Keywords: Data Monitoring Committees, interim data analysis
The Data Monitoring Committees (DMC) and the sponsor share the responsibility for overall safety and integrity of the trial. The DMC review interim unblinded data on a regular basis, and recommend the sponsor on continuation of the study with or without protocol modification or discontinuation of the study for safety or other concerns. It’s important to have these interim analyses be conducted by an independent statistician who is either not a DMC member or sponsor trial statistician. The independent statistician responsibilities include but not limit to drafting DMC charter, receiving data, preparing open and closed report, presenting unblinded results to the DMCs, recording meeting minutes, conveying the DMC recommendations and additional request to the sponsor, performing additional analysis, and conduct ad hoc meetings. Having a competent independent statistician is essential. In this presentation, we will focus on three important aspects that a successful independent statistician has: solid statistical knowledge on clinical trials and interim data analysis, knowing “do’s” and “don’ts”, and effective communication skills. Details will be further elaborated.