**Scientific and Ethical Considerations for Increasing Minority Participation in Clinical Trials Minority Participation in Clinical Trials**

**Scientific and Ethical Considerations for Increasing** 

DOI: 10.5772/intechopen.70181

Julius M. Wilder Julius M. Wilder Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.70181

#### **Abstract**

Since its inception, a major weakness in clinical trial research has been an inability to recruit diverse populations into clinical trials. These under-represented populations are mostly comprised of the poor, the elderly, children, women, and racial/ethnic minorities (African Americans and Hispanics). This fundamental weakness is further exacerbated by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. There are various patient specific, provider specific, and policy related causes for the existence of these disparities. Regardless of the cause, the lack of participation of these groups in clinical trials raises important questions about the quality and ethics of clinical research. The goal of this document is to discuss the evidence and reasons behind disparities in clinical trial participation. We also provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of financial incentives, the impact of a more stringent policy and review process for product approval from the Food and Drug Administration (FDA) including a diversity mandate with an associated population black box warning.

**Keywords:** African American, hispanic, clinical trials, underrepresented, health disparities, food and drug administration (FDA)

#### **1. Introduction**

Since its inception, a major weakness in clinical trial research has been an inability to recruit diverse populations into clinical trials. These under-represented populations are mostly comprised of the poor, the elderly, children, women, and racial/ethnic minorities (African Americans and Hispanics). This fundamental weakness is further exacerbated by the fact that these same groups are often disproportionately affected by the diseases being studied in clinical trials. There are various patient specific, provider specific, and policy related causes for the existence

Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons

of these disparities. Regardless of the cause, the lack of participation of these groups in clinical trials raises important questions about the quality and ethics of clinical research. The goal of this document is to discuss the evidence and reasons behind disparities in clinical trial participation. We also provide a discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of financial incentives, the impact of a more stringent policy and review process for product approval from the Food and Drug Administration (FDA) including a diversity mandate with an associated population black box warning.

over time in North America and Europe. Our main outcome was the rate of African American/ black participation in North American HCV clinical trials [10]. There was a statistically significant difference among the expected and observed participation of African Americans in HCV clinical trials in North America based on the prevalence of this disease within the population. The observed rate was 0.148 (95% CI, 0.126–0.174). Therefore, among those clinical trials reporting race, African Americans were significantly under-represented, especially given the

Scientific and Ethical Considerations for Increasing Minority Participation in Clinical Trials

http://dx.doi.org/10.5772/intechopen.70181

5

The persistent disparity in minority clinical trial participation is a result of a combination of historical, demographic, and socioeconomic factors. These complex issues combine to create barriers preventing clinical researchers from reaching communities and barriers preventing

Socioeconomic status (SES) is a major contributor to disparities in minority clinical trial participation. The mechanism through which SES impacts minority trial accrual is *primarily* through individual patient level access to resources associated with clinical trial participation. Lower levels of education and income are known to correlate with a lack of insurance and underinsurance. Previous estimates have shown that up to 30% of the US population is underinsured or uninsured [11]. While the "Patient Protection and Affordable Care Act, 2010" will significantly improve access to health insurance, the impact on clinical trial participation will need to be studied given the lack of uniformity in implementation across the individual states in the US. Low SES presents issues with transportation as well [12]. Hence, patients with limited transportation resources are more likely not to be able to logistically make the follow up appointments associated with participation in a clinical trial [1, 12]. The cost of transportation and clinical trial research participation goes beyond typical costs such as fuel and mileage. Many patients of lower SES cannot afford to miss the time from work required for clinical trial visits as well. A lack of education and awareness of cancer and clinical trials has been shown to contribute to reduced participation in clinical trials [12–15] due to a lack of knowledge concerning the cancer diagnosis, treatment options, and precisely what is clinical research. One's SES is often reflected in the neighborhood that they live. Unfortunately, living in lower SES neighborhoods (be they urban or rural) reduces the likelihood of one having

Cultural issues related to race and ethnicity also contribute to disparities in clinical trial participation. The race of one's provider can impact access to clinical trials. Under-represented minorities are more likely to receive healthcare from a physician who is also a minority [1, 16]. Few minority physicians are engaged in clinical research and this thus reduces opportunities for the minority populations they serve to be engaged in clinical research. A lack of culturally appropriate educational materials targeting individuals with diverse cultural backgrounds and in whom English is their second language contributes to an inability to recruit individu-

disproportionate burden of hepatitis C within this population [9].

communities from engaging in clinical trial research.

**3. Reasons for the disparity**

access to clinical trial research [12].

als of Hispanic and other ethnic backgrounds [12, 17–19].
