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

HOPE 联盟的 UPENN 科学和数据研究中心旨在减少血液透析中的疼痛和阿片类药物的使用

• 批准号: 10469886
• 负责人: Laura M Dember
• 金额: $ 36.63万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10469886
• 关键词: Accountability; Administrative Supplement; Adverse event; Annual Reports; Award; Buprenorphine; Chronic; Clinical Research; Clinical Trials; Coping Skills; Data; Documentation; Enrollment; Evaluation; Funding; Hemodialysis; Investigation; Investigational Drugs; Investigational New Drug Application; Kidney Failure; Laboratory Study; Marketing; Modification; Monitor; Naloxone; National Institute of Diabetes and Digestive and Kidney Diseases; Normal Range; Opioid Analgesics; Opioid agonist; Pain; Pain interference; Pamphlets; Participant; Patients; Pennsylvania; Procedures; Protocols documentation; Randomized Controlled Clinical Trials; Reporting; Research; Research Training; Safety; Site; Suboxone; Testing; United States Food and Drug Administration; Universities; chronic pain management; efficacy testing; member; opioid use; opioid use disorder; pain reduction; parent grant; prescription opioid; skills training

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.

项目摘要 这是一份希望科学和数据联合会的行政补充申请 研究中心（SDRC）在宾夕法尼亚大学。拟议的补编将提供 根据研究性试验开展HOPE试验相关监管活动的资金 美国食品药品监督管理局发布的新药申请（IND）。希望审判是一个 一项随机对照临床试验，测试疼痛应对技能训练减轻疼痛的效果 长期血液透析患者干预与阿片类药物应用审判 还评估了丁丙诺啡，一种部分阿片激动剂， 作为使用阿片类药物的试验受试者子集的完全激动剂阿片类疼痛药物的替代药物 来控制他们的疼痛丁丙诺啡联合纳洛酮的评价需要 试验在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，但不是疼痛。SDRC负责监督和记录 所有入组研究中心的IND相关活动（目前为14个，但可能会扩大到包括其他研究中心） 注册站点）。这些活动包括，但不限于：培训研究小组成员， 所有入组研究中心，监测所有研究中心的监管文件夹，保持最新的研究中心特定正常 所有当地获得的实验室研究的范围，维持试验用药品清点 程序和文件，向FDA提供所有必要的方案修改， 维护研究药物手册，每周向 NIDDK（申办者）的临床试验监管组，并根据时间安排提交给FDA 要求，向FDA报告方案偏离，为FDA准备年度报告，以及 参与宾夕法尼亚大学办公室的宣布或未经宣布的审计， 临床研究和/或FDA。补充资金将提供所需的额外资金， 开展这些在发放母公司赠款时没有预料到的重要活动。