Enrolling Minorities in Cancer Clinical Trials
A study finds that participation in clinical trials by African-Americans and Hispanics has declined over the last two decades.
Clinical trials are a crucial step in the path toward approval of new anticancer therapeutics and should strive to enroll a diverse group of participants, experts say. The inclusion of patients from different racial and ethnic groups can help researchers determine whether the results of the clinical trial can be generalized to the broader public.
A study presented at the 10th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held in Atlanta Sept. 25-28, 2017, indicates that ethnic minorities are generally underrepresented in clinical trials.
And even worse, African-American and Hispanic enrollment in cancer clinical trials declined over the past two decades, said the study’s lead author, Narjust Duma, MD, a hematology/oncology fellow at the Mayo Clinic in Rochester, Minnesota.
One potential explanation for the drop could be the increasing use of genetic information in cancer trials, Duma said. In recent years, many trials have sought to study drugs that treat cancer by targeting certain genetic mutations. To identify the patients who are most likely to respond to the drugs, many clinical trials now require molecular testing of tumors, Duma explained.
"This is leading to significant advances; however, it is vastly more expensive to run these trials, often leaving a limited budget to recruit patients or do outreach to minorities," Duma said. Cultural biases and language barriers may also make minorities less likely to enroll in clinical trials, Duma added.
In order to study minority participation in clinical trials, Duma and colleagues analyzed enrollment data from all cancer therapeutic trials reported as completed in clinicaltrials.gov, a database of publicly and privately supported clinical trials, from 2003 to 2016. From a pool of 55,689 enrollees, the study showed that 83 percent were white, 6 percent were African-American, 5.3 percent were Asian, 2.6 percent were Hispanic, and 2.4 percent were classified as "other."
African-American and Hispanic representation declined when compared with historical data from 1996 to 2002. In the 1996-2002 period, Duma said, African-Americans represented 9.2 percent of the patients in clinical trials and Hispanics represented 3.1 percent.
Duma identified several potential ways to narrow the gap of participation in clinical trials:
- Increase clinical trial partnerships between major cancer centers and satellite hospitals. Duma suggested that patients could be enrolled at their local hospital, and undergo treatment there, while data could be sent to the partnering cancer center.
- Targeted interventions, such as Spanish interpreters, could be used to help enroll minority patients in clinical trials.
- Health care providers should be mindful of the need to enroll more patients from underrepresented populations, and should be willing to discuss risks and benefits with patients.
Duma said the main limitation of the study is that race and ethnicity are generally self-reported, which could lead to some inconsistencies in data.