Essentials of Clinical Research (Google eBook)
Stephen P. Glasser
Springer Science & Business Media, Jul 20, 2008 - Medical - 376 pages
This book is designed to provide the student interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.
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Chapter 3 Clinical Trials
Alternative Interventional Study Designs
The United States Federal Drug Administration FDA and Clinical Research
The Placebo and Nocebo Effect
Recruitment and Retention
Implementation Research Beyond the Traditional Randomized Controlled Trial
Research Methodology for Studies of Diagnostic Tests
Statistical Power and Sample Size Some Fundamentals for Clinician Researchers
Association Cause and Correlation
Bias Confounding and Effect Modification
Its All About Uncertainty
Chapter 19 Grant Writing
The Media and Clinical Research
adverse events allele analysis approach approval assess association baseline bias blood pressure cancer cardiovascular case-control study causal chapter Clin clinical research clinical trials cohort studies compared confounding control group controlled trials coronary discussed disease double-blind DSMB efficacy Epidemiology estimate ethical evaluate evidence example exposure factor frequency gene genetic haplotypes hypertension implementation research important improvement increase individual intervention investigators issues JAMA measure Medicine mentor meta-analysis methods monitoring multiple myocardial infarction null hypothesis observational studies occur odds ratio outcome p-value participants patients performed pharmacovigilance phase phenotype physician placebo controls placebo effect placebo group population postmarketing potential publication bias question randomized trials RCTs recruitment regression relative risk reported response rofecoxib safety sample selection significant SNPs specific standard statistical power study design subgroup subjects surrogate endpoints Table therapy tion treatment Type II error variable
Page 5 - The consequence was, that the most sudden and visible good effects were perceived from the use of the oranges and lemons ; one of those who had taken them, being at the end of six days fit for duty.