Vaccines are evaluated through a series of clearly defined controlled studies to assess these investigational products for safety, immunogenicity and efficacy before they are approved for licensure. All clinical vaccine trials are bound by international ethical guidelines and, in the case of US trials, Food and Drug Administration (FDA) regulations.
Good Clinical Practice is defined by the International Conferences on Harmonization (ICH) as: “A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.”
That’s a tall order, so how is it done? Individuals who enroll as subjects in these trials play an essential role in the development and evaluation of new and improved candidate vaccines. They are average citizens who volunteer to roll up their sleeves and, in the process, make a tremendous difference in society. So why do they volunteer and what safeguards do we put in place to protect their rights, safety and well-being while in the trial? What are the responsibilities of the investigators, sponsors and ethics committees who conduct and oversee these trials?
Along with our colleagues, we will introduce you to how GCP is applied in clinical vaccine trials to ensure proper and ethical scientific conduct. The course will use examples from real vaccine trials to demonstrate the application of the FDA Code of Federal Regulations and ICH GCP Guidelines to explore methods and best practices involved in implementing phase I and II vaccine clinical trials. This short course offering through Coursera is based on our work at the Center for Immunization Research and an in-depth graduate course taught at the Johns Hopkins Bloomberg School of Public Health.