Models for disease progression: new approaches and uses.

Disease-progression models are useful tools in drug development. They increase the information obtained from clinical trials, improve study designs, and allow in silico evaluations of new treatment combinations and dose regimens. Disease-progression modeling can save time and strengthen "go/no-go" criteria. The use of meta-based modeling and the linking of disease progression to discrete clinical end points have improved the utility of this valuable approach. This article provides an overview of disease-progression evaluations using these new approaches.