دانلود کتاب کارآزمایی بالینی آمار زیستی و برنامه های بیودارویی
Clinical Trial Biostatistics and Biopharmaceutical Applications, 1ed
Since 1945, “The Annual Deming Conference on Applied Statistics” has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry.
Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data.
In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints.
This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.
“This book of timely, self-contained chapters covers a wide range of current methods and unresolved challenges in clinical trial statistical methods and will prove to be an essential guide for biostatisticians who work in this field.”
―Dirk F. Moore, Journal of Biopharmaceutical Statistics, ۲۰۱۵
Chapter 1: Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications
Chapter 2: Review of Randomization Methods in Clinical Trials
Chapter 3: First Dose Ranging Clinical Trial Design: More Doses? Or a Wider Range?
Chapter 4: Thorough QT/QTc Clinical Trials
Chapter 5: Controversial (Unresolved) Issuesin Noninferiority Trials
Chapter 6: Adaptive Designsin Drug Development
Chapter 7: Optimizing Group-Sequential Designs with Focus on Adaptability: Implications of Nonproportional Hazardsin Clinical Trials
Chapter 8: Group Sequential Designin R
Chapter 9: Issues in the Design and Analysis of Oncology Clinical Trials
Chapter 10: Competing Risks and Their Applicationsin Cancer Clinical Trials
Chapter 11: Dose Finding with Escalation with Overdose Controlin Cancer Clinical Trials
Chapter 12: Interval-Censored TJme-to-EventData and Their Applications in Clinical Trials
Chapter 13: Introduction to Multiple Test Problems, with Applications to Adaptive Designs
Chapter 14: Graphical Approaches to Multiple Testing
Chapter 15: Pairwise Comparisons with Binary Responses: Multiplicity-AdjustedP-Valuesand Simultaneous Confidence Intervals
Chapter 16: Comparative Study ofFive Weighted Parametric Multiple TestingMethods for Correlated Multiple Endpointsin Clinical Trials
Chapter 17: Statistical Analysisof Biomarkers from -Omics Technologies
Chapter 18: Understanding Therapeutic Pathways via Biomarkersand Other Uses of Biomarkersin Clinical Studies
Chapter 19: Statistical Evaluation of Surrogate Endpointsin Clinical Studies
لینک کوتاه : https://bookbaz.ir/?p=31676
نویسنده : Walter R. Young , Ding-Geng (Din) Chen
ناشر : Chapman and Hall/CRC; 1 edition
سال انتشار : 2014
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 574
(ISBN) شابک : 1482212188
قیمت کتاب درآمازون : $119.95
حجم فایل : 4 MB