This study sought to determine the nature of clinical trials opened at the authors' institution from 1999 to 2004, the proportion of patients to whom trials appropriate for their type and stage of cancer were available, and the trial accrual rate. Retrospective analysis showed that, from 1999 to 2004, 207 trials were open, and 5,776 new adult cancer patients were seen. Appropriate trials were available for only 60% of patients. The number of trials opened (P = 0.001) and the availability of appropriate trials (P = 0.008) increased steadily over time. Overall, 103 patients (accrual rate, 1.8%) were enrolled. When only patients with an available trial were considered, the accrual rate was 3%. These results confirm earlier findings showing that protocol unavailability is a major barrier to clinical trial accrual among newly diagnosed adult cancer patients in the community. If eligibility criteria are applied, an estimated < 50% of patients will have trials available. With several thousand cancer clinical trials open in the United States, the major problem is not a lack of trials but poor access to them.
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