Still Too Few Minority Participants in U.S. Clinical Trials, Study Finds
FRIDAY, March 21, 2014 -- It's been 20 years since Congress required that research funded by the U.S. National Institutes of Health (NIH) include minorities, but non-whites still account for less than 5 percent of clinical trial participants, according to a new report.
The study from University of California, Davis, Comprehensive Cancer Center also revealed that less than 2 percent of clinical cancer studies focus on people of non-white races or ethnic groups.
The findings, published online March 18 in Cancer, revealed that although black people have the highest rates of cancer, Hispanics and blacks have a participation rate of just 1.3 percent in cancer clinical trials.
"The proportion of minorities in clinical research remains very low and is not representative of the U.S. population with cancer. What is needed is deliberate effort. Minorities are not hard to reach. They are hardly reached," study leader Moon Chen, the cancer center's associate director for cancer control, said in a UC Davis news release.
"Whatever happens in the laboratory or in the clinic needs to be applied to solving real-world problems, and those relate to the disproportionate effects of cancer and other diseases on racial and ethnic minorities," Chen added.
In conducting the study, the researchers reviewed all registered clinical trials sponsored by the NIH in January 2013 to find out how often information on minorities was reported or examined.
The researchers counted a total of about 10,000 clinical trials funded by the NIH. Of these studies, only about 150 focused on a particular ethnic or minority population. This amounts to less than 2 percent of all clinical trials, the authors pointed out.
Summaries on research published between January and March 2013 were also analyzed to determine how often minority participation in clinical trials was specifically discussed. Of the 42 studies the team identified, only five had reports that specifically examined participation levels by race and ethnicity.
Previous studies focused on minorities, however, have provided valuable insight into treatment for certain types of cancer, the researchers explained. Ethnic and geographic differences could affect how cancer progresses as well as how patients respond to various treatments.
"In lung cancer, it opened our eyes," said the study's co-author, Karen Kelly, associate director for clinical research at the UC Davis cancer center. "Clinical trials in diverse populations can help us understand the biology of disease, and why a drug may produce a higher response rate and higher toxicity in one group than in another," Kelly said in the news release.
The study authors cautioned that cancer is a growing burden in states with diverse populations, such as in California, Hawaii, New Mexico and Texas. They also noted that clinical trials are essential to the development of new cancer drugs and treatments. Participation in these studies, the researchers added, can improve survival rates for people with certain types of tumors.
Cost, transportation issues and cultural differences could prevent minorities from participating in clinical trials, the study authors suggested. However, the investigators found that minority children are well represented in cancer-related clinical trials, with 60 percent of patients younger than age 15 enrolled, which is equal to or greater than their proportion of the population.
"The record of participation by racial/ethnic populations in pediatric clinical trials suggests that a comparable record is potentially achievable in clinical trials for adults," Chen's team wrote in the report.
"The solution is not changing the attitudes of minorities but rather in ensuring access to health research. Clinical trials should be designed to include and focus on specific populations, and scientific journals should insist on appropriate representation and analyses of NIH-funded research by race and ethnicity," the authors concluded.
The U.S. Department of Health and Human Services has more on the role of minorities in clinical trials.
Posted: March 2014