부산대학교 도서관

A specialized research team is integral to the successful implementation of a clinical trial (CT) program. A cancer institute that is partnered with hospital and ambulatory clinical care provides the opportunity to offer innovative scientific and disease focused research programs. The increasing number of complex CTs presents challenges that are coupled with increasing regulatory requirements and economic constraints. Collaborating with all members of the interdisciplinary team is key to achieving a successful CT program. A task force was organized to develop a CT tracking tool that describes all elements of a clinical trial, and identify the members of the interdisciplinary team who are accountable for each element. The purpose of the tool was to clarify each member's role and promote utilization of essential team member's skills and knowledge in order to decrease duplication of effort and increase communication among the interdisciplinary team. A CT tracking tool that includes elements of a clinical trial including protocol pre-activation, screening, eligibility, informed consent, active treatment, regulatory/ economic components, quality improvement, patient tracking and reporting was developed. Included in this tool is a column indicating responsible individual (principal investigator, research RN, infusion RN, data management, regulatory, pharmacy, lab, and clinical trials office). Nurse to clinical trial ratio based on complexity and nursing time was defined. A weekly CT interdisciplinary feasibility meeting was organized to ensure that resources needed to address the above listed CT elements were available prior to a trail going to the IRB. The CT team has a streamlined system that facilitates the flow of the trials demonstrated by less time spent in trouble shooting after a trail has been approved. Transparency regarding work load and need for cross coverage was established. Regulatory and financial documentation have improved while enrollment to clinical trials continues to steadily increase. Including stakeholders in the development and implementation of the CT tracking tool successfully fostered partnerships among members of the research program. [ABSTRACT FROM AUTHOR]