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E-raamat: Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials

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  • Formaat: PDF+DRM
  • Sari: Lecture Notes in Statistics 1205
  • Ilmumisaeg: 12-Dec-2012
  • Kirjastus: Springer-Verlag New York Inc.
  • Keel: eng
  • ISBN-13: 9781461452454
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Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical TrialsSuurem pilt
  • Formaat: PDF+DRM
  • Sari: Lecture Notes in Statistics 1205
  • Ilmumisaeg: 12-Dec-2012
  • Kirjastus: Springer-Verlag New York Inc.
  • Keel: eng
  • ISBN-13: 9781461452454
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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.
Preface v
Part I 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?
3(18)
David L. DeMets
On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women's Health Initiative
21(14)
Ross L. Prentice
Shanshan Zhao
On the Use of Biomarkers in Vaccine Research and Development
35(14)
Steven G. Self
Part II Biomarkers: Issues in Individualized Therapy
Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective
49(14)
Robert T. O'Neill
Oncology Clinical Trials in the Genomic Era
63(18)
Richard Simon
Jyothi Subramanian
Using SNPs to Characterize Genetic Effects in Clinical Trials
81(14)
B.S. Weir
Part III Issues in Multi-Regional Clinical Trials
Why Is This Subgroup Different from All Other Subgroups? Thoughts on Regional Differences in Randomized Clinical Trials
95(24)
Janet Wittes
Part IV Safety
Quantitative Risk/Benefit Assessment: Where Are We?
119(18)
Christy Chuang-Stein
Identifying and Addressing Safety Signals in Clinical Trials: Some Issues and Challenges
137(20)
Thomas R. Fleming
Past, Present, and Future of Drug Safety Assessment
157(20)
Robert Temple
Part V Special Topics
Designing, Monitoring, and Analyzing Group Sequential Clinical Trials Using the RCTdesign Package for R
177(32)
Daniel L. Gillen
Scott S. Emerson
Genetic Markers in Clinical Trials
209(38)
B.S. Weir
P.J. Heagerty
Addresses for Contact Authors (in the same order as the papers) 247
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