It is commonly known that our current clinical trials struggle to enroll adequate numbers of minority men. Our inability to enroll a cross section of men that truly reflects the general population in prostate cancer clinical trials means that our results might not accurately reflect the best information for a minority man.
The lack of minority participation in our trials hamstrings good clinical decisions for men of a minority group. Many researchers have been asking the question, why don’t minority men (especially men of African descent) participate. There are a few “theories,” but no good answers. It often is said that men of African descent are afraid of clinical trials because clinical trials are an attempt to commit racial genocide. The African American Community needs only to point to the horrendous abuses of the infamous “Tuskegee Syphilis Study “ as evidence of brutal abuse of African Americans (1)
Given our past mistakes and our prior terrible behavior we need to find ways to increase minority enrolment in clinical trials. We need to always remain aware of the concern about abuse. We also need to understand what other factor might play into the enrollment issue and, more importantly, begin to develop more effective recruiting methods which are responsive to these concerns.
In an attempt to begin some forward movement a group of researchers conducted a population-based study of men with early stage prostate cancer. They examined the relationships between race and ethnicity and 1) attitudes, 2) knowledge and 3) willingness to participate in clinical trials.
Through the California Cancer Registry they looked at data from November 2011 to November 2012. They identified all cases of prostate cancer in African American, Latino, and Asian American men ages 18-75 years, and a random sample of white men diagnosed in 2008 that were living within 60 miles of a site offering a clinical trial. Participants completed a 30-min telephone interview in English, Spanish, or Chinese. In this cross-sectional population-based study, they estimated associations between race and ethnicity and 1) attitudes, 2) knowledge and 3) willingness to participate in clinical trials.
Of the 855 participants, 52% were 65years or older, 42% were white, 24% Latino, 19% African American and 15% Asian American. The majority (81%) had medium-to-high health literacy. Compared to non-Latino white men, African American men were less likely to have above average knowledge of clinical trials, as were Asian American and Latino men. To the researcher’s surprise they found that there were no reported racial or ethnic differences in a man’s willingness to participate.
They did find there was a negative association with a man’s willingness to participate if they believed that it was the researchers who would be the main beneficiaries of the trial. However, if the men felt that it was patients who would be the main beneficiaries there was a positive association with a willingness to participate in a clinical trial.
The very important conclusion is that men with early stage prostate cancer are willing to take part in clinical trials if they believe that it will benefit patients. This willingness does not vary by race or ethnicity. The presentation of clinical trials must be made carefully with an emphasis on potential patient benefits.
(1) Why African Americans may not be participating in clinical trials; J Natl Med Assoc. 1996 Oct;88(10):630-4; http://www.ncbi.nlm.nih.gov/pubmed/8918067
Contemporary Clinical Trials. 2015 Oct 01 [Epub ahead of print]; Celia P Kaplan, Anna Maria Nápoles, Steven Narine, Steven Gregorich, Jennifer Livaudais-Toman, Tung Nguyen, Yan Leykin, Eric J Small