The Impact of the Pharmaceutical Industry on the improvement of Diversity and Inclusion in Clinical Trials

Authors

Beth Winkley, University of LynchburgFollow

Specialty

Oncology

Advisor

Trey Boyd

Abstract

ABSTRACT

Keywords: Diversity, Inclusion, Clinical trials, Pharmaceutical Industry

Purpose: The purpose of this article is to review the programs and strategies of the top five pharmaceutical companies created to improve diversity and inclusion (D&I) in clinical trials and assess if they align with the FDA’s recommendations and outlines.

Method: A PubMed literature search was conducted with search terms: clinical trials, top five pharma companies, diversity improvement, FDA guidance, and inclusion in clinical trials.

Results: A lack of evidence-based research to summarize the current strategies of the pharmaceutical companies and whether they align with the FDA guidance provided.

Conclusion: The FDA put forth guidelines for pharmaceutical companies which summarized the steps to enhance the eligibility criteria in clinical trials to improve diversity through inclusive trial practices, trial designs, and methodological approaches. The question remains whether the approach from the pharmaceutical companies is fulfilling these goals and if their strategies align with current research which has found successful strategies. The aim of this research is to evaluate the key strategies of the top five pharmaceutical companies and determine similarities, strengths, and whether these align with the FDA’s guidance.

Recommended Citation

Winkley B. The Impact of the Pharmaceutical Industry on the improvement of Diversity and Inclusion in Clinical Trials. University of Lynchburg DMSc Doctoral Project Assignment Repository. 2022; 4(3).