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- W2227146237 abstract "6010 Background: While barriers to clinical trials are well known, there is a paucity of literature concerning the structural, infrastructural, and procedural barriers that take place outside the realm of the patient-physician interaction. For example, the time required prior to opening a trial can span from 8 to 16 months, which detracts from the time available to enroll patients. Our study assesses the impact of these barriers in such areas as time to institutional review board acceptance, number of committees requiring approval prior to opening a study, and the number of signatures required. Methods: The setting is the Vanderbilt-Ingram Cancer Center (VICC), a NCI designated Comprehensive Cancer Center. Using process design methodologies, we completed interviews with all major stakeholder groups and developed comprehensive process flow map and four sub-maps for: Institutional Review Board, Scientific Review Board, Clinical Trials Office, and General Clinical Research Center. Results: Over 80 major steps required to begin a clinical trial were documented. Each of these steps may require repetition, as initiation of any trial is a negotiated process among the investigator, the sponsor, and the internal system. We discovered that over 27 different groups or individuals are involved in the approval process and, before any trial can be opened, from 16 to 27 signatures are required. Conclusions: We have completed this analysis at one comprehensive cancer center and have plans of extending the methodology to document process flows at the VICC Affiliate Network and selected Affiliate sites that include community hospitals and private oncology practices. Future direction for this research is to utilize process redesign techniques to streamline the process. Support for the research was provided by the Vanderbilt Discovery Grants Program. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Vanderbilt Discovery Grant" @default.
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- W2227146237 date "2004-07-15" @default.
- W2227146237 modified "2023-09-24" @default.
- W2227146237 title "Structural, infrastructural and procedural barriers to oncology clinical trials" @default.
- W2227146237 doi "https://doi.org/10.1200/jco.2004.22.90140.6010" @default.
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