Assessing the Relationship Between Patient Centric Clinical Trial Practices, Pre- and Post-Approval Community Engagement Practices, and Vaccine Hesitancy and Adoption

We will use a mixed methods approach:

Quantitative Assessment

The purpose of the quantitative assessment is to map diffusion curves and to determine an empirical relationship between community-engagement activity, patient-centric clinical trial design, execution and communication and vaccine adoption experience.

The research team will build and analyze a dataset of relevant vaccines - those developed for infectious diseases impacting the general adult population -- approved by the Food and Drug Administration (FDA) since 2005. We will next map the diffusion of each of these vaccines at the national and regional level and identify 5 outliers that experienced significantly faster adoption.

Data on the pre-approval pivotal trials supporting these vaccines will be compiled from a proprietary database developed by the Tufts Center for the Study of Drug Development (Tufts CSDD). In 2020, Tufts CSDD compiled data on pivotal trials of all new drugs and biologics approved since 2007. Data was drawn and compiled from a number of sources in the public domain including the FDA, clinicaltrials.gov, and published articles in the literature. Detailed information about each pivotal trial supporting an approved drug or biologic - including drug information, pivotal trial scope and patient demographic data - was gathered. Since 2020, Tufts CSDD has continued to maintain and update this dataset.