UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis

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PROJECT SUMMARY This is an application for an administrative supplement for the HOPE Consortium Scientific and Data Research Center (SDRC) at the University of Pennsylvania. The proposed supplement will provide funding for regulatory activities associated with conducting the HOPE Trial under an Investigational New Drug application (IND) issued by the US Food and Drug Administration. The HOPE trial is a randomized controlled clinical trial testing the efficacy of pain coping skills training to reduce pain interference and opioid use for patients with chronic undergoing long-term hemodialysis. The trial is also evaluating the acceptability, tolerability, and efficacy of buprenorphine, a partial opioid agonist, as an alternative to full agonist opioid pain medication for the subset of trial participants using opioids for management of their pain. The evaluation of buprenorphine in combination with naloxone requires that the trial be conducted under an IND because buprenorphine/naloxone has marketing approval for opioid use disorder but not for pain. The SDRC is responsible for the oversight and documentation of IND-related activities at all of the enrolling sites (currently 14 but likely to expand to include additional enrolling sites). These activities include, but are not limited to: training of research team members at all enrolling sites, monitoring regulatory binders at all sites, maintaining up-to-date site-specific normal ranges for all locally acquired laboratory studies, maintaining investigational product accountability procedures and documentation, providing all required protocol modifications to the FDA, creating and maintaining an investigational drug brochure, reporting adverse events on a weekly basis to the clinical trials regulatory group at the NIDDK (sponsor) and to the FDA in accordance with the timing requirements, reporting protocol deviations to the FDA, preparing annual reports for the FDA, and participating in announced or unannounced audits from the University of Pennsylvania Office of Clinical Research and/or the FDA. The supplement will provide the additional funding required to carry out these important activities that were not anticipated when the parent grant was awarded.