Results 11 to 20 of about 82,696 (289)

Imputation of a true endpoint from a surrogate: application to a cluster randomized controlled trial with partial information on the true endpoint [PDF]

BMC Medical Research Methodology, 2003
Background The Anglia Menorrhagia Education Study (AMES) is a randomized controlled trial testing the effectiveness of an education package applied to general practices.
Duffy Stephen W, Nixon Richard M, Fender Guy RK   +2 more
doaj   +4 more sources

Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm [PDF]

Blood Cancer Journal
Measurement 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, Fredrik H. Schjesvold, David A. Cairns, L. J. Wei, Faith Davies, Omar Nadeem, Haifaa Abdulhaq, Maria-Victoria Mateos, Jacob Laubach, Katja Weisel, Heinz Ludwig, S. Vincent Rajkumar, Pieter Sonneveld, Graham Jackson, Gareth Morgan, Paul G. Richardson   +15 more
doaj   +2 more sources

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

J Immunother Cancer, 2021
Wang ZX, Wu HX, Xie L, Lin WH, Liang F, Li J, Yang ZM, Xu RH.   +7 more
europepmc   +3 more sources

Identification on surrogating overall survival with progression-free survival of first-line immunochemotherapy in advanced esophageal squamous cell carcinoma-an exploration of surrogate endpoint. [PDF]

BMC Cancer, 2023
Zhang Z, Xie C, Gao T, Yang Y, Yang Y, Zhao L.   +5 more
europepmc   +3 more sources

Early Estimated Glomerular Filtration Rate Trajectories After Kidney Transplant Biopsy as a Surrogate Endpoint for Graft Survival in Late Antibody-Mediated Rejection. [PDF]

Front Med (Lausanne), 2022
Borski A, Kainz A, Kozakowski N, Regele H, Kläger J, Strassl R, Fischer G, Faé I, Wenda S, Kikić Ž, Bond G, Reindl-Schwaighofer R, Mayer KA, Eder M, Wahrmann M, Haindl S, Doberer K, Böhmig GA, Eskandary F.   +18 more
europepmc   +3 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, Jeremy M. G. Taylor, Niko Kaciroti, Michael R. Elliott   +3 more
doaj   +1 more source

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

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

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   +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