NeuroREACH™ Platform for Expanded Access Program (EAP) Trials as the Foundation for Clinical Research of the Future (5463)

摘要: Objective: Develop a platform for rapid deployment of neurological EAP clinical trials to test investigational therapies and aggregate safety data in compliant regulatory setting Background: Expanded Access Programs provide patients who are not eligible or able participate but have serious life-threatening diseases, which their physician has determined there no appropriate treatment options. Many pharma/biotech offer products many investigators agreeing insisting upon running multiple the benefit patient population fail eligibility criteria “regular” trials. Introduction regulatory-compliant execute EAPs became necessity. The Center Innovation Bioinformatics (CIB) introduced NeuroREACH™ facilitate: - Rapid Capture from Data Management Real-time secure controlled access visualization reports Design/Methods: Any investigator with an IRB-approved protocol open enrollment may capture store phenotypical, safety, biomarker utilizing NeuroREACH EDC platform. CIB acts as Coordination its program management team will oversee addition new studies, curation, visualization, reporting. Results: been deployed at available sponsors around world. Currently FOUR utilize NeuroREACH. As EAPs, NeuroGUIDs/NeuroSTAmPs used uniquely identify participants across studies. Study drug manufacturers dashboards track real time. Conclusions: become more prevalent method even efficacy, study use rapidly deploy captured information utilized by indications, analyses, negotiations FDA insurance companies Disclosure: Yes My institution received research funding on my behalf Amylyx Pharmaceuticals, Origent Sciences, Mitsubishi Tanabe Pharma AmericaDr. Podesta nothing disclose. Dr. Walker Yu D’Agostino Tarasenko Sinani Luppino Scalia Paganoni support Amylyx.Dr. Cudkowicz personal compensation consulting, serving scientific advisory board, speaking, other activities takeda, biogen, cytokinetics, sunovian, immunitypharm, avexis.