Cancer Clinical Trials Report Few Details on Race and Ethnicity Differences; Review Conducted by the Dean of the Arizona College of Public Health

Cancer Clinical Trials Report Few Details on Race and Ethnicity Differences;
Review Conducted by the Dean of the Arizona College of Public Health

Sept. 25, 2002
From: Vicki B. Gaubeca, (520) 626-7301

A review of a decade's worth of cancer treatment and prevention trials revealed that very little information is gathered or reported related to participant race and ethnicity. Reviewers are recommending changes in the selection process to increase participation of minorities.

The results of this review were published in an article co-written by G. Marie Swanson, PhD, MPH, dean of the Mel and Enid Zuckerman Arizona College of Public Health, and John C. Bailar III, MD, PhD, professor emeritus at the College of Medicine, University of Chicago, in the September 1 issue of Cancer, a scientific journal published by the American Cancer Society.

Drs. Swanson and Bailar reviewed 261 randomized clinical cancer trials (205 focused on cancer treatment and 56 on cancer prevention) that were published in 11 scientific journals between 1990 and 2000. According to the review, more than 90 percent of the studies reported age and gender, but fewer than 30 percent reported race or ethnicity.

"Other studies have shown that the effectiveness of treatment and prevention efforts does vary by race and ethnicity," says Dr. Swanson, who has long been an advocate for the inclusion of women and minorities in clinical trials. "It is imperative that we find ways to encourage minorities to participate in clinical trials to ensure they receive the benefits of these studies."

The review supported the following observations:

Most cancer clinical trial reports fail to describe the race and ethnicity of participants.
When women and minorities are included in the clinical trials, it does not seem that their participation is by design; instead it seems to be happenstance.
When minorities and women are reported it is unclear whether this is done to support the trial's initial hypotheses or whether this is done to generate hypotheses.
When minorities and women are reported, differences in treatment or prevention outcomes often are found.
Recommendations made by trial reports rarely are made on the basis of a participant's gender or their race or ethnicity.
Clinical trials do not include participants diverse enough to ensure a broader applicability of results.

Dr. Swanson is concerned by the results of the review in light of the fact that minority inclusion has been a requirement of clinical trials as mandated by Congress through the National Institutes of Health (NIH) Revitalization Act of 1993.

"Limited attention to race and ethnicity as selection criteria for cancer treatment and prevention trials is puzzling," state Drs. Swanson and Bailar in the article. "given the generally poorer survival by stage [of the disease] of black patients for most malignacies, as well as the possibility that cultural and lifestyle differences across various ethnic groups may affect outcomes."

Among the recommendations made to increase the participation of minorities in clinical cancer trials was to enhance the 1996 Consolidated Standards of Reporting Trials (CONSORT) guidelines to include reporting of gender, race or ethnicity, and age for all clinical trials. Another recommendation was that investigators be more rigorous about how they select and recruit participants in their clinical trials and to be more aware of "the effects of social and economic status or cultural differences on accountability for and response to invitations to participate."

Drs. Swanson and Bailar conclude that "greater scientific rigor in participant selection and reporting and in subgroup analysis will strengthen clinical trials design and reduce selection bias." In turn, this will produce benefits that can be applied to a higher number of people.

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Established by the Arizona Board of Regents in January 2000, the Mel and Enid Zuckerman Arizona College of Public Health is the first public health college in the four corner states and represents a tri-university collaborative effort among the University of Arizona, Arizona State University and Northern Arizona University. The Arizona College of Public Health's mission is to promote the health of individuals and communities with a special emphasis on diverse populations and the Southwest. Programs concentrate on the reduction of health disparities, the development and maintenance of healthy communities, and the promotion of healthy lifestyles.

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