Cary P Gross1, Natalie Wong, Joel A Dubin, Susan T Mayne, Harlan M Krumholz. 1. Section of General Internal Medicine, Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine, Primary Care Center, New Haven, Connecticut 06520, USA. cary.gross@yale.edu
Abstract
BACKGROUND: The Medicare program was revised in 2000 to authorize payment of routine care costs for patients in clinical trials. This study evaluates the impact of the Medicare reimbursement policy change on enrollment of older patients into cancer trials. METHODS: We conducted a longitudinal analysis of the enrollment of older patients in National Cancer Institute-sponsored lung, colorectal, breast, and prostate cancer trials from January 1996 through June 2003. Our primary analysis was restricted to 23 trials that were actively accruing before and after the Medicare change, enrolled more than 100 patients, and had at least 5% of participants older than 65 years. We used multivariate logistic regression to determine whether the proportion of participants who were elderly increased after the policy change. RESULTS: The primary study sample consisted of 16,135 patients in 23 trials. After adjusting for cancer type, trial exclusion criteria, and patient sociodemographic characteristics in multivariate analysis, no significant change occurred in the representation of older patients after the policy change (adjusted odds of participants being elderly after vs before policy change, 1.13; 95% confidence interval, 0.96-1.32; P = .14). In a secondary analysis of patients who had enrolled in any trial during the study period, no significant change occurred in enrollment of older persons after the policy change among phase 3 or phase 1 and 2 trial participants (P = .84 and P = .07 in adjusted analyses, respectively). CONCLUSION: The Medicare trial reimbursement policy was not associated with a significant increase in the enrollment of older patients in cancer trials.
BACKGROUND: The Medicare program was revised in 2000 to authorize payment of routine care costs for patients in clinical trials. This study evaluates the impact of the Medicare reimbursement policy change on enrollment of older patients into cancer trials. METHODS: We conducted a longitudinal analysis of the enrollment of older patients in National Cancer Institute-sponsored lung, colorectal, breast, and prostate cancer trials from January 1996 through June 2003. Our primary analysis was restricted to 23 trials that were actively accruing before and after the Medicare change, enrolled more than 100 patients, and had at least 5% of participants older than 65 years. We used multivariate logistic regression to determine whether the proportion of participants who were elderly increased after the policy change. RESULTS: The primary study sample consisted of 16,135 patients in 23 trials. After adjusting for cancer type, trial exclusion criteria, and patient sociodemographic characteristics in multivariate analysis, no significant change occurred in the representation of older patients after the policy change (adjusted odds of participants being elderly after vs before policy change, 1.13; 95% confidence interval, 0.96-1.32; P = .14). In a secondary analysis of patients who had enrolled in any trial during the study period, no significant change occurred in enrollment of older persons after the policy change among phase 3 or phase 1 and 2 trial participants (P = .84 and P = .07 in adjusted analyses, respectively). CONCLUSION: The Medicare trial reimbursement policy was not associated with a significant increase in the enrollment of older patients in cancer trials.
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