Enhancing clinical trials accrual in an urban hospital setting.

Abstract

e16564 Background: Facilitating clinical trials (CT) access to underserved populations in an urban hospital is an integral part of the NYUCI fellowship program. In 2009, to overcome barriers in CT enrollment at affiliate site, processes were targeted to promote awareness of available trials, simplify enrollment and enhance fellows’ participation in the CT process. This is a review of therapeutic CT accruals (TCTA) at affiliate site after reengineering the infrastructure. Methods: Under the direction of the site designated CT Medical Director and a CT nurse the CT program was comprehensively integrated into the outpatient clinic. With direct access to the faculty, fellows, patient navigators, and translation services the CT program was placed at the nucleus of clinic operations. The new infrastructure enabled education and support for investigational agent administration by the clinical staff and navigation of research patients through the complex medical system. It further increased visibility of the program and information on available trials. Lists of available trials were disseminated monthly to fellows, attending physicians, and major referring centers. Information about newly activated studies was disturbed to treating providers electronically. CT education sessions were offered to patients through support groups. New clinic patients were tracked and reviewed twice monthly for possible CTA. The affiliate CT leadership liaised with key personnel in the NYU CI and affiliate hospital to prioritize and promote appropriate CT and their activations. Results: TCTA from years ’07 through ‘10 were evaluated and analyzed. TCTA was stable from ‘07-‘09, and raised significantly in ‘10, 61%, as a result of these interventions. In ‘09, 30% (13/38) TCTA were enrolled by fellows, under the guidance of an investigator. In ‘10, patients enrolled on CT by fellows rose to 50% (30/61). Conclusions: With the centralized CT program, supported by fulltime research staff, visibility was increased and the enrollment process was simplified. Subsequently motivation of the fellows was increased, improving hands-on education in the CT process. As a result, there was more active screening and enrollment—which led to an approximately 61% increase TCTA in one year.