Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials (Lecture Notes in Statistics Book 1205)

This volume contains a selection of chapters base on papers presented at the Fourth Seattle Symposium in Biostatistics: Clinical Trials. The symposium was held in 2010 to celebrate the 40th anniversary of the University of Washington School of Public Health and Community Medicine. It featured keynote lectures by David DeMets and Susan Ellenberg and 16 invited presentations by other prominent researchers. The papers contained in this volume encompass recent methodological advances in several important clinical trials research, such as biomarkers, meta-analyses, sequential and adaptive clinical trials, and various genetic bioinformatic techniques. This volume will be a valuable reference for researchers and practitioners in the field of clinical trials. This volume contains a selection of chapters based on papers presented at the Fourth Seattle Symposium on Biostatistics: Clinical Trials. These biostatistical symposiums, which unite leading researchers every five years, represent important developments in field. The Fourth Seattle Symposium was held in 2010 to celebrate the 40th anniversary of the University of Washington School of Public Health and Community Medicine. The Symposium featured keynote lectures by Robert O'Neill, Ross Prentice and Robert Temple, as well as invited talks by Jesse Berlin, Christy Chuang-Stein, David DeMets, Bill DuMouchel, Susan Ellenberg, Thomas Fleming, Laurence Freedman, Margaret Pepe, Steve Self, Richard Simon, Bruce Weir, John Whittaker and Janet Wittes. Invited panelists included Jesse Berlin, Bruce Binkowitz, Christy Chuang-Stein, Bill DuMouchel, Susan Ellenberg, Thomas Fleming, Henry Fuchs, Dominic Labriola, Robert O'Neill, Robert Temple and Janet Wittes. The thoroughly peer-reviewed papers and material from short courses that are showcased in this volume represent the theme of the symposium, clinical trials. These papers encompass recent methodological advances on several important topics, summaries of the state of the art of methodology in key areas of clinical trials, as well as innovative applications of the existing theory and methods. This volume will be a valuable reference for researchers and practitioners in the field of clinical trials Front Matter....Pages i-viii Front Matter....Pages 1-1 The Role and Potential of Surrogate Outcomes in Clinical Trials: Have We Made Any Progress in the Past Decade?....Pages 3-19 On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women’s Health Initiative....Pages 21-33 On the Use of Biomarkers in Vaccine Research and Development....Pages 35-46 Front Matter....Pages 47-47 Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective....Pages 49-62 Oncology Clinical Trials in the Genomic Era....Pages 63-79 Using SNPs to Characterize Genetic Effects in Clinical Trials....Pages 81-91 Front Matter....Pages 93-93 Why Is This Subgroup Different from All Other Subgroups? Thoughts on Regional Differences in Randomized Clinical Trials....Pages 95-115 Front Matter....Pages 117-117 Quantitative Risk/Benefit Assessment: Where Are We?....Pages 119-135 Identifying and Addressing Safety Signals in Clinical Trials: Some Issues and Challenges....Pages 137-156 Past, Present, and Future of Drug Safety Assessment....Pages 157-173 Front Matter....Pages 175-175 Designing, Monitoring, and Analyzing Group Sequential Clinical Trials Using the RCTdesign Package for R....Pages 177-208 Genetic Markers in Clinical Trials....Pages 209-245 Back Matter....Pages 247-249