| dc.description.abstract | During the vaccination stages of the COVID-19 pandemic, researchers used varied study designs to
conduct vaccine safety studies. This highlighted the diversity in study designs used by researchersand
variance in the results they found, even when their aims were similar. These experiences suggest that
establishing a uniform approach in vaccine safety study designs is imperative. This uniformity is vital
in providing policymakers with informed guidance regarding vaccine safety quicker and is essential
for pandemic preparedness. Our objective is to assess and contrast the applicability of a cohort study
versus a self-controlled study design. This comparative analysis aims to pave the way for establishing
cohesive and consistent methodologies in future vaccine safety investigations.
To accomplish this aim, we propose a Monte Carlo simulation study. We will generate data for two
scenarios. The first scenario reflects parameters strongly linked to the outcome of interest, while the
second dataset features a randomly distributed prevalence of the outcome within the sample. We will
include the parameters age, sex, follow-up time, type of vaccine, number of doses, and unmeasured
confounding, to emulate real world data challenges both the study designs face. This data will be
analysed in a substantive analysis for bias of the association paramters age, sex, follow-up time, type
of vaccine, number of doses, and the unmeasured confounder.
The proposed research will span two years, involving tasks such as code writing, code checks, data
analysis, internal peer review, and report writing. We have identified potential alternatives to address
any challenges that may arise during our planning and research. | |
