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Abstract:
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An adaptive group sequential analysis was conducted in a medical device clinical trial. Primary endpoint was the change of Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score at Week 26. The study was designed to have 2 interim analyses with possibility of early stopping and sample size re-estimation. Due to fast enrollment most of the subjects were enrolled at the time of the first interim analysis. An unblinded statistician was used to minimize operational bias for the adaptation. A study specific procedure was also written to document data management, clinical, inventory control, biostatistics, and programming roles and responsibilities at the start of the trial. Upon submitting to the regulatory agency, they had some concerns with the results due to the increase in effect over the three stages. We will discuss the regulatory agency's issues and how we responded to their concerns. Conclusions from the regulatory agency final determination will be provided if available. Other analyses will also be presented which were done to further explore alternative endpoints that could have been used to increase the power for the interim looks
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