Learning Objectives
Upon successful completion of this course, the student will be able to identify types of research, research institutions, and personnel; discuss the various governmental regulations affecting research with respect to clinical trials, ethics, and cost constraints; and describe the basics of scientific methodology and the statistics of sampling, hypothesis testing, and data analysis.
Who Should Take This Course
Sales representatives, managers, and others who interact with healthcare professionals, including physicians, pharmacists, and nurses, and those who would benefit from learning more about how research is conducted.
Career Applications/Benefits
Without scientists performing research, most of the drugs available on the market today would never have been discovered. Pharmaceutical research also helps to clarify the risks and benefits associated with a particular therapy. While research is vital to the growth of the pharmaceutical industry, it is also a costly and highly regulated undertaking. Information provided in this course will allow individuals to understand how their company’s products were discovered and developed. In addition, representatives and others will be able to discuss clinical research and the drug development process with healthcare professionals who may have questions or concerns.
Chapter Content
Chapter One: Research—The Cornerstone of Medical Innovation
- American Innovation—The Research Environment
- Assuring the Quality of Research
- Forces that Drive Research Priorities
Chapter Two: Product Development and Patent Protection
- Key Terms
- The Preclinical Stages of Drug Development
- From Clinical Trials to NDA Approval
- Postmarketing Surveillance (Phase IV)
- Medical Device Development
- Patent Protection
- Re-engineering Clinical Research
Chapter Three: Research Design, Methodology, and Analysis
- The Scientific Method
- The Research Protocol
- A Closer Look at Experimental Designs
- Analyzing Study Data and Reporting Results
Chapter Four: Research Costs and Ethical Considerations
- The Costs and Financiers of Drug Development
- Ethical Protections in Drug Development
- Responding to Special Needs
- How Product Liability and Profitability Threaten R&D