Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee.

Background: Disparities in cancer outcome among different subsets of the American population related to ethnic background have been well documented. Clinical trials represent the most powerful strategy for improving cancer treatments, but racial and ethnic minority patients are frequently underrepresented among patients accrued to these protocols. Proof of comparable efficacy for a promising cancer therapy in different groups of patients requires diversity in the clinical trial populations so that study results will be generalizable. Appropriate targets for accrual of minority ethnicity patients have not previously been defined.

Methods: The National Cancer Database (NCDB) is maintained jointly by the American Cancer Society and the American College of Surgeons. Information submitted by tumor registries throughout the United States represents an estimated 70% of newly diagnosed cancer cases. The authors analyzed NCDB reports on ethnic distribution of patients with breast, prostate, nonsmall cell lung, and colorectal cancer, stratified by stage of disease at diagnosis.

Results: African Americans with cancer of the breast and prostate had the most notable patterns of disproportionate representation among populations with advanced-stage disease. The authors compiled a table of suggested accrual targets for selected solid-organ cancers based on NCDB stage-specific reports.

Conclusions: Clinical trial results will be more meaningful if participating patients reflect the site- and stage-specific populations that are under study. The authors recommended that clinical trial investigators incorporate accrual targets for minority ethnicity populations into the study design.