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Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

From the Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD

Address reprint requests to Lilia Talarico, MD, Division of Oncology Drug Products, HFD 150, Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20857; e-mail: Talarico{at}cder.fda.gov

PURPOSE: To analyze the age-related enrollment of cancer patients onto registration trials of new drugs or new indications approved by the US Food and Drug Administration from 1995 to 2002.

PATIENTS AND METHODS: This study involved retrospective analyses of demographic data of cancer patients enrolled onto registration trials. The data on 28,766 cancer patients from 55 registration trials were analyzed according to age distributions of 65, 70, and 75 years. The rates of enrollment in each age group for each cancer were compared with the corresponding rates in the US cancer population. The age distributions of the US cancer population were derived from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute for the period 1995 to 1999 based on the 2000 US Census.

RESULTS: The proportions of the overall patient populations aged 65, 70, and 75 years were 36%, 20%, and 9% compared with 60%, 46%, and 31%, respectively, in the US cancer population. Statistically significant under-representation of the elderly (P < .001) was noted in registration trials for all cancer treatment except for breast cancer hormonal therapies. Patients aged 70 years accounted for most of the under-representation.

CONCLUSION: Elderly were under-represented in the registration trials of new cancer therapies. Various strategies may be needed to evaluate cancer therapies for the elderly in prospective clinical trials and to improve cancer care in the elderly population.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL.

The views expressed are the result of independent work and do not represent the viewpoints or findings of the US Food and Drug Administration.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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