Amid Criticism, NCI Tries To Boost Minority Clinical-Trial Recruitment

Clinical-Trial Recruitment 'PLEASANT SUPRISE': NCI's Otis Brawley notes the racial makeup of treatment-trial patients was not planned. The National Cancer Institute (NCI), the largest of the National Institutes of Health, proudly touts its record of recruiting minorities into clinical trials it supports. "We have incredibly good representation of minorities on treatment trials," maintains Otis Brawley, senior investigator in the Community Oncology and Rehabilitation Branch of NCI's Division of Cancer Prevention and Control. NCI director Richard Klausner concurs, declaring that "for treatment trials, [minorities] are represented proportional to their percent for the disease." Yet many scientists who work with minority communities doubt the strength of NCI's commitment to ensuring the inclusion of minority subjects in institute-sponsored research. They contend that these groups not only should be included in trials in proportional numbers, but also should be full participatory partners in the research protocols. "Until we rely upon minority communities to instruct us how best to enroll and retain people of color in clinical trials, we will continue to fail in our [recruitment] attempts," explains Kevin Robert Frost, director of the Community Based Clinical Trials Program of the American Foundation for AIDS Research (AmFAR) in New York. "The answer is in these communities. . . . They should be integral to the process because anything doesn't make sense." Some of these issues were on the agenda at a meeting held in Washington, D.C., January 26 and 27, called the Conference on the Recruitment and Retention of Minority Participants in Clinical Cancer Research. It was cosponsored by NCI, the National Cancer Advisory Board (NCAB, NCI's major external advisory body), and NIH's offices of Research on Women's Health and Research on Minority Health as well as the Atlanta-based American Cancer Society and the Pittsburgh-based Oncology Nursing Society. The goal of the conference, according to NCAB chairwoman Barbara Rimer, a professor of community and family medicine at Duke University Medical Center, was to present case studies of successful and unsuccessful recruitment for clinical trials, to aid in teaching techniques for recruiting and retaining minority participants. Yet many of the attendees interviewed by The Scientist say the meeting only served to symbolize much of what is wrong with NCI's approach to recruitment of minority clinical-trial participants. TIME TO MOVE ON: M.D. Anderson's Lovell JObes wants to discuss solutions, not problems. "I'm at the point where I'm here for solutions, not talking about problems anymore," states conference session chairman Lovell Jones, director of experimental gynecology/ endocrinology at the M.D. Anderson Cancer Center in Houston. An NIH researcher, speaking on condition of anonymity, goes so far as to say that NCI is making no effort to alter the participation rates of minorities in clinical trials. The gathering had been in the planning stages for more than a year; according to participants, preparations gained crucial momentum last fall, after Klausner became NCI's director. Many give him credit for supporting the meeting and initiatives to provide funds for research into problems of minority retention and recruitment. Others, however, believe that he is not showing significant leadership in coping with these same challenges. It has been more than a year since strict federal guidelines on including minorities and women in clinical trials supported by NIH have taken effect. These guidelines were set forth in the NIH Revitalization Act of 1993, enacted by Congress and instituted beginning with grants funded for the 1995 fiscal year (M.E. Watanabe, The Scientist, March 6, 1995, page 14). The guidelines require all NIH-supported Phase III clinical studies to include as research subjects, wherever appropriate, women and minorities-major groups, like African Americans, as well as subgroups such as Haitians, Mexicans, and Vietnamese-in statistically relevant numbers. According to Brawley, there is a widespread assumption-including among members of Congress-that minorities are underrepresented in NCI-sponsored treatment trials conducted by extramural grantees. But, he notes, this appears not to be the case, as indicated by analysis of data that NIH has been collecting since the 1970s. For example, 8.5 percent of women with breast cancer are black, Brawley states, while 10 percent of the women on breast cancer treatment clinical trials are black. Brawley stresses, however, that this racial makeup of patients on treatment trials is not a result of conscious design. "It was a pleasant surprise," he acknowledges. He explains that no one knew the racial breakdown of NCI-supported trial participants, but by the mid-1990s enough data had been gathered for someone to analyze it. The analysis was conducted by Alberto Tejeda, a fellow in the Division of Cancer Prevention and Control. Tejeda found that the criticism of NCI for not having sufficient minorities on its treatment trials was not justified. But prevention trials are another story. Minorities are not signing up in representative numbers for NCI's three major cancer-prevention trials: the prostate cancer prevention trial; the breast cancer prevention trial; and the prostate, lung, colon, and ovarian cancer screening trials. According to Brawley, the prostate cancer prevention trial, for example, has recruited 16,000 men, only 8 percent of whom are minorities: 4 percent African American and 4 percent Hispanic. And these men, Brawley explains, are from the higher socioeconomic strata-more than 55 years of age, with college degrees and incomes greater than $50,000 per year. He adds that the 4 percent figures are probably overrepresentative of the numbers of men within the top socioeconomic classes among African Americans and Hispanics. SERIOUS ISSUES: Fox Chase Center president Robert Young says that "I don't think anybody knows, really, how" to recruit minorities to trials. Meeting participant Robert Young, president of the Fox Chase Cancer Center in Philadelphia, agrees that recruitment and retention of minorities are serious issues: "I don't think anybody knows, really, how to do this; everyone has struggled with how to increase the number of minority patients on clinical trials." Brawley, however, thinks that emphasis is being placed on the wrong issue. NCI, he proclaims, has "shown that there are really two classes of medical care in the U.S. for cancer, and blacks are less likely to get the same care as whites. "Everybody in Congress is obsessing on a few more people on clinical trials," Brawley remarks, while "thousands of blacks are getting substandard care." A major problem, as brought out in talk after talk at the conference, is that recruitment of minority clinical-trial subjects requires community outreach, which is expensive and not usually provided for in NCI grants for clinical research. Such endeavors, presenters stressed, necessitate the investment of large amounts of time to form a personal, trusting bond between the potentially wary clinical trial recruit and the medical service provider. Frequently this involves the need to use counselors fluent in the language the patients speak, ideally from within the specific minority communities. However, Rimer explains, NCI grants are for research costs only; the institute usually cannot pick up ancillary costs. These costs may include payments to counselors, phone-bank calls to locate subjects, advertisements in community publications, production and translation of educational materials, token payments to participants, and many other outreach expenses. "The NCI expects us to put more blacks on trials, but the funding for outreach is being reduced from an overall shrinking NIH pie," notes Oscar E. Streeter, Jr., a radiation oncologist at the University of Southern California's Kenneth Norris, Jr. Comprehensive Cancer Center and Hospital in Los Angeles. He points out that grantees fortunate enough to obtain funding from NCI still need to find additional sources of support for the outreach necessary to recruit trial subjects. Thus, cancer centers are left to their own devices to fund their compliance with the law. Streeter observes: "The NCI is saying, 'We don't care how you do it, just do it, whatever you have to do.'" In order to comply without using NCI money, he explains, "some cancer centers, such as M.D. Anderson, have funded their own program." As reported in the talks given at the conference, some trial recruitment has been done using money raised from churches. Other researchers ask health insurers to pick up some of the costs, and still others need to approach foundations or find money within their own operating funds. One way of bringing minority participants into clinical studies-paying or somehow giving financial rewards to patients-is highly controversial. While several researchers, in their presentations at the meeting, said they used such a recruitment technique, "that's kind of a dangerous track to take," Young says. He and others indicate that this method of attracting patients could lead to "coercion" of people to join clinical trials. Numerous presenters at the conference pointed to a major problem with current methods of signing up clinical-trial participants: The poorest of the poor of all races are not being reached. Speakers from a variety of communities referred to the effects of "crushing poverty"-the basic struggle to survive-and its concomitant physical and emotional ills, as preventing the very poor from considering or being considered for inclusion in clinical research trials. For example, Jon Kerner, associate director for prevention and control at Georgetown University Medical Center's Lombardi Cancer Center, explained that the poorest groups of cancer patients include blacks both under and over 65 years of age, and whites less than 65 who had no insurance or only government insurance. People in these groups, he said, are more likely than those individuals of a higher socioeconomic status to have comorbidities-other diseases such as hypertension and diabetes-along with cancer. Brawley concurs. He reported at the meeting that although significant numbers of minority candidates were screened for inclusion in NCI's cancer-prevention trials, the major reason for exclusion from the trials was comorbidity. Furthermore, he tells The Scientist, "the forgotten minority" in the prostate cancer prevention trial is poor whites, who are not being recruited in representative numbers, along with poor blacks and Hispanics. 'MINORITY' WHITES: Gilbert Friedell says that poor, rural white populatins share many problems with racial and ethnic minoritie. Cancer researcher Gilbert H. Friedell of the National Appalachian Leadership Initiative on Cancer, whose group was not invited to the minority recruitment and retention meeting, agrees that poor whites are an excluded minority. "People who are poor, white, low-income-particularly rural white populations, which often [have low literacy rates]-have many of the same obstacles to achievement as do poor, underserved, relatively poorly educated minorities; that is, categorized on the basis of race or ethnicity," contends Friedell, director of cancer prevention for the University of Kentucky Cancer Program, Markey Cancer Center, in Lexington. BASIC QUESTIONS: Harlem Hospital's Harold Freeman says NCI needs to examine whether the right researchers and right people are using the studies. NCAB member Harold Freeman, chairman of the President's Cancer Panel-which monitors and guides the National Cancer Program and advises the president on matters pertaining to cancer-stated at the meeting that the culture of poverty may have an influence on development of prostate cancer. He cautioned the researchers: "You haven't answered the fundamental question about poverty itself." He continued that studies are needed to disentangle race, economics, and culture. "Are we asking the right researchers to do the research?" asked Freeman, who is also head of surgery at New York City's Harlem Hospital. "Are we involving the right institutions?" While conference participants had been looking forward to the meeting for a year, some of the attendees were disappointed-and others were outright angry-because they expected a dynamic that did not occur. Scientists who were displeased with the gathering state that they expected the involvement of community activists, as well as the NCI-sponsored oncology groups, multicenter study groups that coordinate large clinical trials and have had difficulty recruiting and retaining minorities. But most of these individuals were not present at the conference. Without such involvement, it is difficult to conclude how best to proceed with recruitment and retention, critics of the meeting contend. M.D. Anderson's Jones, a cofounder of the Intercultural Cancer Council (ICC), a broad-based group representing community and major cancer advocacy organizations, acknowledges that some good solutions to problems of minority recruitment were presented. However, he complains, they were presented to the wrong people-those heavily involved in the recruiting process. "They [the presenters] were like preaching to the choir," he declares. "This was supposed to be an exchange of information, a discussion of ideas," maintains Klausner. "These meetings are not an issue of preaching. This was not a political rally. This was a very valuable scientific meeting, a discussion of these issues among the individuals interested and involved in clinical research and clinical trials of the NCI." "I think it's really easy to come up with simplistic criticisms," Rimer asserts. "The purpose of the conference was not to educate the cooperative groups or any one specific group." Yet Jones points out that, in his opinion, a number of important agencies and organizations seemed to have been left off the mailing list, including the Centers for Disease Control and Prevention, which supports tumor registries, often used by researchers to locate cancer patients and their families for clinical trials. Other notable absences, he comments, were many of the oncology groups. Jones was also disappointed that the meeting did not attract directors of the cancer centers that are NCI's grantees, other than Fox Chase's Young, an invited speaker who discussed the effect of health-maintenance organizations on clinical-trial participation. But Young does not see the absence of high-level policy-makers from other cancer centers as a negative factor. Part of the reason for their absence, he speculates, is that "I don't think people yet have a view of what mechanisms they could put in place to solve this problem." Young believes that rather than attend the conference, they are waiting for the meeting report, which is due to come out in May. The report is expected to contain "recommendations on overcoming the barriers to recruitment," according to NCAB member Zora Kramer Brown, founder and chairwoman of the Breast Cancer Resource Committee, an education and advocacy group in Washington, D.C. CULTURAL OBSTACLES: NCAB member Zora Kramer Brown believes that NCI staff lack "access" to minority communities, causing recruitment problems. Some attendees believe that a major problem with the gathering was that NCI hosted what Klausner called "a scientific meeting"-with presentations and abundant tables and charts-when what was needed was a workshop, addressing solutions to problems for those still stymied on how to recruit and maintain minorities. Several participants refer to the presentations as "talking heads." One NIH researcher who attended the conference, speaking on condition of anonymity, disgustedly states, "This did feel like the old NCI doing business the way they used to do." Yet several activists in the minority community acknowledge that it was NCI's new leadership that made such a meeting possible. "It became more of a viable thing happening with Klausner coming in," Jones comments. According to Jones, the meeting had been discussed during the tenure of Klausner's predecessor, Samuel Broder, who left his position last summer, but never received the support of Broder's administration. Klausner rapidly agreed to support the conference when it was discussed at the NCAB's September meeting, according to Brown. Brown sees this as a commitment from NCI to minority recruitment and retention goals. "The fact that we were able to make a decision in September and host a conference in January certainly speaks volumes as to where the NCI's heart is," Brown states. Although no one interviewed by The Scientist says that Klausner is part of the problem, some expect the NCI director to show more sensitivity to minority issues than did his predecessors. ICC members, for example, say they had a very positive meeting with Klausner last fall, in which he expressed his concern for and sensitivity to the minority community's needs. UNDER SCRUTINY: NCI director Richard Klausner is expected to show more sensitivity to minority communities than his predecessors. But Jones publicly criticized Klausner for leaving the minorities conference, with no explanation, after making welcoming remarks. Although some attendees note that the director's early departure was understandable in light of the government furloughs that immediately preceded the meeting, Jones and several others felt his leaving without an excuse was a slight. "One has to consider that there is a great deal of negative history between NCI and these [minority] communities," Jones states. "Actions that might seem harmless can be the most detrimental." "Unfortunately, since becoming director of such a large institute, I find myself frequently being asked to give remarks at conferences and meetings that I would love to be able to spend much more time at," Klausner tells The Scientist. "But the demands on my time are really great, and I had to leave that meeting to attend a series of other meetings in these very long, 15-hour workdays." He adds: "That meeting was of particular interest to me," and notes that NCI was well represented by staff at all levels, who reported back to him on the sessions. Jones is now in close communication with Klausner over substantive issues affecting NCI's minority research initiatives. Jones and others believe that Klausner "is in a learning mode." Even those who were satisfied with the meeting are not entirely pleased with NCI's handling of clinical trials. Brown, for example, is concerned that NCI itself does not have the ability to recruit African-American women for any breast cancer trial because the intramural staff do not have "access" to the community. She says, "It's not so much about the politics of clinical trials, but the culture of the community. We must get away from the notion that it's never been done before and figure out how it can be done." Rimer, too, acknowledges that "Yes, NCI isn't doing enough in the broad sense because many of the problems are social problems, insurance problems, and so forth, but I think NCI has taken some important steps in recent months. We do, however, need to keep in mind the most important goal-raising the participation of all Americans in approved clinical trials." However, Rimer stresses, recently NCI has made a commitment to finding methods to recruit and retain minorities in clinical trials. These steps, she says, include the conference, a series of new grants announced there-two for improving recruitment of women and minorities and a third to encourage young physicians from minority groups to train in clinical oncology and research-and a commitment to fund seven regional conferences on the same topic through a request for applications. Jones fully supports these new grant programs, but he is skeptical about their chances for success. He is concerned that few ongoing trials are run by researchers who themselves are minorities. Reports from the meeting showed that the most successful of the clinical trials in minority communities had significant involvement of medical personnel from these communities. States Jones: "It is nice that we have moved from the back of the bus, but I would like to have the opportunity to drive it now." Myrna E. Watanabe is a science writer based in Yonkers, N.Y.

Amid Criticism, NCI Tries To Boost Minority Clinical-Trial Recruitment

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