- Please identify from the literature a trial that may be considered to be a pragmatic trial.
Identify and describe THREE features of that trial that make this pragmatic (include the
relevant text from the articles for support and provide the reference). (5 pts) – Not
exceed 500 words - Please identify in the literature a study that used propensity score methodology in an
investigation of the harms of a medication. (5 pts) – Not exceed 500 words
a. Were there baseline differences between the exposure groups that might cause
confounding? Give me an example and explain confounding in your response.
b. Describe how the authors used the propensity score to reduce confounding (not
how they generated the propensity score). Tell me whether it is likely or not that
they overcame confounding.
Part B. (10 pts)
- York Vaccines, your employer, has developed a new sars-COV2 vaccine called HopiVax. It
is recommended for use in nursing home residents and dormitory residents (college
students, military, imprisoned people). FDA approved HopiVax as it was able to elicit a
good antibody response and demonstrated good efficacy in the phase III studies.
FDA is requiring that York Vaccines develop a registry that will be initiated as soon as it
begins distributing product, as they want to evaluate risks. Please describe to the FDA
your plans for establishing this registry. Please focus on the population, recruitment,
data you will collect, and how you will use the registry to inform the regulation of the
vaccine [as this is why FDA is asking you to do this.]