Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results
Bilcare Global Clinical Supplies is a global provider of Clinical Trial Materials (CTM) services
The European Clinical Trial Directive (EUCTD) - Webinar By GlobalCompliancePanel
E-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies
Latest Clinical Trial Trends In India
The effects of coffee consumption on lipid peroxidation and plasma total homocysteine concentrations: a clinical trial
South Korea Navigating the Clinical Trial and Regulatory Environment
Surging Clinical Trial Costs: Is There a Solution
South Korea: Navigating the Clinical Trial and Regulatory Environment
Implications Of Clinical Trial Processes
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. 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 sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease.
Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.
Use coupon below to get discount at eCampus.com!
$3 off textbook orders over $75
$4 off textbook orders over $90
$5 off textbook orders over $100
Copy the coupon code before clicking the button!
|Amazon US||Paperback||$75.10 - $99.95|
Randomized Clinical Trial and Therapeutic Decisions
Clinical Research Methodology and Evidence-Based Medicine: The Basics
Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical ...
Clinical Trial Simulations: Applications and Trends
Fundamental Concepts for Clinical Trial Statisticians
Arrhythmia Treatment and Therapy: Evaluation of Clinical Trial Evidence
Handbook of Phase II Clinical Trial Design
Hyperthermia and Cancer : Human Clinical Trial Experience
Recent Advances in Clinical Trial Design and Analysis
Multiple Sclerosis: Advances in Clinical Trial Design, Treatment and Future Perspectives