Sarah Cannon Research Institute, Nashville, TN
Patricia Sandra Graham , Renee Yvonne Smith , Patricia A. Hurley
Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist the development and implementation of high-quality research programs. A series of papers was published to elaborate on the standards and attributes. Respondents to a needs assessment survey of community-based research programs confirmed a gap/need for a quality assessment tool. ASCO’s Community Research Forum sought to develop a tool to assist community-based research sites in the development and implementation of an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to help community-based research sites exceed minimum standards of conducting clinical research and provide an overview of ASCO’s recommendations of important components for internal quality assurance programs. A checklist tool was developed to help sites conduct an assessment of their program. Community-based researchers provided feedback about content and utilization in community-based research programs. Reviewers completed an online survey. Results: Sixteen community-based physician investigators and research staff completed the online survey. All respondents indicated the detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. Feedback from Community Research Forum’s Annual Meeting participants was favorable. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and may rely heavily on external audits. Resources should be allocated to create an internal quality assurance problem providing for self-directed continual process improvement. The ASCO Research Program Quality Assessment Tool provides methods to help community-based research sites exceed the minimum standards of conducting clinical research. The tool will be made available to the public in 2014.
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Abstract Disclosures
2014 ASCO Quality Care Symposium
First Author: Patricia A. Hurley
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