Clinical Research Trials: A Comparison of African Americans Who Have and Have Not Participated

Article excerpt

Abstract: The purpose of this is study was to gain an understanding of the knowledge and perceptions African Americans have that influence decisions to participate or not participate in clinical research trials. A survey instrument designed to measure the key variables; knowledge and perceptions of clinical research processes, and selected demographic characteristics were utilized in this study. The major finding suggests that African Americans who have been participants in a clinical trial are more likely to participate in future clinical trials if details are provided in advance concerning the requirements and criteria for their participation.

Key Words: Clinical Research Trials, African Americans

Recruiting an adequate number of volunteers for clinical research trials is crucial to the success of the trial. However, obtaining and retaining volunteers for participation in clinical research trials has been and remains an ongoing roblem for biomedical researchers (Trauth et al., 2000). Although the general public has come to expect and demand that the biomedical community develop new, safe and effective approaches to the prevention and treatment of diseases, that same general public is not aware of the important role that public participation plays in the development of medical advances. For example, it is estimated that no more than 2% of adult cancer patients who are potentially eligible to participate in a clinical research study (Tejeda et al., 1996).

Racial and ethnic minorities are under-represented in virtually all aspects of clinical research (El-Sadr & Capps, 1992; Fauci, 1989; Frierson & Wyche, 1994; Million-Underwood & Sanders, 1993; Thomas et al., 1994; Weiss & Kupfer, 1974). This is especially true for the African American minority group. Participation in clinical trials has the potential to identify effective prevention, and treatment strategies, especially for those chronic diseases such as cancer, diabetes, high blood pressure, and obesity that disproportionately affect African Americans (Singh et al., 1994). Since race can affect disease severity, progression, and response to drug therapy, under-representation of African Americans in clinical trials will decrease the ability to generalize study results to this population (Matthews, 1995). For these reasons, the National Institutes of Health (NIH) established guidelines for the inclusion of women and minorities and their sub-populations in its funded research with human subjects (Federal Register, 1994).

If future recruitment efforts of minority participants are to be successful, those responsible for both the funding and conduct of clinical research need to understand the perception minorities have regarding clinical research studies. In addition, researchers need to communicate the importance of participation in clinical research. Therefore, the primary purpose of this study was to gain an understanding of the knowledge and perceptions African Americans have that influence their decision to participate or not participate in a clinical research trial. The specific objective of the study was, to describe and compare African Americans who have and have not participated in clinical research trials on each of the following perceptual and demographic measures:

* Knowledge of clinical research processes,

* Perceptions of clinical research purposes and procedures, and

* Selected personal demographic characteristics: (a) gender, (b) age, (c) marital status, (d) education level, (e) employment status, (f) household income, and (g) the distance lived and worked from the Research Center.


For the purpose and objectives of this study the following terms were operationally defined:

* Clinical Trial: Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.

* Nonparticipant: African American adults in the Research Center's recruitment database who did not participate in a clinical trial. …