Papers presented at the Fourth Seattle Symposium in Biostatics held on November 22 and 23, 2010 in Seattle, Wash.
Includes bibliographical references.
Biomarkers : role in the design and interpretation of clinical trials. The role and potential of surrogate outcomes in clinical trials : have we made any progress in the past decade? / David L. DeMets ; On the use of biomarkers to elucidate clinical trial results : examples from the women's health initiative / Ross L. Prentice and Shanshan Zhao ; On the use of biomarkers in vaccine research and development / Steven G. Self
Biomarkers : issues in individualized therapy. Recent developments in the use of clinical trials to support individualizing therapies : a regulatory perspective / Robert T.O'Neill ; Oncology clinical trials in the genomic Era / Richard Simon and Jyothi Subramanian ; Using SNPs to characterize genetic effects in clinical trials / B.S. Weir
Issues in multi-regional clinical trials. Why is this subgroup different from all other subgroups? : thoughts on regional differences in randomized clinical trials / Janet Wittes
Safety. Quantitative risk/benefit assessment : where are we? / Christy Chuang-Stein ; Identifying and addressing safety signals in clinical trials : some issues and challenges / Thomas R. Fleming ; Past, present, and future of drug safety assessment / Robert Temple
Special topics. Designing, monitoring, and analyzing group sequential clinical trials using the RCTdesign package for R / Daniel L. Gillen and Scott S. Emerson ; Genetic markers in clinical trials / B.S. Weir and P.J. Heagerty
Addresses for contact authors (in the same order as the papers).