ABSTRACT

In clinical trials, it is not uncommon to perform data safety monitoring and/or interim analyses based on accrued data up to a certain time point during the conduct of a clinical trial. The purpose is not only to monitor the progress and integrity of the trial, but also to take action regarding early termination (if there is evidence that the trial will put subjects at an unreasonable risk or the treatment is ineffective) or modifications to the study design in compliance with ICH GCP for data standards and data quality. In most clinical trials, the primary reasons for conducting interim analyses of accrued data are probably due to (Jennison and Turnbull, 2000): (i) ethical consideration, (ii) administrative reasons, and (iii) economic constraints. In practice, since clinical trials involve human subjects, it is ethical to monitor the trials to ensure that individual subjects are not exposed to unsafe or ineffective treatment regimens. When the trails are found to be negative (i.e., the treatment appears to be ineffective), there is an ethical imperative to terminate the trials early. Ethical consideration indicates that clinical data should be evaluated in terms of safety and efficacy of the treatment under study based on accumulated data in conjunction with updated clinical information from literature and/or other clinical trials.