ABSTRACT
The increasing complexity of clinical trials and the reinforcement of quality standards focused on drug safety have caused regulators to recommend to pharmaceutical companies that they pay attention to truly important matters. The fundamental time series analysis (TSA) was applied to real clinical data dating back a few years. All of the applied models diagnosed time series well, providing characteristics of medical variables monitored for that time. Moreover, the forecast turned out to be useful as a reference point for new data collected. TSA supports monitoring of clinical trials providing diagnostics of the medical parameter change for that time and helping to detect unwanted data patterns and predict future results as well. The results of the analysis are promising, but there are other variations of this method which should be tested on a broader spectrum of clinical data to enrich central statistical monitoring practice.
