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An independent data monitoring committee (DMC) has been formed to monitor data and safety as this is a large clinical trial with multiple study sites. The DMC consists of subject matter experts who are not part of the EXPEL study team. An interim analysis will be performed after at least 200 subjects have completed 6‐months follow‐up. The purpose of the interim analysis is two-fold: firstly, to mitigate the risks from this trial should any unexpected serious adverse effects surface. Secondly, to allow for preliminary analysis of data to assess the efficacy of EIPL as compared with standard therapy. This would allow early closure of the trial should the efficacy be unequivocally proven, or modification of the trial with regard to increasing the sample size should it be deemed inadequate to show a more modest improvement in OS.