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Biomarkers and surrogate endpoints [PDF]
British Journal of Clinical Pharmacology, 2005 When David Beckham leaves the field towards the end of a match, the man who replaces him is a surrogate. and although I suspect that many footballers, if asked, would say that Surrogate is a town in Yorkshire, the word actually comes from the Latin word subrogare, to substitute.
openaire +3 more sources
A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint
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 +2 more
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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
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PLoS ONE, 2014 AimThere 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.MethodsWe conducted an online questionnaire that targeted various ...
Bauke Schievink +4 more
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PLoS ONE, 2020 BACKGROUND AND OBJECTIVE:The use of valid surrogate endpoints can accelerate the development of phase III trials. Numerous validation methods have been proposed with the most popular used in a context of meta-analyses, based on a two-step analysis ...
Casimir Ledoux Sofeu, Virginie Rondeau
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Evaluation of the effectiveness of lipid-lowering agents
Учёные записки Санкт-Петербургского государственного медицинского университета им. Акад. И.П. Павлова, 2020 Introduction. Nowadays, lipid-lowering therapy is considered an essential strategy for primary and secondary prevention of cardiovascular outcomes, which is confirmed by numerous studies. Nevertheless, researches are often guided by analysis of surrogate
V. G. Shevko +3 more
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Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences [PDF]
Brazilian Oral Research, 2020 Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the
PEDRAZZI Vinicius +5 more
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Surrogate endpoint evaluation using data from one large global randomized controlled trial
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 +4 more
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PLoS Medicine, 2019 BackgroundIn situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing ...
Catherine Schuster Bruce +3 more
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BMC Medicine, 2018 Background The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product’s actual ...
Joshua D. Wallach +6 more
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