NCI Office Focuses on Minority Accrual in Cancer Clinical Trials

BETHESDA, Md--Recruiting people from minority groups into clinical cancer trials calls for the biomedical community to be "compassionate, credible, and truthful" in how it portrays the value of those trials, Otis W. Brawley, MD, of the NCI’s Office of Special Populations Research, said at the American Society of Preventive Oncology annual meeting. "Physicians and medical institutions must have a good relationship with the people they serve," he said.

Dr. Brawley’s office looks not only at the needs of racial minority groups but also at those of the poor, the old, and the medically underserved. In addition, the office examines possible geographic differences in research or care.

Ensuring adequate representation of these groups in clinical trials, he said, may raise scientific, ethical, practical, political, and legal issues--often more than one at a time.

There is, for instance, the question of sample size. The law now requires statistical breakdowns by population subgroups. But while the minority proportion of the 30,000 people per year who take part in NCI treatment trials is roughly equal to their cancer incidence, Dr. Brawley said, simple proportionality may not provide enough power for adequate subset analysis.

Such analyses in studies of adjuvant therapy for colon cancer, for example, indicated that younger, female patients did better in the North Central Cancer Treatment Group (NCCTG) trials, while older, male subjects fared better in the Southwest Oncology Group (SWOG) study. Then, too, beta-blockers appear to work better for whites, while diuretics do a better job for blacks--"although there are plenty of exceptions," he said.

He noted that such "small differences in effect may be meaningless," since equal treatment generally produces equal outcomes regardless of race. He said, too, that there is no scientifically accepted definition of "race" in use by the NCI, and that the term is only a common sense social usage.

There are many barriers to poor or minority recruitment to prevention trials, Dr. Brawley said. A middle-class participant may have no trouble taking off from work and getting to the trial center, but poor people may find this an impossible burden due to lack of transport and loss of wages for missed work.

Some cultural groups may feel fatalistic about cancer and may not care what happens to them after a cancer diagnosis. They may find conflicting reports in the media confusing or be scared away by the wording of informed consent forms.

Lingering Suspicions

Worse yet is lingering suspicion of the Tuskegee experiment (in which black male prisoners with syphilis were deliberately not given treatment) and of 1993 legislation requiring minority inclusion in cancer trials. One potential subject told Dr. Brawley: "We always thought they wanted to experiment on us; now they’ve passed a law saying they have to."

The best way to recruit minorities is to explain everything. The recruiter’s race shouldn’t matter, he said. More important is that the recruiter or the institution is trusted. "We have to tell people what we know and what we don’t know," he said. Doctors have difficulty saying ‘I don’t know.’ They should just say, ‘I believe’ when they don’t have the answers.

Finally, Dr. Brawley said, "we must learn to accept ‘no’ as an answer when members of minority groups turn us down for participation in trials, even after our best explanations."