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.
Author(s): David L. DeMets (auth.), Thomas R. Fleming, Bruce S. Weir (eds.)
Series: Lecture Notes in Statistics 1205
Edition: 1
Publisher: Springer-Verlag New York
Year: 2013
Language: English
Pages: 249
Tags: Statistics, general; Statistics for Life Sciences, Medicine, Health Sciences
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
