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Surrogate and modified endpoints for immunotherapy in advanced hepatocellular carcinoma
Hepatology, 2023Background and Aims: Immunotherapies have altered the treatment paradigm in HCC. Surrogate and modified endpoints are used to assess early success in clinical studies and guide clinical practice.
Mir Lim +6 more
semanticscholar +1 more source
Using Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect
Statistics in Biopharmaceutical Research, 2021Delayed treatment effects have been commonly observed in clinical trials, which bring more challenges to the interim decision making particularly in adaptive designs setting.
Qing Li +4 more
semanticscholar +1 more source
Clinical Efficacy, Drug Safety, and Surrogate Endpoints
Neurology, 2021We recently learned that aducanumab has been approved by the US Food and Drug Administration (FDA) for the treatment of Alzheimer disease. As neurologists, we need to carefully review the evidence from the phase 1B and III randomized controlled clinical ...
L. Hershey, R. Tarawneh
semanticscholar +1 more source
2023
In Chapter 3, I utilize publicly available datasets of gene expression and DNA methylation in sarcomas to interrogate PRC2-dependent mechanisms of epigenetic crosstalk. I have shown that loss of PRC2 correlates with a global hypermethylation profile, tumor microenvironment changes, and patient outcome.
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In Chapter 3, I utilize publicly available datasets of gene expression and DNA methylation in sarcomas to interrogate PRC2-dependent mechanisms of epigenetic crosstalk. I have shown that loss of PRC2 correlates with a global hypermethylation profile, tumor microenvironment changes, and patient outcome.
openaire +1 more source
Evaluating surrogate endpoints
Controlled Clinical Trials, 2002The validation of surrogate endpoints has been studied by Prentice, who presented a definition as well as a set of criteria that are equivalent if the surrogate and true endpoints are binary. Freedman et al. supplemented these criteria with the so-called proportion explained.
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What Clinicians Should Know About Surrogate Endpoints in Hematologic Malignancies.
BloodUse of surrogates as primary endpoints is commonplace in hematology/oncology clinical trials. As opposed to prognostic markers, surrogates are endpoints that can be measured early and yet can still capture the full effect of treatment, as it would be ...
Côme Bommier, M. Maurer, J. Lambert
semanticscholar +1 more source
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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Change in albuminuria as a surrogate endpoint
Current Opinion in Nephrology and Hypertension, 2019Chronic kidney disease is a global health problem with few effective therapies available that slow the progression to end-stage renal disease. The established clinical endpoints for renal trials; doubling of serum creatinine or end-stage renal disease, are late manifestations of CKD.
Simke W, Waijer +2 more
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Surrogate Endpoints in Localized Prostate Cancer
Cancer Journal, 2020Randomized clinical trials assessing novel therapies in men with localized prostate cancer frequently require large patient numbers and more than a decade of follow-up to demonstrate improvements in overall survival. As the landscape of treatment options
H. Hartman, W. Jackson
semanticscholar +1 more source
Surrogate Endpoints in Suicide Research
Suicide and Life-Threatening Behavior, 2010Surrogate endpoints frequently substitute for rare outcomes in research. The ability to learn about completed suicides by investigating more readily available and proximate outcomes, such as suicide attempts, has obvious appeal. However, concerns with surrogates from the statistical science perspective exist, and mounting evidence from psychometric ...
Hal S, Wortzel +4 more
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