Use of a relapse monitoring board: an independent assessment for determining relapse in clinical trials for XXXX .

@entity1 @entity162 @entity1090
OBJECTIVE: Independent review boards can provide an objective appraisal of investigators' decisions and may be useful for determining complex primary outcomes, such as @entity162 relapse, in crossnational studies. This article describes the use of an independent, blinded relapse monitoring board to assess the primary outcome (relapse) in an international clinical trial of @entity1090 long-acting therapy adjunctive to standard-care pharmacotherapy for @entity1 with @entity162 . DESIGN: The fully autonomous relapse monitoring board was composed of a chair and two additional members-all psychiatrists and experts in the diagnostic, clinical, and therapeutic management of @entity162 . The relapse monitoring board met six times during the study to review @entity1 relapse data and was charged with the responsibility of determining if the events described by investigators qualified as relapses. Additionally, the relapse monitoring board reviewed data for all randomized @entity1 to identify any relapse events not recognized by investigators. RESULTS: Primary efficacy results were similar and significant for investigator- and relapse monitoring board-determined relapses. Ten discrepancies were noted: two of the 42 investigator-determined relapses did not meet the intended clinical relapse threshold as determined by the relapse monitoring board; conversely, the relapse monitoring board confirmed eight relapse events not identified by investigators. The relapse monitoring board had no direct interactions with @entity1 and had to rely on the accuracy of investigator assessments. Also, once an investigator determined a relapse and the @entity1 discontinued the study, less information was available to the relapse monitoring board for relapse assessment. CONCLUSIONS: Use of the relapse monitoring board supported the validity of the study by incorporating a level of standardization to mitigate the risk that local practice in different cultures and medical systems at the sites would confound study results.
