MonitoringMonitoring

C-TASC staff routinely monitor ongoing studies for: performance, quality of submitted materials, the occurrence of excess numbers of adverse events in a clinical trial, and for the demonstration of outstanding efficacy. Performance and quality control has to do with ensuring that clinical sites are recruiting the number of patients necessary to complete your clinical trial in a specified interval of time, and that the data arriving at the coordinating center are of sufficient quality to allow the statistical decision for the trial to be made about whether or not a particular treatment or biomarker is a useful tool in the medical armamentarium. Sequential monitoring for efficacy, safety and toxicity, is also carried out during a trial to ensure that no patient group is unduly exposed to adverse treatments over the course of the clinical trial. C-TASC staff routinely use methodologies such as Pocock and Obrien-Fleming sequential monitoring boundaries and Lan-DeMets spending functions to determine when one treatment group is receiving a substantially better treatment than another treatment group. This finding can precipitate the early closure of a clinical trial which demonstrates outstanding benefit to the treatment population. Such monitoring boundaries are valuable since they minimize the cost to a research sponsor that is trying to develop a biomarker, treatment or device for public use. Let us help you design your statistical analysis plan and protocol to take advantage of these important statistical tools for conducting clinical trials.