Data Coordinating Center for Pilot Studies of Candidate Therapies for CKD

慢性肾病候选疗法试点研究数据协调中心

• 批准号: 8585720
• 负责人: JENNIFER J GASSMAN
• 金额: $ 49.76万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-16 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8585720
• 关键词: 18 year old; 21 year old; Address; Adherence; Adult; Adverse effects; Adverse event; Allopurinol; American; Ancillary Study; Angiotensin Receptor; Angiotensin-Converting Enzyme Inhibitors; Archives; Biological Markers; Blinded; Caring; Child; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Consent; Core Facility; DNA Repository; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Databases; Development; Diabetes Mellitus; Dialysis procedure; Disease Progression; Documentation; Dose; Eligibility Determination; Enrollment; Ensure; Environment; Evaluation; Face; Genetic; Health; Health Sciences; Human Resources; Hypertension; Institutional Review Boards; Kidney Diseases; Kidney Failure; Laboratories; Legal; Link; Logistics; Manuals; Methods; Monitor; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Online Systems; Outcome; Participant; Patients; Peer Review; Pharmaceutical Preparations; Pilot Projects; Placebos; Process; Protocol Compliance; Protocols documentation; Publications; Publishing; Randomized; Reading; Recruitment Activity; Reporting; Research Design; Research Personnel; Resolution; Safety; Sampling; Scientist; Secure; Serious Adverse Event; Serum; Site; Specimen; System; Testing; Training; Transplantation; United States National Institutes of Health; Uric Acid; Visit; Work; abstracting; aged; arm; cardiovascular risk factor; data exchange; data management; design; drug distribution; experience; follow-up; meetings; operation; prevent; randomized trial; repository; sound; web based interface; web site

DESCRIPTION (provided by applicant): The DCC for the Pilot Studies of Candidate Therapies project will carry out the following tasks: "assist the Steering Committee in its evaluation and finalization of Pilot Studies. For each approved trial, the DCC will work with the SC to develop a Manual of Operations and data collection forms, a customized data management system with a Web-based data entry interface and a secure Oracle 10gR2 database and establish a web site for each Pilot Study. Web sites will include all study documentation and a link to that study's secure data entry system " train clinical center and central facilities personnel on data collectio, data entry, and data discrepancy resolution and the requirements for each approved pilot study " assist the Clinical Centers in a) participant recruitment, retention, and adherence to treatment arm and b) site adherence to the study protocols and to IRB and regulatory requirements " maintain a high quality database of each pilot study's data and provide periodic reports to the Steering Committee, the Data Safety and Monitoring Board , and the NIH Project Office on each Pilot Study, including progress on recruitment, protocol compliance, retention, subject safety, and data quality " work with the Collaborative Study Group (CSG) to performing data analyses for abstracts, presentations and peer-reviewed publications " manage the logistics, administration, and project-wide regulatory requirements for the Pilot Studies " establish cores such as central labs, drug distribution centers, and reading centers as required by the study " orchestrate the transfer of biologic samples to the NIDDK Bio-specimen and Genetic Repositories and ensure archiving of each Pilot Study's data in the NIDDK Data repository The DCC also proposes a Pilot Study. Should the DCC protocol be selected and finalized by the Steering Committee, the DCC would coordinate a 36-month pilot clinical trial of allopurinol vs placebo, with 12 months of randomization and a minimum of 24 months follow up per patient. With 200 patients (100 in each arm), this Pilot Study would be larger than all previous published trials of allopurinol in CKD. This Pilot Study would enable the CSG to evaluate challenges to drug distribution, recruitment, retention, follow up data collection (including laboratory data), data quality, participant compliance and clinical center adherence to protocol requirements. The Pilot Study would be powered to detect a 2-year change in a reasonable biomarker (eGFR estimated by MDRD-4). This Pilot Study would provide additional scientific justification for a full scale trial of allopurinol. It would also demonstrate the challenges of conducting such a trial, allowing these challenges to be addressed before the full scale study begins and thus enabling a scientifically sound full scale study with a hard endpoint outcome to be implemented efficiently.

DESCRIPTION (provided by applicant): The DCC for the Pilot Studies of Candidate Therapies project will carry out the following tasks: "assist the Steering Committee in its evaluation and finalization of Pilot Studies. For each approved trial, the DCC will work with the SC to develop a Manual of Operations and data collection forms, a customized data management system with a Web-based data entry interface and a secure Oracle 10gR2 database and establish a web site for each Pilot Study. Web sites will include all研究文档以及与该研究的安全数据进入系统的链接“培训临床中心和中心设施人员有关数据收集，数据输入以及数据差异的解决方案以及每个批准的试点研究的要求“协助临床中心a）参与者招募，保留率，保留和依从性，并遵守治疗方案和b）对IRB和监管机构保持较高的数据，并保持较高的数据，并保持较高的质量质量，并保持较高的质量质量质量的质量， to the Steering Committee, the Data Safety and Monitoring Board , and the NIH Project Office on each Pilot Study, including progress on recruitment, protocol compliance, retention, subject safety, and data quality " work with the Collaborative Study Group (CSG) to performing data analyses for abstracts, presentations and peer-reviewed publications " manage the logistics, administration, and project-wide regulatory requirements for the Pilot Studies " establish cores such as central labs, drug distribution研究中心和阅读中心按照研究的要求“协调生物样品转移到NIDDK生物特异性和遗传库中，并确保在NIDDK数据存储库中归档每个PILOT研究数据的数据DCC还提出了一项试验性研究。如果DCC方案由指导委员会选择并确定，DCC将协调另类酚与安慰剂的36个月试验临床试验，每位患者进行12个月的随机分组和至少24个月的随访。这项初步研究有200名患者（每只手臂为100例），将比CKD中所有其他素素醇的试验大。这项试点研究将使CSG能够评估药物分配，招聘，保留，后续数据收集（包括实验室数据），数据质量，参与者合规性和临床中心遵守协议要求的挑战。试点研究将有助于检测合理生物标志物的2年变化（MDRD-4估计的EGFR）。这项试点研究将为全面提供额外的科学理由 别嘌醇的比例试验。这也将证明进行此类试验的挑战，使这些挑战在全面研究开始之前可以解决，从而使科学合理的完整研究能够有效地实施，并有效地实施了硬性终点。