Results 31 to 40 of about 510,312 (368)

Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications

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, Jeffrey N. Siegel, Christopher Leptak   +2 more
doaj   +1 more source

Evaluation of pathological complete response as surrogate endpoint in neoadjuvant randomised clinical trials of early stage breast cancer: systematic review and meta-analysis

British medical journal, 2021
Objective To evaluate pathological complete response as a surrogate endpoint for disease-free survival and overall survival in regulatory neoadjuvant trials of early stage breast cancer. Design Systematic review and meta-analysis.
F. Conforti, L. Pala, I. Sala, Chiara Oriecuia, T. D. De Pas, C. Specchia, R. Graffeo, E. Pagan, P. Queirolo, E. Pennacchioli, M. Colleoni, G. Viale, V. Bagnardi, R. Gelber   +13 more
semanticscholar   +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, Ramez Kouzy, Marc Ghabach, Roshal Patel, Dario Pasalic, Elie Ghossain, Austin B. Miller, Timothy A. Lin, Vivek Verma, C. David Fuller, Vivek Subbiah, Bruce D. Minsky, Ethan B. Ludmir, Cullen M. Taniguchi   +13 more
doaj   +1 more source

Exploration of modified progression-free survival as a novel surrogate endpoint for overall survival in immuno-oncology trials

Journal for ImmunoTherapy of Cancer, 2021
Background Progression-free survival (PFS) exhibits suboptimal performance as the surrogate endpoint for overall survival (OS) in trials studying immune checkpoint inhibitors (ICIs).
Zixian Wang, Hao-xiang Wu, Li Xie, Wu-Hao Lin, F. Liang, Jin Li, Zhimin Yang, R. Xu   +7 more
semanticscholar   +1 more source

Correction to: 1-¹³C-propionate breath testing as a surrogate endpoint to assess efficacy of liver-directed therapies in methylmalonic acidemia (MMA). [PDF]

Genet Med, 2021
Manoli I, Pass AR, Harrington EA, Sloan JL, Gagné J, McCoy S, Bell SL, Hattenbach JD, Leitner BP, Duckworth CJ, Fletcher LA, Cassimatis TM, Galarreta CI, Thurm A, Snow J, Van Ryzin C, Ferry S, Mew NA, Shchelochkov OA, Chen KY, Venditti CP.   +20 more
europepmc   +3 more sources

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
doaj   +1 more source

Progression-Free Survival as Early Efficacy Endpoint in Resectable Esophageal Cancer Treated With Neoadjuvant Therapy: A Systematic Review

Frontiers in Oncology, 2022
To investigate literature-based evidence regarding progression-free survival (PFS) as an early efficacy endpoint in patients with resectable esophageal or gastroesophageal junction (GEJ) cancer receiving neoadjuvant therapy, this study identified large ...
Jie Zhu, Jie Zhu, Jin Tao, Zhen Dai, Yan Tan, Yan Tan, Li Jiang, Li Jiang, Qifeng Wang, Qifeng Wang, Jinyi Lang, Jinyi Lang   +11 more
doaj   +1 more source

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 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.
Behnood Bikdeli, Natdanai Punnanithinont, Yasir Akram, Ike Lee, Nihar R. Desai, Joseph S. Ross, Harlan M. Krumholz   +6 more
doaj   +1 more source

Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancer

Cancer Reports, 2021
Background The purpose of this study was to investigate the correlation between overall survival (OS) and other clinical outcomes in patients with prostate cancer. Further, we conducted subgroup analysis in the correlation of OS.
Hideki Maeda, Kentaro Takeda, Hisashi Urushihara, Tatsuo Kurokawa   +3 more
doaj   +1 more source

Effect of estimating equations for glomerular filtration rate on novel surrogate markers for renal outcome [PDF]

Kidney Research and Clinical Practice, 2021
Backgrounds Recently, alternative surrogate endpoints such as a 30% or 40% decline in estimated glomerular filtration rate (eGFR) or eGFR slope over 2 to 3 years have been proposed for predicting renal outcomes.
Kipyo Kim, Eunji Baek, Suryeong Go, Hyung-Eun Son, Ji-Young Ryu, Yongjin Yi, Jong Cheol Jeong, Sejoong Kim, Ho Jun Chin   +8 more
doaj   +1 more source