ESSENTIALS OF CLINICAL RESEARCH
Publisher: Springer
Publication Date: 2008
ISBN 13: 9781402084850
Edition: 1st
Description:
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. .
Table of Contents
Front Matter
Part I
- Introduction
- Ethical Issues
- Randomization
- Implications of Eligibility Criteria
- Efficacy vs Effectiveness
- Patient Compliance
- Recruitment and Retention
- Degree of Masking (Blinding)
- Selection of Comparison Groups
- Analytic Approach
- Losses to Follow Up
- Surrogate Endpoints
- Selection of Endpoints
- Trial Duration
- The Devil Lies in the Interpretation
- Conclusions
- References
- Introduction
- Traditional Versus Equivalence/Non-inferiority Testing
- The Null Hypothesis in Equivalence/Non-inferiority Trials
- N of 1 Trials
- Factorial Designs
- Case Crossover Design
- Externally Controlled Trials (Before-After Trials)
- Large Simple Trials (LSTs) and Prospective, Randomized, Open-Label, Blinded Endpoint Designs (PROBE)
- References
- Introduction
- FDA ‘Mandated or Negotiated’ Studies (Phase IV Studies)
- Practice Based Clinical Experience Studies
- Non FDA Studies
- Equivalence and non-inferiority trials are discussed in chapters 3 and 4 Large Simple Trials
- Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Design
- Surveillance Studies
- Drug Utilization and Pharmacoeconomic Studies
- Discussion
- Appendix
- References
Clinical Research: Definitions, “Anatomy and Physiology,” and the Quest for “Universal Truth” 1
Introduction to Clinical Research and Study Designs
Clinical Trials*
Alternative Interventional Study Designs
Postmarketing Research*
The United States Federal Drug Administration (FDA) and Clinical Research
The Placebo and Nocebo Effect
Recruitment and Retention
Data Safety and Monitoring Boards (DSMBs)
Meta-Analysis
Part II
- Important Principles of Genetics
- Units of Genetic Measure
- Terms and Basic Concepts in Genetic Epidemiology
- Biological Specimen
- Ethical, Legal and Social Implications (ELSI)
- Measurable Outcome and Phenotype
- General Methods in Clinical Genetic and Genetic Epidemiology Studies
- Candidate Gene vs. Genome-wide Association Studies
- Risk Quantification
- Additional Applications of Genetic Studies
- Major Issues and Limitations in Genetic Studies
- Concluding Remarks
- Recommended Readings
- References
- Selection of Study Design
- Study Designs Common in PE
- Descriptive Observational Studies
- Case Report
- Case Series
- Ecologic Studies
- Cross-Sectional Studies
- Analytical Studies
- Cross-Sectional Studies
- Case-Control Studies (or Case-Referent Studies)
- Cohort Studies
- Hybrid Studies
- Nested Case-Control Studies
- Case-Cohort Studies
- Case-Crossover Studies
- Case-Time-Control Studies
- Biases in PE
- Summary
- References
