Coordination and Statistics for CoQ10 in PD in Phase 3

第三阶段 PD 中 CoQ10 的协调和统计

• 批准号: 6966695
• 负责人: David Oakes
• 金额: $ 91.37万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6966695
• 关键词: Parkinson' s disease; biomedical facility; brain disorder chemotherapy; chemoprevention; clinical research; clinical trial phase III; cooperative study; data management; disease /disorder onset; drug screening /evaluation; human subject; human therapy evaluation; patient oriented research; statistics /biometry; ubiquinone

DESCRIPTION (provided by applicant): This project will provide Coordination, Data Management and Statistical support for the conduct of a clinical trial of Coenzyme Q10 in early Parkinson's disease to be led by Dr. Flint Beat, the PI of a companion grant, 'Effects of Coenzyme Q10 in Early Parkinson's Disease - Phase 3" submitted by Weill Medical College, Cornell University (Weill). The trial will attempt to confirm & further explore a previously noted effect of Coenzyme Q10 (CoQ10) in patients with early Parkinson's disease. Specific aims of this application are:1) To develop a randomization algorithm for assigning subjects to the different treatments, to implement this as part of a password-protected EDC data-entry system, which will automatically check inclusion criteria, generate visit windows, & requests for packaging of study medication. To maintain a blindedness policy to ensure that treatment assignments are concealed from central coordination & data management staff, study investigators, coordinators & patients.2) To provide central coordination for the study, including design & distribution of electronic case report forms & the operations manual, assistance with regulatory documents and training of site personnel. To work with Dr. Seal to resolve questions regarding study conduct, including subject eligibility, exclusionary medications, reporting of adverse events & other incidents. To monitor recruitment at each site, timeliness & accuracy of submitted data. To provide activity reports to Weill from which site payments may be generated.3) To establish a system for electronic data capture and management that will ensure timeliness & accuracy of submitted data and provision of prompt & accurate study data on an ongoing basis to Dr. Beal, the Steering Committee, Sponsor & monitoring committees & allow timely publication of the results of the study at its conclusion. This system will satisfy all relevant regulatory guidelines.4) To monitor recruitment & retention at each site.5) To liaise with the pharmacy to ensure that adequate supplies of active study medication & placebo, properly labeled, are available to each study subject on as-needed basis.6) To implement a statistical analysis plan to address the primary & secondary hypotheses of the study.7) In conjunction with the NINDS Data & Safety Monitoring Board, to devise & implement an interim monitoring scheme which will allow early termination of the study on grounds of either (i) safety, (ii) overwhelming evidence of efficacy, or (iii) futility. To prepare reports for this committee including unblinded data & to maintain & document the confidentiality of such reports.

描述（由申请人提供）：该项目将为辅酶 Q10 治疗早期帕金森病的临床试验提供协调、数据管理和统计支持，该临床试验由 Flint Beat 博士领导，他是一项配套资助“Effects”的 PI辅酶 Q10 在早期帕金森病中的作用 - 第 3 阶段”由康奈尔大学威尔医学院 (Weill) 提交。该试验将试图确认并进一步探索之前注意到辅酶 Q10 (CoQ10) 对早期帕金森病患者的影响 该应用的具体目标是：1) 开发一种随机算法，用于将受试者分配给不同的治疗，并将其作为受密码保护的 EDC 数据的一部分来实施。 -输入系统，将自动检查纳入标准，生成访问窗口和研究药物包装请求，以维持盲性政策，以确保中央协调和数据管理人员、研究调查人员隐藏治疗分配。协调员和患者。2) 为研究提供中央协调，包括电子病例报告表和操作手册的设计和分发、监管文件的协助以及现场人员的培训。与 Seal 博士合作解决有关研究实施的问题，包括受试者资格、排除药物、不良事件和其他事件的报告。监控每个站点的招聘情况、提交数据的及时性和准确性。向威尔提供活动报告，从中可以生成现场付款。3) 建立电子数据采集和管理系统，确保提交数据的及时性和准确性，并持续向威尔博士提供及时、准确的研究数据。 Beal、指导委员会、发起人和监督委员会允许在研究结束时及时公布研究结果。该系统将满足所有相关的监管指南。4) 监控每个研究中心的招募和保留。5) 与药房联络，确保每个研究受试者都能获得充足的活性研究药物和安慰剂，并贴上适当的标签。 - 需要的基础。6) 实施统计分析计划，以解决研究的主要和次要假设。7) 与 NINDS 数据和安全监测委员会一起，制定和实施临时监测计划，以便提前终止研究的研究(i) 安全性，(ii) 压倒性的功效证据，或 (iii) 无效的理由。为该委员会准备报告，包括非盲数据，并维护和记录此类报告的机密性。