Results 31 to 40 of about 277,103 (274)
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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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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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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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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Surrogate Endpoints: Application in Pediatric Clinical Trials [PDF]
, 2013 This chapter examines the use of surrogate endpoints in clinical research in general and the role that they can play in pediatric research in particular.
Molenberghs, Geert, Geert Molenberghs
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JHEP ReportsBackground & Aims: The goal of treatment in autoimmune hepatitis (AIH) is induction of remission to prevent the development of liver fibrosis, cirrhosis, and its related complications. Various definitions of treatment response and remission have been
Lorenz Grossar +13 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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, 2022 Cutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer. Treatment of advanced CSCC has traditionally been performed with chemotherapies with predominately poor results. Recently Immunotherapy (IO) has shown promising effectiveness,
Kim, H, Nalder, M
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Comparing Biomarkers as Principal Surrogate Endpoints [PDF]
Biometrics, 2011 Recently a new definition of surrogate endpoint, the "principal surrogate," was proposed based on causal associations between treatment effects on the biomarker and on the clinical endpoint. Despite its appealing interpretation, limited research has been conducted to evaluate principal surrogates, and existing methods focus on risk models that consider
Huang, Ying, Gilbert, Peter B.
openaire +3 more sources