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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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Endpoints: Surrogates and Composites
Cardiovascular Revascularization Medicine, 2022openaire +2 more sources
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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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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FDA validation of surrogate endpoints in oncology: 2005–2022
Journal of Cancer Policy, 2022Vinay Prasad +2 more
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