Rescue Therapy in Dental Clinical Trials

在口腔疾病的临床研究中，检测需要抢救治疗的不良事件的标准集中在单个牙齿甚至牙齿表面细分的反应上。考虑到在一次访问中可能收集数百个测量值来评估牙齿疾病，在口腔的一个区域检测不良事件是计算密集型的。此外，只有一小部分分析对受试者安全监测是必要的。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，以识别异常更改。然后，IRB和其他监管组可以根据需要访问该查询的结果。通过对该数据库的定期监测，可以持续获得入组统计数据、救助治疗干预、研究启动和研究完成情况。实施这种制度将使内部审查委员会能够更好地监测和保护受试者的安全。数据和安全监测委员会（DSMBs）和研究课题倡导者（rsa）应根据需要扩大其在监管数据质量和课题安全方面的职能。控制对个人可识别健康信息的访问将同时实现《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。

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.