Biomarkers and surrogate endpoints. Clinical research and applications

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.

Foreword. Keynote Addresses. (H. Varmus, J. Henney) Toward a structured national program to speed the invention and development of new technologies for measuring the progression of chronic diseases (J.F. Niblack). Biomarkers and Surrogate Endpoints in Clinical Research: Definitions and Conceptual Model. Plenary Sessions. Plenary Session 1: Historical Perspectives. Biomarkers as surrogate endpoints in clinical trials for HIV/AIDS: A model for other diseases? D. Mildvan). Biomarkers for HIV/AIDS: challenges ahead (J.M. Kagan). Biomarkers as Surrogates in Clinical Research (S.L. Zeger). Plenary Session 2: The Need and Prospects for Biomarkers in Therapeutic Development. Contribution of pharmacology markers (P. Rolan). The importance of markers in drug discovery and development (M.B. Silber). Prospective search for AD biomarkers (T. Sunderland). Use of modern proteomics to discover protein biomarkers of disease (R. Parekh). The early detection cancer research network (R.D. Klausner). Plenary Session 3: Opportunities for Developing Biomarkers for Central Nervous System Disorders. Biomarkers for the experimental therapeutics of Huntington's disease and Parkinson's disease (I. Shoulson). Imaging the addicted brain (N.D. Volkow). Cognitive biomarkers and the treatment of schizophrenia (B.A. Cornblatt). Genetic and epidemiologic basis for developing biomarkers of complex diseases (K.R. Merikangas). Plenary Session 4: Immune and Inflammatory Markers. Introduction and Overview. (A. Fauci). Immune memory and protective immunity (R. Ahmed). Seeing is believing: monitoring in vivo gene expression by magnetic resonance imaging (T.J. Meade). Gene expression in inflammatory disease using multiple DNA array technologies (D.H. Mack). Challenges in discovery of useful biomarkers (G. Ringold). Plenary Session 5: Emerging Technologies: Insight Into Novel Biomarkers. From ambiguities to insights (D.J. Lipman). Emergent order in systematic genome-scale observations in variation in gene expression patterns and its implication for diagnosis and surveillance (P.O. Brown). cDNA approaches to analysis of human disease (J.H. Eberwine). SAGE and expression technologies-potential biomarker applications (G. Riggins). Breakout Sessions. Neurosciences 1.- Neurodegenerative and Neuropsychiatric Disorders (I. Shoulson, L.S. Brady). Neurosciences 2.- Biomarkers for Alcohol and Drug Abuse (E.D. London, F. Vocci). Neurosciences 3.- Biomarkers for Pain Assessment (G. Fischbach, H. Slavkin, C. Kitt). Biomarkers for Chronic Lung Diseases (S. Buist). Pharmacokinetic and Pharmacodynamic Methods in Biomarker Development and Application (S.C. Piscitelli, C.C. Peck). Biomarkers of Toxicity and Surrogate Endpoints for Safety (F.D. Sistare, J.D. Morrow, P. Clax). Biomarkers in Cardiovascular Diseases (G. Sopko, L. Friedman). Cardiovascular 1.- Acute Ischemic Coronary Syndromes (J. Hochman,. Dzau). Cardiovascular 2.- Stable Cardiovascular Disease (R. Califf, R.S. Balaban). Biomarkers for Transplantation (W. Harmon et al.). Cancer Prevention - Biomarkers and Surrogate Endpoints in Clinical Trials (E.R. Greenberg, W. Ki Hong). Biomarkers in Cancer Therapeutics (A.F. LoBuglio, J.M. Pluda, P. Ivy). Biomarkers of Severe Infections and Septic Shock (T.R. Martin, A.F. Suffredini). Biomarkers in the Spectrum of Autoimmune Diseases (D.S. Pisetsky, E. Collier). Biomarkers of Osteoporosis (S.R. Cummings, S. Sherman, J. McGowan). Biomarkers of Joint Destruction and Repair (K.D. Brandt, S. Serrate-Sztein). Establishing the Research Infrastructure to Develop and Classify

Perfect for clinical investigators from a broad range of disciplines, therapeutic and diagnostic developers, public health organizations, contract research organizations, researchers from pharmaceutical and biotechnology industries