AFRICAN AMERICAN PARTICIPATION IN CLINICAL TRIALS

Perspective on African American Participation in Clinical Trials



Perspective on African American Participation in Clinical Trials

Introduction

There exists an unequal burden of cancer among minorities and the underserved, which is measured by a variety of indicators, such as incidence, mortality, and survival rates. The average annual incidence per 100,000 for all cancer sites during the period of 2005-2009 will be 445.3 for blacks, 401.4 for whites, 283.4 for Asian Americans and Americans of Pacific Islander descent, 270.0 for Hispanics, and 202.7 for Native Americans. The mortality rate for all cancers combined is approximately 33% higher in black Americans than in white Americans. Five-year survival rates, another measure of unequal burden, reveal that African Americans have the lowest rates, compared with all other ethnic groups.

It is well known that minority recruitment onto clinical trials faces a problem with rates of participation, ranging from 3% to 20%. The trials are most likely to be composed of white men and women with high educational backgrounds and socioeconomic status. However, it is also evident that there is a significant need, based on disease burden, for enrollment of various minority groups with diverse features related to socioeconomic status, age, and sex, onto clinical trials.

It is further evident that the number of minorities on clinical trials needs to increase to reduce the inherent selection bias and to address the objectivity of clinical trial design. There have been a host of barriers to clinical-trial enrollment reported among minority populations, particularly African Americans, including lack of physician participation, lack of subject participation, and recruitment costs [4,10-17]. Study design is a major barrier that raises critical issues regarding the restrictive inclusion and exclusion criteria [5-8,18,19]. It has been previously reported that cancer patients in minority populations have not benefited from clinical trials investigating quality of life, increased survival, and improved medical care and access.

Purpose of Study

The purpose of the present study is to systematically evaluate the influence of study design on the recruitment and enrollment of African Americans onto cancer treatment clinical trials at Howard University Cancer Center. In addition, we intend to determine the rate-limiting factors associated with enrolling African Americans onto treatment clinical trials at a historically black medical institution.

Literature Review

The inclusion and exclusion criteria, as well as a lack of available clinical trials opened at our institution, will be the primary barriers for African American participation at Howard University Cancer Center. Although African Americans' rates of participation in clinical trials in general are low, our review revealed that study design factors will be a significant cause of ineligibility. More specifically, there will be an overall eligibility rate of 8.3% in the current study, although 60.0% of the eligible patient population participated in our available treatment trials. This will enable us to better understand the ways to treat comorbidities among African American cancer patients. Although many of the inclusion and exclusion criteria, particularly related to comorbidity, are continual, it is unlikely that the mere opening of additional clinical trials alone will ...