Racial Disparities in Clinical Trials Statement of Need

African Americans and Clinical Trials

Research conducted over the past few decades has consistently shown a race, age and gender gap when it comes to access to cutting-edge clinical trials for patients diagnosed with cancer. Minority participation in clinical trials has traditionally been low, with reports ranging from 3% to 20%. For many years, racial and ethnic minority accrual to NCI-sponsored cancer treatment trials paralleled the incidence of new cancer
cases among those ethnic groups. However, in recent years, a new trend has emerged. Although the number of minority patients enrolled in clinical trials has remained relatively stable, the overall number of individuals admitted to trials has increased, therefore decreasing the minority percentage. For example, from 1998 to 2001, enrollment of black patients into clinical trials remained relatively stable (2309 versus
2347, respectively), however, a 22% increase in overall clinical trial accrual occurred from 23,343 in 1998 to >30,000 in 2001. According to research literature African Americans are interested primarily in being educated about research studies and lack of information was a primary reason they did not participate in clinical trials (Roberson, 1994). In addition, the literature stated that “African Americans requested broader
education about the importance of opportunities for participation in medical research" (Corby-Smith et al.1999).

Many health professionals and leaders in the African American community cite the Tuskegee Study, a 40- year study of the effects of syphilis on African-American men, as a factor contributing to low participation of African Americans in routine preventive care, clinical trials, and organ donation. Even though an effective treatment for syphilis was discovered in the 1950s, the study continued for another 20 years and the men involved were neither given treatment nor told of any treatment option. The impact of this abuse serves as a barrier that has engendered fear and mistrust of clinical research, especially among members of the African American population. Misuse of African Americans by the United States health care system existed long before Tuskegee, however, as documented by the use of African Americans as research
subjects for autopsies, dissections, and experiments during slavery for medical student training in southern medical schools. These historical occurrences are not forgotten in the African American community. In recent years, African Americans were reluctant to participate in clinical trials to test new AIDS treatments, citing a fear of a government conspiracy. Historical incidents, along with individual stories of mistrust and fear of research institutions, create an atmosphere of distrust among African Americans that still surrounds clinical research.

“It has long been known that illnesses like asthma, diabetes, hypertension, HIV/AIDS, and certain kinds of cancer affect African Americans more than other people. Yet little is known about the ways in which African Americans respond to treatment for these and other conditions. Despite government regulations that require minorities to be included in federally funded research projects, African Americans remain underrepresented in these important endeavors.”- Center for Information and Study on Clinical Research Participants (CISCRP) Participant Newsletter Feb.2008

Finding solutions to African Americans participating and staying in clinical trials should be multitasked. It can’t be done solely with “talking heads” with only academics, government agencies, stakeholders, medical professionals and statisticians in round table discussions, planning summits and attending symposiums, only to merely talk to each other about the problems.

Though some studies have shown that there is a “language barrier” to reaching African Americans, it ceases to be a language barrier when it comes to comprehension of purpose of clinical trials. Instead, it becomes a question of developing ground zero resources and increasing educational outreach programs that reach directly to the new participants targeted for inclusion.

The United States is the only country-- not Africa, Brazil, or the Caribbean-- where African Americans and Native Americans can be targeted for clinical trials. Grass root minorities are the key to new patient populations into clinical trials. Yet, there is a strong resistance by African Americans who fear being the guinea pig in what is seen as “big money’s experiments to get richer.” Unfortunately, most grass roots and underserved participants surveyed do not comprehend the usefulness of participation for the purpose of life saving drug development.

Finding solutions to the inclusion of African Americans in clinical recruitment requires grass roots outreach to educate this population about clinical trials. To understand racial disparities in clinical trials, the real discussion must be directed to the population of new participants to whom clinical trials are directed.

The challenge is to talk to the people to whom the clinical trials are directed. Moreover, it is to educate them about both the disease condition of the trial, as well as the clinical trial itself.

Clinical trials recruitment strategies to minorities utilize millions of dollars in advertising, internet and direct mail. However, advertising has only a 24-hour interest- to -response ratio; more than 70% of underserved African Americans do not have personal computers in their homes and direct mail is less effective for many reasons, especially during this time of recession, foreclosures and transitional lifestyles.

There is an urgent need for a broad scale field research study of African Americans as it relates to clinical trial recruitment and retention, and a need to develop community coalitions for ongoing clinical trials education to network for recruitment opportunities.

Though both government, medical and academic organizations are addressing the issue of racial disparities in clinical trials, there is yet another step to be taken. That step is what P&E Associates specializes in:

We talk directly to the people with disparities.
We find out what they need in order to participate and then bring them to the recruitment table.

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