Biomarkers and surrogate end points have great potential for use in clinical oncology, but
their statistical validation presents major challenges, and few biomarkers have been robustly …

Multiple sclerosis is a complex disease, as several pathophysiological processes (including
inflammation, demyelination, axonal damage and repair mechanisms) participate in the …

The idea for this book came from the time the authors spent at the Statistics and Applied
Mathematical Sciences Institute (SAMSI) in Research Triangle Park in North Carolina …

Meta-analysis is the application of statistics to combine results from multiple studies and
draw appropriate inferences. Its use and importance have exploded over the last 25 years …

Both humanitarian and commercial considerations have spurred intensive search for
methods to reduce the time and cost required to develop new therapies. The identification …

Background Treatment of advanced colorectal cancer has progressed substantially.
However, improvements in response rates have not always translated into significant …

Background An intermediate endpoint is hypothesized to be in the middle of the causal
sequence relating an independent variable to a dependent variable. The intermediate …

Many candidate surrogate endpoints are currently assessed using a 2-level statistical
approach, which consists in checking whether (1) the potential surrogate is associated with …

Before a surrogate end point can replace a final (true) end point in the evaluation of an
experimental treatment, it must be formally 'validated'. The validation will typically require …

A central goal of vaccine research is to identify a vaccine-induced immune response that
predicts protection from infection or disease. The term" correlate of protection" has been …