Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials [electronic resource] /
Seattle Symposium in BiostatisticsCorporate Author
Seattle Symposium in Biostatistics(4th :2010 ;Seattle, Washington)
Seattle Symposium in Biostatistics
Fleming, Thomas R.editor.
Weir, Bruce S.editor.
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.
Description based upon print version of record.
Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials; Preface; Contents; 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?; 1 Introduction; 2 Basic Requirements for a Potential Surrogate; 3 Some Earlier Examples; 4 Lipid-Lowering Interventions; 5 Other Recent Examples; 6 Summary; References; On the Use of Biomarkers to Elucidate Clinical Trial Results: Examples from the Women's Health Initiative; 1 Introduction
2 Biomarkers and Variations in Clinical Trial Intervention Effects3 Biomarkers of Intervention Adherence and Exposure; 4 Biomarkers as Mediators of Clinical Trial Intervention Effects; 5 Biomarkers for Intervention Development; 6 Discussion and Summary; References; On the Use of Biomarkers in Vaccine Research and Development; 1 Introduction; 2 Immune Response to Vaccines; 3 Presence and Specificity of the Target Pathogen; 4 Summary; References; Part II Biomarkers: Issues in Individualized Therapy
Recent Developments in the Use of Clinical Trials to Support Individualizing Therapies: A Regulatory Perspective1 Introduction; 2 A Definition of Individualized Therapy; 3 A Rich Statistical History of Modeling and Identifying Risk Factors Associated with Differential Outcomes: Response Or Risk; 4 Prediction and Predictive Factors in Randomized Clinical Trials; 5 A Related Topic: Dealing with Differential Treatment Response Associated with Ethnic Factors: The Role of the ICH E5 Guidance on Acceptance of Foreign Clinical Data
6 Some Recent Examples of Treatment Effects Related to Individual Or Patient Level Covariates7 Replication of Results of Differential Treatment Effects in Enriched and Non-Enriched Subpopulations: Why?; 8 Potential Impact of Prognostic Factor Imbalances in Retrospectively Identified Treatment/Marker Subgroups; 9 Genetic Changes Over the Course of Treatment Or Disease Progression: Impact on Inferences and Design; 10 Study Designs to Evaluate Targeted Therapy; 11 Summary; References; Oncology Clinical Trials in the Genomic Era; 1 Introduction; 2 Targeted (Enrichment) Designs
3 Biomarker Stratified Design4 Designs That Evaluate a Small Number of Classifiers; 5 Predictive Analysis of Clinical Trials; 6 Conclusion; References; Using SNPs to Characterize Genetic Effects in Clinical Trials; 1 Introduction; 2 SNP Data; 3 Cleaning SNP Data; 3.1 SNP-Level Cleaning; 3.2 Individual-Level Cleaning; 4 Association Testing; 5 HLA Typing; 6 Discussion; References; 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; 1 Introduction
2 Why Involve Participants from Many Countries?
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.
Statistics .
Statistics, general.
Statistics for Life Sciences, Medicine, Health Sciences.