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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要这是 HOPE 科学与数据联盟的行政补充申请宾夕法尼亚大学研究中心（SDRC）。拟议的补充将提供为与开展研究性 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）。 HOPE 试验是随机对照临床试验测试疼痛应对技能训练减轻疼痛的功效对接受长期血液透析的慢性患者的干扰和阿片类药物的使用。审判是还评估丁丙诺啡（一种部分阿片类药物激动剂）的可接受性、耐受性和功效，作为使用阿片类药物的试验参与者子集的完全激动剂阿片类止痛药的替代品来控制他们的疼痛。丁丙诺啡与纳洛酮联用的评估需要该试验应根据 IND 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。 SDRC 负责监督和记录所有招募地点（目前有 14 个，但可能会扩大到包括其他招募地点）的 IND 相关活动报名网站）。这些活动包括但不限于：对研究团队成员进行培训所有注册站点，监控所有站点的监管粘合剂，维护最新的特定站点正常状态所有本地获得的实验室研究的范围，保持研究产品的责任程序和文件，向 FDA 提供所有必需的方案修改，创建和维护研究药物手册，每周向主管部门报告不良事件 NIDDK（主办方）和 FDA 的临床试验监管小组根据时间安排要求，向 FDA 报告方案偏差，为 FDA 准备年度报告，以及参加宾夕法尼亚大学办公室的宣布或突击审核临床研究和/或 FDA。该补助金将提供所需的额外资金开展这些在授予家长补助金时没有预料到的重要活动。