Fewer Minorities Than Ever in U.S. Cancer Trials
By E.J. Mundell, HealthDay Reporter
TUESDAY, June 8 (HealthDayNews) -- Efforts over the past decade to make enrollment in cancer treatment trials more representative of the U.S. patient population have largely failed, a new report says.
Despite public concern and Congressional action, black and Hispanic patients make up an even smaller fraction of clinical trial participants today than they did in 1994, according to a study published in the June 9 issue of the Journal of the American Medical Association.
"We have to allow every American who has cancer to get equal access to clinical trials, regardless of their race or economic situation," said Dr. Harold P. Freeman, director of the National Cancer Institute's Center to Reduce Cancer Health Disparities in Bethesda, Md.
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. Public outcry on the issue led Congress to pass the 1994 National Institutes of Health Revitalization Act, which explicitly encouraged the increased participation of groups traditionally underrepresented in trials.
At the same time, the budget of the National Cancer Institute (NCI) -- the leading source for new trials -- doubled from $2 billion in 1993 to $4 billion in 2003, while the number of Americans enrolled in clinical trials swelled from 8,000 in 1996 to 12,000 in 2002.
To find out if any of these changes has affected what type of patients are enrolling in clinical trials, a group of Yale University researchers led by Dr. Vivek H. Murthy examined data on participants in NCI trials for breast, colorectal, lung and prostate cancers conducted between 2000 and 2002. They compared the demographics of participants enrolled in those trials to those of participants in similar NCI trials conducted between 1996 and 1998.
The Yale team reports things are getting worse, not better. In 1996, for example, black patients represented 11 percent of all cancer trial participants, but by 2002 that number had dropped to just 7.9 percent. Hispanics -- who make up 9.1 percent of the U.S. population -- made up just 3 percent of participants in clinical trials in 2002, down from 3.7 percent in 1996.
Women and the elderly remain underrepresented as well, although their percentages remained relatively unchanged from levels seen in the mid-1990s. In particular, the researchers noted the "strikingly low" representation of elderly patients in cancer trials. While the elderly make up about two-thirds of patients with either breast, colorectal, prostate or lung cancer, they represented only one-third of clinical trial participants, according to the report.
Commenting on the racial disparities outlined in the study, Freeman said he was "not surprised, because we've been aware of the problem for a while." In fact, the NCI created the Center to Reduce Cancer Health Disparities in 2001 to tackle just these types of issues, which Freeman believes are rooted in long-term social inequities.
Access to health care remains a key issue, he said, with large percentages of low-income blacks and Hispanics left unable to afford health insurance. "We've got a big problem right there," Freeman said, "dealing with populations that don't have access to even standard care."
Secondly, the past exploitation of black patients by white researchers -- most notably the 1932-1972 Tuskegee, Ala., trials in which physicians intentionally infected black men with the syphilis virus -- have left many blacks with a deep distrust of clinical trials in general. "That still resonates somewhat in the black community," Freeman said.
Numerous studies also suggest health-care professionals often treat minority patients differently than whites for a variety of reasons. "It's not always the case, but if you look across the country, something's going on there. Race does seem to matter," Freeman said. ""We need to work on creating better sensitivity between doctors and [minority] patients."
The Yale study does cite some success stories, however. In the late 1990s, concerns about the heightened death rate of black men with prostate cancer vs. whites led to greater scientific outreach to the black community. Now, enrollment for blacks in prostate cancer trials is "slightly greater than for whites," according to the Yale researchers -- reversing statistics from a decade ago.
Those results prove that community outreach can get results, Freeman said.
One outreach initiative currently under way at the center involves selecting knowledgeable individuals in the community to help minority patients "navigate through the clinical trials process," Freeman explained.
"It's important to help people get over the barriers they face getting into a clinical trial, and that's something we're testing right now," he said. "Our theory is that it might be helpful."
Read about efforts to make health care accessible to all Americans at the National Cancer Institute's Center to Reduce Cancer Health Disparities (crchd.nci.nih.gov ).
SOURCES: Harold P. Freeman, director, Center to Reduce Cancer Health Disparities, National Cancer Institute, Bethesda, Md.; June 9, 2004, Journal of the American Medical Association
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