Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials Thomas R. Fleming, Bruce S. Weir, editors

Format:

Book

Conference/Event

Contributor:

Fleming, Thomas R.

Weir, B. S. (Bruce S.), 1943-

Conference Name:

Seattle Symposium in Biostatistics (4th : 2010 : Seattle, Wash.) http://viaf.org/viaf/293106203

Series:

Lecture notes in statistics (Springer-Verlag) 1205

Lecture notes in statistics 0930-0325 1205

Language:

English

Subjects (All):

Biometry--Congresses.

Biometry.

Genre:

proceedings (reports)

Conference papers and proceedings

Physical Description:

1 online resource

Place of Publication:

New York, NY Springer ©2013

Language Note:

English

System Details:

text file

PDF

Summary:

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

Contents:

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, 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, 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, Scott S. Emerson Genetic Markers in Clinical Trials B.S. Weir, P.J. Heagerty

Notes:

Includes bibliographical references

Other Format:

Print version:

ISBN:

9781461452454

1461452457

1461452449

9781461452447

9781283933957

1283933950

OCLC:

823304772

Access Restriction:

Restricted for use by site license