Course Overview

SCI-401: Pharmaceutical and Medical Research (3 Credits)
Program(s): CMR

COURSE CONSULTANTS

SEVENTH AND EIGHTH EDITIONS:

Thomas S. Foster, PharmD, FCP, FAPHA, FCCP
Professor of Pharmacy and
Anesthesiology
Colleges of Pharmacy and Medicine
University of Kentucky
Medical Center
Lexington, Kentucky

Scott A. Waldman, MD, PhD, FCP
Samuel M.V. Hamilton Professor

Chair, Department of Pharmacology and Experimental Therapeuties

Director, Division of Clinical
Pharmacology
Department of Medicine
Thomas Jefferson University
Philadelphia, Pennsylvania

Graduate Supplement
SCI-5401
To earn graduate-level credit, this supplement and course SCI-401 must be successfully completed.

Click here for more information about graduate-level credit.

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.

Course Description:
This course describes the different types of research, research institutions, and personnel in the industry. It also describes the various governmental regulations affecting research with respect to clinical trials, ethics, and cost constraints. In addition, this course describes the scientific method, research design, and the statistics of sampling, hypothesis testing, and data analysis.

Related Courses:
• Applications of Evidence-Based Medicine
• Medical Ethics
• The Pharmaceutical Industry

Chapter Content:

Chapter 1: Research-The Cornerstone of Medical Innovation
	American Innovation—The Research Environment Assuring the Quality of Research Forces that Drive Research Priorities
Chapter 2: 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 3: Research Design, Methodology, and Analysis
	The Scientific Method The Research Protocol A Closer Look at Experimental Designs Analyzing Study Data and Reporting Results
Chapter 4: 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

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.