Clinical Trial Methodology by Karl E Peace
Drawing from the authors' courses on the subject as well as the first author's more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and-
R for Health Technology Assessment
-
Value of Information for Healthcare Decision-Making
-
Bayesian Models in Health Technology Assessment
-
Statistical Methods for Immunogenicity Assessment
-
Randomization, Masking, and Allocation Concealment
-
Exposure-Response Modeling
-
Mixture Modelling for Medical and Health Sciences
-
Data Analysis with Competing Risks and Intermediate States
-
Statistics In the Pharmaceutical Industry
-
Design and Analysis of Bioavailability and Bioequivalence Studies
-
Mixed Effects Models for the Population Approach
-
Multiple Testing Problems in Pharmaceutical Statistics
-
Machine Learning for Microbiome Statistics
-
Master Protocol Clinical Trials for Evidence Generation
-
Does This Treatment Cause That Outcome?
-
Comparative Effectiveness and Personalized Medicine Research Using Real-World Data
-
Age-Period-Cohort Models
-
Biostatistics for Bioassay
-
Statistical Methods for Survival Trial Design
-
Every Coin Has Two Sides
-
Group Sequential and Adaptive Methods for Clinical Trials
-
Empirical Likelihood Method in Survival Analysis
-
Multiregional Clinical Trials for Simultaneous Global New Drug Development
-
Adaptive Design Methods in Clinical Trials
-
Clinical Trial Data Analysis Using R and SAS
-
Bayesian Cost-Effectiveness Analysis of Medical Treatments
-
Statistical Methods for Drug Safety
-
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
-
Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement
-
Meta-Analysis in Medicine and Health Policy
-
Model-Assisted Bayesian Designs for Dose Finding and Optimization
-
Statistical Methods in Drug Combination Studies
-
Design and Analysis of Clinical Trials for Predictive Medicine
-
Frailty Models in Survival Analysis
-
Bayesian Methods in Health Economics
-
Survival Analysis in Medicine and Genetics
-
Applied Surrogate Endpoint Evaluation Methods with SAS and R
-
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials
-
Design and Analysis of Animal Studies in Pharmaceutical Development
This comprehensive text introduces the key areas of clinical trial methodology from the perspective of the biostatistician in the pharmaceutical industry… Throughout, the text benefits from a highly structured and logical flow … the arguments made in the book are grounded in many years of practical experience in drug development and at the very least will act as a prompt for in-depth discussion or critical review of one’s own perceptions. … Clinical Trial Methodology will be of substantial value to early career pharmaceutical industry statisticians.
—Christopher J. Weir, Pharmaceutical Statistics, 2012
… informative discussions of mechanisms such as IND and NDA … are unique strengths of this book, distinguishing it from the many other clinical trial texts available. … Case studies … are presented carefully … The authors’ writing style is disciplined, careful, and informative. … this is a helpful and informative book, a nice reference to have for most biostatisticians working on clinical trials.
—Mithat Gönen, Journal of Biopharmaceutical Statistics, 21, 2011
The book is an excellent overview predicated on the first author’s seasoned experiences in designing, analyzing, and communicating the results of clinical trials across a broad number of medical disciplines. … A nice introductory feature is the history of drug law and regulation, which helps to frame the subsequent statistical discussion nicely. … The real-world examples that dominate the last few chapters are fantastic. … There is nothing like a series of examples from an experienced clinical trialist to whet the appetite of those involved in the noble enterprise of medical (and more specifically pharmaceutical) research with the goal of improving the public’s health. This book does an admirable job in giving the regulatory and statistical foundations for clinical trials, coupled with real-world examples of how statistical methodology has guided the
Karl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar, founding director of the Center for Biostatistics, and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.
Din Chen is the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.
| SKU | Unavailable |
| ISBN 13 | 9780367577155 |
| ISBN 10 | 0367577151 |
| Title | Clinical Trial Methodology |
| Author | Karl E Peace |
| Series | Chapman And Hall Crc Biostatistics Series |
| Condition | Unavailable |
| Binding Type | Paperback |
| Publisher | Routledge |
| Year published | 2020-06-30 |
| Number of pages | 420 |
| Cover note | Book picture is for illustrative purposes only, actual binding, cover or edition may vary. |
| Note | Unavailable |