trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does...

powered. Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is...

functions Gradient-enhanced kriging (GEK) OptiY Space mapping Surrogate endpoint Surrogate data Fitness approximation Computer experiment Conceptual model...

measure that a drug is effective in treating the desired disease, and a surrogate endpoint is used to guide whether or not it is appropriate to proceed with...

analysis of a surrogate endpoint at month twelve in a 54-month, randomized, double-blind placebo-controlled trial. The surrogate endpoint measured the...

before being brought to clinical trials. Some ideal characteristics of surrogate endpoint biomarkers include: Biomarker should be involved in process that causes...

artist Allan McCollum Surrogate model, used in engineering design Surrogate endpoint, a measure of effect in clinical trials Surrogate key, a unique database...

surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints...

faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit...

outcome measures. Outcome measures can be divided into clinical endpoints and surrogate endpoints where the former is directly related to what the goal of the...

supernatural Survivorship bias – Logical error, form of selection bias Surrogate endpoint – Biomarker proxy outcome measure Texas sharpshooter fallacy Woods...

can are detected clinically. The biomarkers act as surrogate endpoints. The use of surrogate endpoints has been shown to significantly decrease the time...

clinical endpoints are very costly as they have long durations and tend to need large numbers of patients. In contrast to clinical endpoints, surrogate endpoints...

cardiovascular events. As such, the use of change in carotid IMT as a surrogate endpoint measure of drug efficacy in clinical trials, or in clinical management...

intervals compared to baseline observations. CTCs are a potential surrogate endpoint in oncology trials, with reduced levels suggesting long-term clinical...

States Food and Drug Administration approved DAAs on the basis of a surrogate endpoint called sustained virological response (SVR). SVR is achieved in a...

gives separate definitions and prefers PFS. PFS is widely used as a surrogate endpoint in oncology. The definition of "progression" generally involves imaging...

ozogamicin (trade name: Mylotarg) was approved based on a study with a surrogate endpoint, through the accelerated approval process. In June 2010, after evidence...

standard chemotherapy. The accelerated approval was based on the surrogate endpoint of response rate. It was the first antibody-drug conjugate to be approved...

reduction in the level of the biomarker alkaline phosphatase as a surrogate endpoint for clinical benefit. It is indicated for the treatment of primary...

Treatment Interventions "Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation...

after 48 weeks of treatment with the drug or longer. The change was a surrogate endpoint and the trial did not establish clinical benefit of the drug, including...

composite endpoints while performing relative effectiveness assessments. EUnetHTA: Endpoints used in Relative Effectiveness Assessment Surrogate Endpoints. This...

2012. Fauber J, Chu E (27 October 2014). "The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy?". MedPage Today. "Inlyta : EPAR - Product Information"...

Biomarkers Definitions Working Group (March 2001). "Biomarkers and surrogate endpoints: preferred definitions and conceptual framework". Clinical Pharmacology...

2 diabetes, as measured by glycated haemoglobin A1c (HbA1c) as a surrogate endpoint, similar to that of other oral antidiabetic drugs. The controversy...

potential as an ALS biomarker (also known as a biological correlate or surrogate endpoint) by Prize4Life, a 501(c)(3) nonprofit organization dedicated to accelerating...

(FDA) approves cancer therapies on the basis of arbitrarily assigned surrogate endpoints that typically have no bearing on overall survival or quality of...

chemopreventive agents, in people and in animals. The relevance of ACF as a surrogate endpoint biomarker for cancer is controversial. Recently, several alternative...

meet the primary endpoint. While imaging studies had shown that aducanumab did reduce amyloid plaque buildup, a surrogate endpoint for Alzheimer's treatment...