Biomarkers and Surrogate Endpoints: Clinical Research and Applications: Proceedings of the NIH-FDA Conference, Bethesda, MD, 15-16 April 1999, ICS 1205, 1e (International Congress)

The potential adaptation of biomarkers as substitutes for clinical endpoints, or surrogate endpoints, in clinical trials has recently taken on new importance. This volume summarizes the proceedings of the first international, multi-disciplinary conference held to discuss this important issue. A historical perspective is provided on the use of biomarkers in drug development, as diagnostic and clinical measuring tools, and in some cases their application as surrogate endpoints in diseases such as AIDS, cancer, and cardiovascular disease. Also included is a review of concepts, terminology, and examples which provide a background for those who are not familiar with the use of biomarkers in drug development and clinical trials.

There is presently no other publication which gives such a unique insight into the current state of understanding of biomarkers for specific disease areas, and the emerging tools and technologies that may be used to discover and evaluate biomarkers. The book also focuses on areas of need or interest in identifying new biomarkers, and key issues for researchers in applying them in drug development and clinical trials.