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COMMENTARY
Disparities in Participation in Cancer Clinical Trials in the United States A Symptom of a Healthcare System in Crisis Gerardo Colon-Otero, MD1 Robert C. Smallridge, MD2 Lawrence A. Solberg Jr, PhD, MD1 Thomas D. Keith, PharmD3 Timothy A. Woodward, MD4 Floyd B. Willis, MD5 Ajani N. Dunn, MHA3 1 Division of Hematology/Oncology, Mayo Clinic, Health Disparities Program, Mayo Clinic Cancer Center, Jacksonville, Florida. 2 Division of Endocrinology, Mayo Clinic, Health Disparities Program, Mayo Clinic Cancer Center, Jacksonville, Florida. 3 Department of Administration, Mayo Clinic, Health Disparities Program, Mayo Clinic Cancer Center, Jacksonville, Florida. 4 Division of Gastroenterology and Hepatology, Mayo Clinic, Health Disparities Program, Mayo Clinic Cancer Center, Jacksonville, Florida. 5 Department of Family Medicine, Mayo Clinic, Health Disparities Program, Mayo Clinic Cancer Center, Jacksonville, Florida.
D
Editing, proofreading, and reference verification were provided by the Section of Scientific Publications, Mayo Clinic. Address for reprints: Gerardo Colon-Otero, MD, Division of Hematology/Oncology, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224; E-mail:
[email protected] Received June 29, 2007; revision received August 13, 2007; accepted August 21, 2007.
ª 2007 American Cancer Society
isparities in minorities’ representation in cancer clinical trials have been shown only in adult populations, which suggest that the main causes of these disparities relate to health system-based barriers, including issues of poverty (lack of insurance), poor access to trials, and an inadequate number of clinical trials. Initiatives that increase the participation of community physicians in cancer clinical research trials and increase low socioeconomic status patients’ access to cancer trials will likely ameliorate this problem. Multiple studies have confirmed the under-representation of minorities in cancer clinical trials.1–3 Also under-represented in these clinical trials are older individuals, individuals of low socioeconomic status, and those residing in rural communities.4,5 Such disparities have profound effects on our society by not allowing segments of the population to benefit from cancer research advances, by creating uncertainties concerning the applicability of research findings to the population at large, and by directly affecting clinical research outcomes, given the prognostic implications of healthcare disparities. The National Cancer Institute (NCI) of the National Institutes of Health has had limited success with multiple initiatives directed at eliminating these disparities. In this commentary, we
DOI 10.1002/cncr.23201 Published online 17 December 2007 in Wiley InterScience (www.interscience.wiley.com).
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CANCER
February 1, 2008 / Volume 112 / Number 3
TABLE 1 Uninsured and Race* Race/Ethnicity
US Population
Uninsured
White Hispanic Black Asian American Indian
69.1% 12.5% 12.3% 3.3% 0.9%
50.2% 25.8% 17.1% 5.0% 1.8%
* US Census Bureau. Data adapted from DeNavas-Walt.8
discuss the main causes of these disparities and their potential solutions.
Main Causes of Disparities in Adult Patients Participation in cancer clinical trials The multiple reasons for under-representation of minorities in cancer clinical trials at the individual patient level include distrust of clinical trials and healthcare providers, ignorance about clinical trials, lack of transportation, poor or no health insurance, inflexible job schedules, insufficient outreach efforts, and lack of patient advocates. Analysis of data from patients entered in NCI Cooperative Groups trials for 1998–1999 demonstrates that there are no differences in minority representation up to the age of 29 years. Actually, 50% of all children with cancer are treated as part of cancer clinical trials compared with
