Why is it so difficult to enroll patients in clinical trials

6552 Background: Nationwide, approximately 3% of patients participate in therapeutic clinical trials. It is presumed that patient education and navigation will increase enrollment. For these interventions to work, a clear understanding of the reasons patients do not enroll is needed. Employing our enrollment framework (Kanarek et al, 2012), we set out to define, at one comprehensive cancer center, the reasons new cancer patients fail to enroll onto clinical trials. Methods: Medical Oncology records from a consecutive series of new breast, non-small cell lung (NSCLC), pancreas and prostate cancer patients were abstracted. Abstraction was based on seven framework sequential steps: 1) trial availability, 2) trial eligibility, 3) physician triage 4) physician-patient discussion, 5) patient’s interest, 6) consent, and 7) enrollment. Each step depends on the prior step (e.g. if there were no trial available then eligibility for a trial could not be considered). Reasons noted for failing any step were summarized...