Results 1 to 10 of about 48,875 (105)

A framework for the definition and interpretation of the use of surrogate endpoints in interventional trialsResearch in context [PDF]

EClinicalMedicine, 2023
Summary: Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and ...
Oriana Ciani, Anthony M. Manyara, Philippa Davies, Derek Stewart, Christopher J. Weir, Amber E. Young, Jane Blazeby, Nancy J. Butcher, Sylwia Bujkiewicz, An-Wen Chan, Dalia Dawoud, Martin Offringa, Mario Ouwens, Asbjørn Hróbjartssson, Alain Amstutz, Luca Bertolaccini, Vito Domenico Bruno, Declan Devane, Christina D.C.M. Faria, Peter B. Gilbert, Ray Harris, Marissa Lassere, Lucio Marinelli, Sarah Markham, John H. Powers, Yousef Rezaei, Laura Richert, Falk Schwendicke, Larisa G. Tereshchenko, Achilles Thoma, Alparslan Turan, Andrew Worrall, Robin Christensen, Gary S. Collins, Joseph S. Ross, Rod S. Taylor   +35 more
doaj   +2 more sources

Surrogate endpoints in trials: a call for better reporting [PDF]

Trials, 2022
Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the
Oriana Ciani, Anthony M. Manyara, An-Wen Chan, Rod S. Taylor, on behalf of the SPIRIT-SURROGATE/CONSORT-SURROGATE project group   +4 more
doaj   +2 more sources

Surrogate Endpoints in Regulatory Decision‐Making [PDF]

Clinical and Translational Science
To support approval, FDA requires substantial evidence of effectiveness that demonstrates a drug improves meaningful clinical outcomes as measured by how a patient feels, functions, or survives.
Linda J. B. Jeng, Jeffrey Siegel
doaj   +2 more sources

Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States [PDF]

Clinical and Translational Science
Regulatory guidance documents exist on surrogate endpoints in the United States. In Japan, there are no established rules or guidance regarding the use of surrogate endpoints, and various aspects remain unclear.
Yuko Yamamoto, Harumi Kosaka, Hanami Nojiri, Hideki Maeda   +3 more
doaj   +2 more sources

Surrogate Endpoints in CLL: From Promise and Pitfalls to a Context-Specific Validation Framework [PDF]

Hematology Reports
Surrogate endpoints are increasingly used in chronic lymphocytic leukemia (CLL) to accelerate treatment evaluation, but their validity is context-dependent. This review examines key endpoints—progression-free survival (PFS), time to next treatment (TTNT),
Stefano Molica
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, Behnood Bikdeli, Harlan M. Krumholz   +2 more
exaly   +3 more sources

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

EClinicalMedicine, 2020
Background: In July 2018, the FDA first published a table listing all surrogate measures that it has used, and may accept for future use, in regulatory approval. However, the strength of surrogacy for those measures was not formally assessed.
Bishal Gyawali
exaly   +3 more sources

An alternative method to validate surrogate endpoints in oncology [PDF]

BMC Medical Research Methodology
Background Surrogate endpoints are often utilized to support drug efficacy claims. Hence, it is of paramount importance to validate the effectiveness of surrogate endpoints in correctly predicting clinical benefit, in order to ensure a fast and safe ...
Xingyue Zhu, Ting Yu, Die Xiao
doaj   +2 more sources

Surrogate endpoints in diabetic kidney disease: current perspectives and future directions [PDF]

Frontiers in Endocrinology
Diabetic kidney disease (DKD) represents a leading complication of diabetes, frequently progressing to end-stage renal disease (ESRD), which significantly impairs patients’ quality of life and imposes substantial healthcare burdens.
Can Cao, Jiale Zhang, Tong Ma, Juan Miao, Weiwei Sun   +4 more
doaj   +2 more sources

Blood biomarkers as surrogate endpoints in Alzheimer’s disease research [PDF]

Frontiers in Aging Neuroscience
BackgroundBlood biomarkers for Alzheimer’s disease (AD) can be utilized as surrogate endpoints to accelerate therapeutic development for this condition.MethodsWe assessed the association between short-term changes in blood biomarkers and long-term ...
Guogen Shan, Hui Li, Yahui Zhang, Guoqiao Wang, Charles Bernick   +4 more
doaj   +2 more sources