Rescue Therapy in Dental Clinical Trials

牙科临床试验中的救援治疗

• 批准号: 6591098
• 负责人: Jo MAX GOODSON
• 金额: $ 10万
• 依托单位: ADA FORSYTH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-09-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591098
• 关键词: clinical trials; computer system design /evaluation; dentistry; health science research; health science research support; information systems; patient safety /medical error

The criterion for detection of adverse events that require rescue therapy in clinical studies of dental diseases is focused on responses at individual teeth or even subdivisions of surfaces of teeth. Considering that hundreds of measurements may be collected at a single visit to evaluate dental disease, detection of an adverse event at one area of the mouth is computationally intensive. Furthermore, only a subset of analyses are necessary for subject safety monitoring purposes. The current proposal creates a computer database structure from which a target array is evaluated by a query constructed to identify a exceptional change. The results of this query would then be made accessible by the IRB and other regulatory groups as required. By regular monitoring of this database, enrollment statistics, rescue therapy interventions, study initiation and study completion would be continuously available. Implementation of such a system would place the IRB in a better position to monitor and protect subject safety. Extension as required to Data and Safety Monitoring Boards (DSMBs) and Research Subject Advocates (RSAs) should facilitate their function in regulation of data quality and subject safety. Controlling access to the individually identifiable health information would at the same time implement subject privacy as mandated by the Final Privacy Rule, the Common Rule and the FDA's human subjects regulations.

在牙科疾病的临床研究中，需要补救治疗的不良事件的检测标准集中在单个牙齿甚至牙齿表面的细分部分的反应。考虑到在一次访问中可能收集数百个测量结果以评估牙科疾病，在口腔的一个区域处检测不良事件是计算密集型的。此外，出于受试者安全性监测目的，仅需要分析的一个子集。当前的建议创建了一个计算机数据库结构，通过构造一个查询来评估目标数组，以识别异常变化。然后，IRB和其他监管机构可根据需要访问该查询的结果。通过定期监测该数据库，可持续获得入组统计数据、补救治疗干预、研究启动和研究完成。实施该系统将使IRB能够更好地监测和保护受试者安全。数据和安全监测委员会（DSMB）和研究受试者倡导者（RSA）的必要扩展应有助于其在数据质量和受试者安全监管方面的职能。控制对个人可识别健康信息的访问将同时实施最终隐私规则、通用规则和FDA人类受试者法规所规定的受试者隐私。