For many years most clinical trials were done on white men only. African Americans, women, and other minorities were not included. It is reported that heart diseases cause more deaths than cancer and not just in white men! Participation in clinical trials is needed to improve diagnosis and treatment of heart disease in different ethnic groups and to understand why it affects different people in different ways. Clinical trials are particularly important for the development of precision medicine to meet the needs of all individuals.
Even today medical research critically needs more participation from minority groups. It requires equitable sampling, being inclusive of all members of the population regardless of educational attainment and encouragement wherever possible. Clinical trials must be ethically sound, with education and respect for the privacy rights of all participants.
As an African American woman with atherosclerotic disease (CAD/PAD), Chair of the University of Sarver Heart Minority Outreach Committee (CCHHE), living with all of the risk factors (diabetes, hypertension, and over 65, family history of heart disease) I truly realize how important it is to take care of my health, participate in trials and educate others in the Minority community to advocate for their health and the importance of their participation in these trials. The CCHHE, a team of over 30 women, at the University of Arizona gives me that platform.
However, it is well known that minority groups especially African Americans are hesitant and often excluded from participation in clinical trials programs. There are historical factors that explain their hesitation. One in particular we remember is the Tuskegee Study of 1932 in which African Americans were used without their consent for the study of untreated syphilis, and long before that the development and testing of vaccines using slaves in Jamaica in 1768. Nowhere is this more telling than in the history of Henrietta Lacks. In “The Immortal Life of Henrietta Lacks”, by Rebecca Skloot in 2011, the revelation that cellular material was taken from Henrietta’s body after her cervical cancer death is especially disparaging. No consent was ever requested or given for this insidious act. Yet, her blood cells were – and continue to be – used quite profitably by scientists around the world. And there are many other stories that fuel African Americans’ hesitation to take part in clinical trials. A lot of education is needed to dispel that mistrust.
CCHHE has taken some small steps to get this population to participate in a biorepository at the University of Arizona, Sarver Heart Center in Tucson, AZ. We made this request and the education about the program a part of all our outreach presentations. It required sensitivity and commitment to clarify the need, the process and to remove as much suspicion while adding a positive view of making a major step in healthcare trials for the future of medicine. This program and its start continue to be a successful part of the outreach program.
I try to lead by example and action. I personally am currently participating in the aforementioned biorepository for heart disease research. I created an endowment to fund research for women of color because I realize how critically important research is to this population. I actually began this work before I knew that I was a cardiovascular disese “victim” because the disease was so rampant in my family! I created the outreach team to raise awareness and fund the endowment and investigative research in heart disease for women of color. I am committed to the research and personally donate every year to the endowment, the investigative research fund and the outreach education program. I lead, teach, encourage, write grants, solicit individual donations, create an annual newsletter as a tool to educate and solicit support for the endowment, investigative research and participation in the actual research studies where needed for women in this population, especially women of color.
African American people continue to be skeptical about donating blood samples or participating in other clinical trials. But we are beginning to recognize that minority participation is desperately needed to find answers and cures because human trials from large and varied populations are the vital for research. Minorities are moving in the direction of for precision medicine for all. This is a giant step forward. The Global CVCT Forum must also play its role with active inclusion and education of the minority population for their increased participation in these trials.