Key Features
* Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol
* Includes a chapter containing Case Histories
* Contains information on conducting clinical research within the pharmaceutical industry
* An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations
* Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Description
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.
Readership
Basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.
Writing Clinical Research Protocols, 1st Edition
Section I. The Basics: What You Need to Know Before Starting Human Subjects Research
- Introduction to the Art and Science of Clinical Research
- What You Need to Know About Clinical Research Ethics
- What You Need to Know About the Regulation of Clinical Research
Section II. Preparing the Protocol
- Designing a Clinical Research Study
- Selecting Subjects for Clinical Studies
- Risks and Benefits in Clinical Research
- Recruiting Subjects
- Informed Consent
- Privacy and Control
- The "Ethics" Section
Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping
- Procedures and Methods
- Statistics, Data Collection and Management, and Record Keeping
Section IV. Special Issues
- Use of Human Biological Materials
- Special Issues Raised by Evolving Areas of Clinical Research
- Case Histories: Learning From Experience
Appendix: Web Resources
References
Glossary
Index
Quotes and reviews
"This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today’s reality, and this book gives real insight into why and how."
- JAMA (February 2006)
