Description

Clinical research is part of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. This course will provide a comprehensive overview of clinical research that includes study designs, various phases of clinical trials, protocol development, responsibilities of clinical research staff, regulatory issues and the role of the Food and Drug Administration (FDA).

Pre-requisite

This is the start point for those who would like to be introduced to the area of global clinical research.

Learning Outcomes

At the conclusion of the course, participants will be able to have a good understanding of

• Clinical research study designs and principles involved in various phases of clinical trials
• Drug development process
• Regulatory issues and the role of FDA in the drug approval process

Topics of Study

Topics include an in-depth instruction of the following:

• Priniciples of clinical research study design and various phases of clinical trials.
• Drug development processes, the principles of good clinical practice, the key personnel in clinical research, and medical terminology.
• Responsibilities of personnel (clinical research associates (CRAs), data coordinators and data entry staff, investigators, biostatisticians, etc.) within clinical trials.
• Scientific, ethical and legal aspects of clinical trials.
• Creation of a protocol and mechanism to assure patient safety, including the protection of human rights, global product safety, IRBs and tracking and reporting of adverse events.
• Other topics that include randomization, blinding procedures, roles of the Food & Drug Administration (FDA) and the International Conference on Harmonization (ICH).
• Approaches to public health regulation. Examples will come primarily from the United States because US has such a pervasive influence on the international stage. Public health regulation traditionally covers water, sanitation, air, food, medicines, and a large array of consumer products. The US Food and Drug Administration will be discussed in detail.