Prepare a paper that defines each clinical trial concept in your own words and explains how each concept was demonstrated within the FDA application process and trials.
The concepts that should be covered are:
Randomized
Blinded
Placebo-controlled
Stratification
Immunogenicity
Primary efficacy endpoint
Secondary efficacy endpoint
Cumulative incidence curve
Imagine you are member of the FDA review committee, consider the strengths and weaknesses of the clinical trial you reviewed.
Is there convincing evidence that the vaccine candidate should be approved for emergency use authorization? Cite evidence from the application to support your assertion.
What concerns do you have about the results of the clinical trial that you think need to be addressed before conferring approval?
Be sure to properly cite and reference all supporting literature. Please ensure all references are current and published within the past five (5) years.
Please use the following headings:
Introduction
Concepts Covered For Pfizer Vaccine
Strengths and Weaknesses of the Clinical Trial
Vaccine Candidate Approved for Emergency Use
Concers About Results Before Conferring Approval
Conclusion
References
Please review the rubric in the assignment pdf file as well. The learning resources are attached if references are needed.
