Description
Book SynopsisExamines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients.
Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research.
Documents Alternative Research Approaches for Faster and More Accurate Data Judgment CallsElaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts.
This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.
Trade Review"This is one of the few books published on the strategies for TM. The chapters are carefully coordinated and can be read on their own; they are independent but are still well coordinated. The book contains a good outline of the different aspects of TM and contains a series of good examples. ... this book will provide interesting reading for readers from a variety of backgrounds. Overall, this book contains a good foundation for anyone working in this area." -Richardus Vonk, Pharmaceutical Statistics "... chapters follow the natural order from discovery research to final implementation to intermediate validation." -Erik Cobo, International Society for Clinical Biostatistics
Table of ContentsTranslational Medicine: Strategies and Statistical Methods. Strategic Concepts in Translational Medicine. Design and Analysis Approaches for Discovery Translational Medicine. Biomarker Development. Targeted Clinical Trials. Statistical Methods in Translational Medicine. NonparametricMethods in Translational Research. Model Selection/Validation. Translation in Clinical Information between Populations—Bridging Studies. Translation in Clinical Technology—Traditional Chinese Medicine. Index.
