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

项目总结 这是一份申请HOPE联合体科学和数据行政补充的申请书 宾夕法尼亚大学研究中心(SDRC)。拟议的补编将提供 为在调查下进行HOPE试验相关的监管活动提供资金 美国食品和药物管理局颁发的新药申请(IND)。希望审判是一个 疼痛应对技能训练对减轻疼痛疗效的随机对照临床试验 长期血液透析患者的干预及阿片类药物使用。审判是 也评估部分阿片激动剂丁丙诺啡的可接受性、耐受性和疗效， 作为使用阿片类药物的试验参与者子集的全激动剂阿片类止痛药的替代药物 来管理他们的痛苦。丁丙诺啡与纳洛酮合用的临床评价 该试验将在IND下进行，因为丁丙诺啡/纳洛酮已获得上市批准 阿片类药物使用障碍，但不是为了疼痛。国家发改委负责监督和记录 所有注册地点与IND相关的活动(目前有14个，但可能会扩大到包括其他 注册站点)。这些活动包括但不限于：培训研究小组成员 所有注册站点，监控所有站点的法规活页夹，保持站点特定的最新正常 所有本地获取的实验室研究的范围，维护研究产品的责任 程序和文件，向FDA提供所有必要的方案修改，创建和 维护药物研究手册，每周向国家药品监督管理局报告不良事件 临床试验监管小组在NIDDK(赞助商)和FDA按照时间安排 要求，向FDA报告协议偏差，为FDA准备年度报告，以及 参与宾夕法尼亚大学办公室宣布或未宣布的审计 临床研究和/或FDA。该补编将提供所需的额外资金，以 开展这些在授予家长奖助金时没有预料到的重要活动。

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.