Results 1 to 10 of about 79,600 (335)

The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders. [PDF]

PLoS ONE, 2014
There is discussion whether medicines can be authorized on the market based on evidence from surrogate endpoints. We assessed opinions of different stakeholders on this topic.We conducted an online questionnaire that targeted various stakeholder groups ...
Bauke Schievink, Hiddo Lambers Heerspink, Hubert Leufkens, Dick De Zeeuw, Jarno Hoekman   +4 more
doaj   +11 more sources

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint [PDF]

Pilot and Feasibility Studies, 2018
Background It has been argued that true endpoints (or ‘hard’ endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival and cost.
M. J. Campbell, G. A. Lancaster, S. M. Eldridge   +2 more
doaj   +5 more sources

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 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 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

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

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

Use of surrogate endpoints in health technology assessment and reimbursement of treatments for the management of chronic kidney disease [PDF]

EClinicalMedicine
Summary: The judicious use of surrogate endpoints as substitutes for patient relevant target outcomes can substantially reduce the size and duration of clinical trials, thereby driving down research and development costs and driving faster patient access
Rod S. Taylor, Hiddo J.L. Heerspink, Marc Buyse, Oriana Ciani, Bruno Detournay, Daniel Gallego, Juan Carlos Julián Mauro, Smeeta Sinha, Marta Trapero-Bertran, Lesley A. Inker   +9 more
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