Abstract B11: Socioeconomic analysis of patients referred for Phase I clinical trials at a dedicated Phase I clinic in a comprehensive cancer center

Introduction: Cancer is a leading cause of death in United States. Once standard effective therapies are exhausted, or in the absence of approved successful therapeutic options, patients with terminal cancer are offered best supportive care or enrollment on early clinical trials. The enrollment on clinical trials has been demonstrated to be affected by racial and socioeconomic variables . Little is known about how such variables affect the pattern of referral of patients to Phase I clinical trials.

Methods: During the fiscal year 2005, the first year of operation of the Phase I Clinic at M.D. Anderson Cancer Center (MDACC), we analyzed variables of referred patient's such as age, sex, marital status, race, religion, and health insurance status, and geographic home location. We compared these variables with those of the whole patient population at the MDACC. This study was approved by the IRB. We hypothesized that there were no significant demographic difference between the patients referred to the Phase I Clinic and the overall MDACC population. Statistical analyses were performed using SAS statistical software and Chi square statistical test was two-sided and the level of statistical significance is 0.05.

Results: During the study period, 363 patients were referred to the Phase I Clinic, while about 65,000 patients were served at MDACC. We found that there was no statistically significant differences between patients referred to the clinic and the overall MDACC patient population based on sex, age, or home geography (p> 0.05) (Table). For race, African Americans represented 8.3% of the patients referred for Phase I trials vs 7.0% of the overall MDACC population (p = 0.37). For religion, the only significant difference was in the proportion of people who did not specify their religion (30.3% vs 14.3%; Phase I Clinic vs overall MDACC) (P<0.05). Patients were less likely to be referred to the Phase I Clinic if they were self-pay (3.57% vs. 8.71%) or covered by PPO (26.33% vs. 17.08%) (p = 0.021). Patients that identified themselves as married were more likely to be referred (81.3% vs 66%) (p<0.05).

Conclusions: The preliminary data suggest that patients who are married are more likely to be referred than those that are single. and self-pay patients are less likely to be referred to our Phase I Clinic. Sex, age, and race are well represented in our Phase I Clinic population, and these variables do not appear to be a barrier to referral for early clinical trials at M.D. Anderson Cancer Center.