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).