an alternative measure for meta‐analytic surrogate endpoint ...

The Statistical Evaluation of Surrogate Endpoints in Clinical Trials

A biomarker that is intended to substitute for a clinical endpoint. A ... meta-analytic setting. • Prediction: useful in a new trial. The Statistical ...

Assessment of the information theory approach to evaluating time-to ...

Surrogate threshold effect: An alternative measure for meta- analytic surrogate endpoint validation. Pharmaceutical Statistics 2006; 5:173 ...

Clinical Trial Endpoints for the Approval of Cancer Drugs and ... - FDA

Cancer Drugs and Biologics, regarding tumor measurement data collection and PFS analysis also apply more broadly to oncology endpoints and should be used in ...

Surrogate endpoints for overall survival in randomized clinical trials ...

Meta-analyses of the treatment effect measures were conducted using random effects models. A weighted linear regression (WLS) model was used ...

Dossier 7 - Les surrogates endpoints , Références

Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation. ... surrogate endpoints. Biometrical Journal 2016;58 ...

Demonstrating Efficacy via Surrogate Endpoints

The validation of surrogate endpoints in meta-analyses ... Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation.

Informed decision-making: statistical methodology for surrogacy ...

Surrogate threshold effect: An alternative measure for meta-analytic surrogate endpoint validation. Pharmaceutical Statistics 2006;5:173-86. 25. van ...

Surrogate endpoints: when to use and when not to use? A critical ...

Level 3: A substitute outcome not validated, but which is reasonably capable of indicating clinical benefit and;. Level 4: A correlation that is only measure of ...

A perspective on surrogate endpoints in controlled clinical trials

surrogate endpoint: a biomarker that is intended to substitute for a clinical ... On meta-analytic assessment of surrogate outcomes. Biostatistics 2000; 1 ...

Analysis Suggests Additional Evidence Necessary for Surrogate ...

... surrogate markers, such as imaging findings or laboratory measures, as primary endpoints. ... meta-analysis, few reported high-strength ...

Challenges and Opportunities in Establishing Appropriate ...

1 What is a surrogate endpoint, what do we expect from it, and what are the challenges? The search for appropriate intermediate endpoints that can be used as ...

A Surrogate Measure for Time-Varying Biomarkers in Randomized ...

... endpoint by an earlier and more easily accessible alternative endpoint. A surrogate marker in clinical trials is considered to be “a laboratory measurement ...

Meta-Analytic Approach to Evaluation of Surrogate Endpoints | 20

A surrogate endpoint is intended to replace a clinical endpoint for the evaluation of new treatments when it can be measured more cheaply, more conveniently ...

Retinal Patterns and the Role of Autofluorescence in Choroideremia

... outcome measures, such as autofluorescence, as a surrogate for retinal sensitivity. ... In a recent meta-analysis, Shen et al. looked at the long-term ...

Use of Surrogate Endpoints in Oncology - YouTube

... Surrogate Endpoints Speaker: Nicole Gormley, MD Summary: This case study reviews the use of meta-analysis methods to assess the suitability ...

The DEM Method for Evaluating Surrogate Endpoints for ... - YouTube

The Decision-Equivalence Metric (DEM) method for Evaluating Surrogate Endpoints for Accelerated Clinical Development Using a Combination of ...