The Relationship Between Short-Term Surrogate Endpoint Indicators and mPFS and mOS in Clinical Trials of Malignant Tumors: A Case Study of Approved Molecular Targeted Drugs for Non-Small-Cell Lung Cancer in China

Frontiers in Pharmacology, 2022
Objective: Due to the initiation of the priority review program in China, many antitumor drugs have been approved for marketing based on phase II clinical trials and short-term surrogate endpoint indicators.
Mingjun Rui, Mingjun Rui, Zijing Wang, Zijing Wang, Zhengyang Fei, Zhengyang Fei, Yao Wu, Yao Wu, Yingcheng Wang, Yingcheng Wang, Lei Sun, Ye Shang, Ye Shang, Hongchao Li, Hongchao Li   +14 more
doaj   +2 more sources

Examining amyloid reduction as a surrogate endpoint through latent class analysis using clinical trial data for dominantly inherited Alzheimer's disease. [PDF]

Alzheimers Dement
Increasing evidence suggests that amyloid reduction could serve as a plausible surrogate endpoint for clinical and cognitive efficacy. The double‐blind phase 3 DIAN‐TU‐001 trial tested clinical and cognitive declines with increasing doses of solanezumab ...
Wang G, Li Y, Xiong C, Benzinger TLS, Gordon BA, Hassenstab J, Aschenbrenner AJ, McDade E, Clifford DB, Libre-Guerra JJ, Shi X, Mummery CJ, van Dyck CH, Lah JJ, Honig LS, Day G, Ringman JM, Brooks WS, Fox NC, Suzuki K, Levin J, Jucker M, Delmar P, Bittner T, Bateman RJ, DIAN‐TU Study Team.   +25 more
europepmc   +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, Benjamin Ole Wolthers, Frederik Flindt Kreiner, Søren Rasmussen, Robert Bauer   +4 more
doaj   +2 more sources

Quetiapine-Related Deaths: In Search of a Surrogate Endpoint [PDF]

Toxics
Quetiapine 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

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

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 Research
Aim: 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, Janharpreet Singh, Sandro Gsteiger, Christopher Cogley, Ben Reed, Keith R Abrams, Dalia Dawoud, Rhiannon K Owen, Paul Tappenden, Terrence J Quinn, Sylwia Bujkiewicz   +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, Yang Wang, Wei Li, Xiaoyun Liu, Yanyan Zhao, Chuangshi Wang, Xiaocong Li, Yingxuan Zhu, Mengya Li, Lei Song, Bo Xu   +10 more
doaj   +2 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, Qunxiong Pan, Mingdong Lu, Bin Zhao   +3 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, Michele Germano, Angela Maggio, Raimondo Massaro, Domenico Rosario Potenza, Aldo Russo, Massimo Carella, Giuseppe Di Stolfo   +7 more
doaj   +2 more sources