Further Investigation

When the initial assessment has indicated that there is sufficient evidence of concern to warrant further investigation, detailed consideration should be given to the most appropriate means of resolving the outstanding issues. There is no standard recipe for this process because every issue is different. The factors that are most likely to require clarification relate to causality, mechanism, frequency and preventability. Assessment of these issues may require new formal studies, but the hypothesis may be strengthened or weakened using immediately available sources of retrospective information such as epidemiological databases (Wood and Waller, 1996) (see below).

The principal epidemiological databases that are used for drug safety purposes are shown in Table 9.6. These databases have the potential to provide rapid answers to important questions, facilitating immediate risk management and the design process of definitive studies. Their individual strengths, limitations and overall utility have been well summarised by Strom (2000).

To address the key factors listed above may require laboratory, clinical or epidemiological studies. Detailed consideration of the first two are beyond the scope of this chapter, but we will consider the principles underlying the epidemiolo-gical approach in some detail.

Table 9.6. Principal databases used for drug safety studies.

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