1. Background
Clinical trials are an essential means of improving outcomes of cancer
patients. Racial minorities and females have been underrepresented in
clinical trials through time. Historically, such disparities have been a
problem of multiracial societies such as US, but with globalization and
human migration, health disparities are becoming a global concern. In
February 2020 the European Parliament in its report on health
inequalities in the European Union identified addressing growing health
inequalities a priority [1]. The National Institute of Health (NIH)
of the United States was tasked to address these growing challenges
through the NIH Revitalization Act of 1993. An important mandate of the
NIH Revitalization Act was adequate reporting on minority and vulnerable
population in clinical trials. Despite these important efforts, various
studies over the ensuing two decades continue to report persistent
disparities in clinical trials [2-4].
As we enter the third decade of the 21st century, with
increasing awareness and advancements in communications and global
connectivity, an expectation would be that these disparities would be
resolving. We set out to evaluate the landscape of race and sex
reporting in phase III clinical trials in patients with lung cancer. We
selected lung cancer for our study because as the leading cause of
cancer death in the US, it has represented a significant proportion of
phase III cancer studies (14%) and is seen across the entire spectrum
of human races and sex [5-10].
The purpose of our study was to determine the historical trends and
current landscape of reporting and representation of females and
minorities in lung cancer phase III clinical trials. We chose to study
lung cancer phase III clinical trials because lung cancer is the most
common cause of cancer-related death and manifests differently depending
on one’s background, thus adequate reporting and representation are
essential [5-8]. Specifically, we looked at participation rates of
different races and sex over a 35-year time-period (1984-2019).