Barriers exist to patient participation in clinical trials

6015 Background: Multiple factors determine whether or not cancer pts enter a clinical trial. To find some of these causes, a seven physician MedOnc/Hem practice with access to CALGB, NSABP, ECOG, RTOG, GOG, industry and investigator initiated trials developed an internal survey. Methods: A one page data sheet was completed by physicians for a planned 1000 consecutive pts referred with a cancer diagnosis. Collected data includes diagnosis, stage, demographics, availability of clinical trials, enrollment status or reasons for non-enrollment. Results: From 4/04 thru 8/04 surveys were collected on 518 pts. 28 pts were determined not to have cancer. 490 pts with 493 cancers were reported. Diagnosis and % of total sample includes hospital tumor registry data base in brackets: Lung 24.9%15.4%,Breast 24.7%20.1%,Head M 44.7%46.8%,F 55.3%53.2%; median age 64 yrs; White 84.3%, Minority 15.7%; stage 0, I, II 46.1%, stage III, IV 53.9%. 22.2%(109/490) of cancer pts were considered eligible for clinical trial following initial presentation: 8.2%(40/490) enrolled. Of eligible pts, 36.7%(40/109) entered trial: M 60.5% vs F 34.0%(p=.018); <70 yrs 40.5% vs ≥ 70 yrs 24.0%(p=.16); White 37.0% vs Minority 35.3%; stage 0, I, II 6.6% vs stage III for those <70 it was 14.3%(12/84)(p=.022). Other reasons for not entering a trial include: no active trial 47.3%(232/490) and pt failing eligibility criteria 30.4%(149/490: poor functional status 14.9%, abnormal labs 3.5%, prior malignancy 1.4%, other 10.6%). Conclusion: An overall trial participation rate of 8.2% at intial presentation, while exceeding national averages, remains suboptimal. Lack of available trials, stringent entry criteria and pt choice are barriers to trial enrollment in this physician practice. Minority status is not a barrier but female gender may be. Advanced age appears to be a limiting factor for both pts and physicians. Further research to investigate clinical trial participation is warranted. No significant financial relationships to disclose.