Gulf South Minority/Underserved Clinical Trials Network (Gulf South M/U CTN)

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Virtual Research Nurse Program (VRN) Addressing Clinical Trials Research Personnel Shortage Most adult cancer patients in the US are diagnosed and treated in community oncology practices. However <5% of patients participate in clinical trials, thus limiting the testing and implementation of scientific advances in “real world” settings. In addition to the well described patient and physician related barriers to clinical trials, the recent changes to the workforce brought about by the COVID-19, including “work from home” initiatives have greatly decreased the number of trained clinical trials personnel. These changes more severely affect community oncology practices in both urban and rural locations where research infrastructure is limited and the ability to adapt to these changes is difficult. The Gulf South NCORP community sites have experienced a severe reduction in accruals due primarily to research personnel shortage. We established a “Virtual Research Nurse” program to provide research infrastructure (regulatory, data management and research nurse) to community sites through virtual means. Using a HIPAA-compliant communication platform we have helped urban and a rural oncology practices select and open clinical trials of interest, screen and identify candidate patients and facilitate their enrollment and follow-up. This approach is distinct from traditional telemedicine, in that telemedicine primarily provides physician services to a distant clinical location, while the VRN program provides the research infrastructure and functions to community oncologists seeking to enroll patients in clinical trials. Our preliminary data shows that a centrally located VRN efficiently screens the community clinics, identifies potential candidates for clinical trials and with the community oncologist enrolls patients on clinical trials. The VRN also provides long-term management of the patient. Furthermore, in collaboration with Medidata Solutions we will further streamline the implementation of VRN by ensuring that data collected is seamlessly transferred to the RAVE system, thus minimizing the error-prone process transcribing data by hand. We believe that the VRN will significantly facilitate the participation of community oncology practices and patients in clinical trials and help address the severe shortage of trained clinical trials personnel and research infrastructure. We propose to: Specific Aim 1a. Complete the development of the VRN prototype in collaboration with Medidata Solutions to have a fully functional platform that can be used in NCORP sites. This will be a Proof Of Concept (POC) program designed to demonstrate the use of technology, training, and clinical trial expertise to support these clinics and patients. 1b. Expand the number of sites to test the integrated VRN program to 4 sites (2 urban and 2 rural) to determine and compare the effect of implementing a VRN program at community oncology practices in urban and rural locations. Aim 2: Develop standard operating procedures (SOPs) for the implementation of the VRN program at other clinical centers.