Evaluation of barriers to clinical trial enrollment through a novel pharmacy quality assurance tool

Abstract

17026 Background: Clinical trials offer the best treatment for patients with cancer, yet less than 5 percent of adults and less than 60 percent of children are enrolled on clinical trials. To determine reasons for lack of enrollment on clinical trials and to assess areas for potential trial development, we designed a ‘non-protocol’ form for use at our center. Our goal was to assess deficiencies in our menu of trials, identify other barriers to enrollment, and to indirectly increase awareness of trials. Methods: Completion of a ‘non-protocol’ form was required by the pharmacy with the first set of new chemotherapy orders for all Cancer Institute of New Jersey ambulatory patients who were not enrolled on a clinical trial. The form required completion of one of three areas for lack of enrollment: trial availability, reason for ineligibility, or other reason for not enrolling the patient. Results: From June 2003 through December 2005, 474 forms were collected for patients not enrolled on a clinical trial. The median age of patients not enrolled on trial was 56 years (range 1 to 88 years) and females outnumbered males (69% vs 31%). Lack of trial availability limited enrollment for 51% of patients (n=241) while administration of standard therapy was listed for 10 patients. Of those patients where a trial was available (n=223), 65% (n=145) of patients were not eligible, most commonly due to performance status (n=55). The remaining 78 patients refused participation. To determine if implementation of this pharmacy service changed the reasons for lack of enrollment, the data was evaluated by year: Conclusion: Lack of trial availability has been a rate-limiting factor in enrollment on clinical trials at our center. The data generated from the implementation of this novel pharmacy service is of strategic importance to the center. It is reviewed with the tumor-focused groups of the cancer center to identify areas for developing clinical trials. [Table: see text] No significant financial relationships to disclose.