Chapman and Hall/CRC
An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.
"This is a timely text. The number of published studies using surrogate endpoints has increased dramatically since the early work of the 1980s; however, there is a dearth of available texts or software on this topic. Anyone with an interest in surrogate endpoint evaluation would benefit from this text."
~Statistics in Medicine
Introductory Material. Introduction. Notation and Example Datasets. The History of Surrogate Endpoint Validation. Contemporary Surrogate Endpoint Evaluation Methods. Multiple-Trial Surrogate Endpoint Evaluation Methods. Two Continuous Outcomes. Two Survival Endpoints. Two Categorical Endpoints. A Categorical and a Continuous Endpoint. A Survival and a Continuous Endpoint. A Survival and a Categorical Endpoint. Two Longitudinal Endpoints. A Longitudinal and a Survival Endpoint. Additional Considerations and Further Topics. Software Details. An Alternative Surrogate Endpoint Evaluation Framework: Causal-Inference. Surrogate Endpoint Evaluation Methods in Small Samples. Construction and Evaluation of Genetic Biomarkers in Early Drug Development Experiments. Additional Considerations.