Rescue Therapy in Dental Clinical Trials

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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.