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The Evaluation of Multiple Surrogate Endpoints
Biometrics, 2001Summary.Surrogate endpoints are desirable because they typically result in smaller, faster efficacy studies compared with the ones using the clinical endpoints. Research on surrogate endpoints has received substantial attention lately, but most investigations have focused on the validity of using a single biomarker as a surrogate.
Xu, Jane, Zeger, Scott L.
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Validating Surrogate Endpoints
2013The International Conference of Harmonisation (ICH) Guideline E9, Statistics Principles for Clinical Trials, recommends that surrogate endpoints in clinical trials be validated using either (1) the sensitivity-specificity approach or (2) regression analysis.
Ton J. Cleophas, Aeilko H. Zwinderman
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Surrogate Endpoints of Clinical Benefit
2012Despite several decades of intensive clinical and biological research and significant progress in primary prevention, screening, diagnosis, prognosis, and treatment, cancer is still the second most common cause of death in developed countries, accounting for about one-fourth of total deaths [1].
G. Ciccone, BALDI, ILEANA
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Bulletin du cancer, 1999
The main endpoint of a phase III trial in oncology must be relevant clinically. In practice, this endpoint is either the disease-free or the overall survival, which requires both long term follow-up and a large number of patients. In phase II trials, it is essential to proceed rapidly, and one therefore uses a surrogate endpoint.
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The main endpoint of a phase III trial in oncology must be relevant clinically. In practice, this endpoint is either the disease-free or the overall survival, which requires both long term follow-up and a large number of patients. In phase II trials, it is essential to proceed rapidly, and one therefore uses a surrogate endpoint.
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Clinical potential of microdystrophin as a surrogate endpoint
Neuromuscular Disorders, 2022J. Boehler +12 more
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Clinical trials: surrogate endpoints or hard endpoints?
The American Journal of Cardiology, 2001A man, aged 50, has about a 50% risk and a 50-year-old woman a 35% risk of having a myocardial infarction during their lifetime. The extent of atherosclerosis is the primary determinant of the risk of myocardial infarction. We will be unable to substantially reduce the lifetime risk of coronary artery disease without primary prevention of ...
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Endpoints: Surrogates and Composites
Cardiovascular Revascularization Medicine, 2022openaire +2 more sources
Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease.
Nutrition reviews, 2008This article reviews surrogate endpoints and emerging biomarkers that were discussed at the annual "Cardiovascular Biomarkers and Surrogate Endpoints" symposium cosponsored by the US Food and Drug Administration (FDA) and the Montreal Heart Institute.
Crystal M, Rasnake +2 more
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