Date of Conferral

2019

Degree

Doctor of Public Health (DrPH)

School

Public Health

Advisor

Donald Goodwin

Abstract

Globalization in clinical research and development has increased since the 1990s. Products approved in the United States (U.S.) and European Union (EU) include increasing numbers of research participants from low- and middle-income countries. The purposes of this quantitative correlational study were to investigate the lag time, or drug lag, between U.S. approval and the approval of selected drugs in all countries that hosted their pivotal clinical trials. The study population was limited to products approved first in the U.S. between 2006 and 2015. The health capability model and research for health justice framework were the theoretical frameworks for the study. Data were collected from public reports and websites of the U.S. Food and Drug Administration (FDA), European Medicines Agency, National Institutes of Health, local ministries of health, National Association of Securities Dealers Automated Quotations, New York Stock Exchange, the World Bank, and a subscription-based report from Springer Publications. Data were analyzed descriptively, with inferential statistics performed via Wilcoxon and chi-square tests. Independent variables were FDA approval year, drug indication, FDA review type, orphan indication, host country World Bank income category, sponsor market capitalization, and sponsor headquarters country. The dependent variable was drug lag, in months. The U.S. to EU drug lag was significantly shorter than U.S. to last host country drug lag. Lower host country income was also associated with longer drug lag. Reducing drug lag may create justice for research participants, improve health outcomes, and yield positive social changes.

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