Safety data collection

The required data must be collected prior to the risk analysis. This can be done gradually during process development as the knowledge on the process increases. The data can be summarized on data sheets devoted to different aspects of the process. They typically should encompass the following  

The required data are reviewed in detail in Section 1.4. In order to be economic and efficient, the data collection is accompanied by their interpretation in terms of risks. This allows adapting the amount and accuracy of the data to the risk. This procedure is illustrated in the example of thermal data in Section 3.4. 

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In the evaluation of safety in the postmarketing phase, regulatory agencies are greatly more restricted in their enthusiasm for data derived from some of the methods available than from others. Indeed, the EC national agencies separately and the CPMP collectively have developed a legislative framework that is predominantly concerned with spontaneous adverse event monitoring and which is, for all practical purposes, silent on the matter of safety data collected by other methods. 

The previous chapter discussed the (currently) relatively loosely defined statistical approaches to safety data collected in clinical trials. In contrast, there are widely accepted statistical methods for demonstrating efficacy in clinical trials. As has been noted several times in this book, if the study design and methodology have been appropriate and have led to the collection of optimum quality data, the statistical analysis and interpretation of efficacy data are relatively straightforward. The clinical (biological) interpretation of efficacy data is typically not quite as clear-cut, but there are widely accepted methodologies that are very useful in this realm too. Of particular importance here is the expert judgment of the clinicians who will review the statistical results with the statisticians and the rest of the study team. 

Spontaneous adverse event reporting may be defined as any system of safety data collection which relies upon physicians, other healthcare workers and sometimes patients to report adverse clinical events which, they suspect, may be causally related to the administration of a drug or drugs. It is these systems which are sponsored by the governments of virtually all developed countries and, increasingly, by developing countries as well. For the physician in the pharmaceutical industry it is this method of safety evaluation that will most frequently be encountered and, in spite of its numerous defects and limitations, will take up much working time. 

Companies employing these analytics techniques to prevent workplace injuries and safety incidents see dramatic results. The graphics to the right are examples of actual companies who reduced their incident rates (red line) through increased safety data collection and use of advanced analytics (green line). 

Reliability and Safety Data Collection and Analysis Fault Identification and Diagnostics Maintenance Modelling and Optimisation Structural Reliability and Design Codes Software Reliability Consequence Modelling Uncertainty and Sensitivity Analysis Safety Culture Organizational Learning Human Factors... 

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