Class Central Tips
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.
We hope it inspires you to work in this exciting field.
Developed in collaboration with Johns Hopkins Open Education Lab.
Developed in collaboration with Johns Hopkins Open Education Lab.
