Learn the entire clinical trial process

Phase I to III clinical trials

As you study with leaders in the global biopharmaceutical and medical device industries, many of whom are discovering new treatments and health products every day, you¡¯ll gain a practical understanding of the scientific principles, current regulations, and ethical issues underlying clinical research.

You will gain an understanding of how to bring a new drug to market approval¡ªfrom the discovery of a potential drug molecule and evaluation in the laboratory to clinical trials with human volunteers and FDA oversight processes, including the principles of Good Clinical Practice.

• The impact of drug patents on pharmaceutical pricing for new drugs
• The underlying science that drives clinical trial design
• Statistical considerations and the kind of information obtained from trials
• FDA regulations that govern clinical trials
• Bioethics related to the treatment of human subjects participating in clinical trials
• Basic concepts related to drug safety

Certificate learning outcomes

• Demonstrate an understanding of the mechanics and key regulatory requirements of conducting a clinical trial to evaluate the safety and efficacy of an investigational drug in human volunteers.
• Have an awareness and rudimentary understanding of the technologies that biopharmaceutical companies employ to discover and evaluate the pharmacological activities of potential new drug molecules.
• Know the key players involved in drug discovery and development:
  • Biopharmaceutical companies;
  • Contract research organizations; and
  • Clinical sites conducting Phase I through Phase III studies.
• Understand the role of key oversight organizations
  • U.S. Food and Drug Administration in the context of Good Clinical Practice;
  • Relevant Title 21 Code of Federal Regulations; and
  • International Conference of Harmonization Guidelines in the conduct of clinical studies.
• Assess how clinical trials are designed specific to different therapeutic areas.
• Identify the role biostatistics plays in designing the clinical protocol and evaluating the resulting safety and efficacy data.