Year: 2015-16

Company: Pfizer

Liaison(s): Greg Adams Bonnie Vlahos

Pfizer Inc., a global biopharmaceutical company
founded in 1849 by Charles Pfizer and Charles F.
Erhart, is headquartered in New York, NY. Pfizer’s
mission is to apply science and technology to
improve the health and well-being of people at all
stages of life through the discovery, development,
and manufacturing of healthcare products. Pfizer’s
commercial operations are comprised of a wide
portfolio of medical products across therapeutic
areas including immunology, oncology, cardiology,
endocrinology, and neurology.
Research has shown that varying demographic
subgroups respond differently to pharmaceutical
products. However the safety and efficacy data
presented to the FDA during the drug approval process
is derived from clinical trials where the vast majority
of participants are older Caucasian males. In response
to this disparity, the FDA released the Food and Drug
Administration Safety and Innovation Act (FDASIA)
in 2012. This states that the inclusion of diverse
patient populations in clinical trials is required for
the approval of new medical products. The FDASIA
was issued to make medical products safer and
more effective for different demographic groups and
encourages pharmaceutical companies to investigate
how well various demographic subgroups respond to
their products.
The TMP team, in collaboration with Pfizer’s Diversity
in Clinical Trials Initiative Team, focused on improving
the inclusion of diverse patient populations in two
of Pfizer’s ongoing clinical trials. The project’s main
objective was to create a Community Outreach
Playbook to help sites engage minority organizations.
This playbook targets various stages in clinical trial
development where diversity can be better addressed.
Team tasks in creating this playbook included:
developing a database that identifies community
organizations that may be interested in engaging in
clinical trial education, interacting with clinical trial
site managers to understand their specific recruitment
needs, and implementing a social listening toolkit that
can continue as a sustainable effort to aid in increasing
health awareness targeted at under-represented
demographic subgroups. This project outlined a
strategy to help Pfizer ensure that future clinical trials
have participants that represent the epidemiology of
the disease being studied.