Innv-15. optimizing the role of the advanced practice provider in the management of a single patient investigational new drug (ind)

Abstract BACKGROUND Single patient Investigational New Drug (IND) applications are a way through which experimental therapies may be accessed by patients with cancer especially if a clinical trial is not available. However, initiating and managing a single patient IND is complex. We will outline our approach used at an academic teaching center to leverage the skills and scope of practice of advanced practice providers (APPs) to facilitate successful initiation and monitoring of individual patients who may be receiving an investigational drug under a single patient IND. METHODS We describe a single case of a 52-year-old male with a left thalamic glioblastoma treated with standard of care and monitored off therapy from May 2021 until November 2022. Extended genomic profiling of his tumor at time of biopsy revealed a FGFR3-TACC3 fusion and MGMT promoter methylation, and the decision was made to pursue a single patient IND for anlotinib for use in combination with temozolomide. RESULTS Following permission from the US Food and Drug Administration (FDA) to proceed and IRB chair concurrence, the MD and APP conferred with the investigational and clinical pharmacists regarding procurement and dispensing of the drug, in addition to surveillance and associated toxicities. The APP obtained consent, collected data on monitoring parameters and adverse events, checked for drug interactions with the patient’s routine medications, ordered and reviewed all treatment related MRIs, labs, and EKGs, and coordinated with ophthalmology for baseline and monthly eye exams. Performance of initial and follow-up exams, ongoing toxicity review and management, and care coordination with the local oncology team were completed by the APP. CONCLUSION As first point of contact for the patient and family, the APP plays a key role in glioma research within the multidisciplinary team by providing ongoing symptom management, education, and monitoring for patients receiving investigational drugs.