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Cancer Trials Versus the Real World in the United States

Al-Refaie, Waddah B. MD, FACS; Vickers, Selwyn M. MF, FACS; Zhong, Wei MPH; Parsons, Helen MPH; Rothenberger, David MD, FACS; Habermann, Elizabeth B. MPH, PhD

doi: 10.1097/SLA.0b013e31822a7047
Papers of the 131st ASA Annual Meeting

Background: Federal policies have been implemented to mitigate underenrollment in cancer trials in the United States. We sought to identify patterns and predictors of enrollment patterns to cancer trials in a contemporary era using a real world setting.

Study Design: The 2001–2008 California Cancer Registry was used to determine patterns and predictors of enrollment in clinical trials for stage 0 to IV solid organ malignant tumors. Multivariate techniques were used to identify predictors of enrollment in cancer protocols, controlling for covariates.

Results: Less than a percent (0.64%) of patients enrolled in clinical trials (1566 of 244,528). Black patients were less likely than whites to enroll in trials (0.48% vs 0.67%, P < 0.05). On multivariate analysis, older persons (>65 years), early stage cancer, and those with lung or gastrointestinal cancers were less likely to be enrolled in cancer trials. Results were consistent when evaluated among only nonbreast cancer protocols. Though approaching significance, black, underinsured, and uninsured patients showed trends toward underenrollment.

Conclusion: In addition to profoundly low overall cancer trial accrual, vast underrepresentation by age, cancer stage, and site continue to exist. The generalizability of these trials to a real world perspective remains an open question. Physicians, payers, the National Cancer Institute, and other stakeholders need to develop broader cancer trials to benefit the millions of patients with cancer in the United States.

This large population-based study from the California Cancer Registry shows profoundly low accrual rates to cancer protocols with vast underrepresentation by age, cancer stage and site.

From the Department of Surgery, University of Minnesota and Minneapolis Veteran Affairs Medical Center, Minneapolis, Minnesota.

Reprints: Waddah B. Al-Refaie, MD, FACS, Minnesota Surgical Outcomes Research Center, Department of Surgery, MMC no. 195, University of Minnesota and Minneapolis VAMC, 420 Delaware Street SE, Minneapolis, MN 55455. E-mail:

Supported by the Enhancing Minority Participation in Clinical Trials (EMPaCT) of the National Institute on Minority Health and Health Disparities and 2008 VFW Award.

To be presented at the 131st American Surgical Association Annual Meeting at Roca Baton, Florida in April 2011.

Disclosure: The authors declare that they have nothing to disclose.

© 2011 Lippincott Williams & Wilkins, Inc.