A keen understanding of the natural course of illness should be considered a critical component of any assessment of drug risk or benefit. Although a daunting task that does not lend itself to the rapid assessments that are often necessary, these data provide the critical context against which all events should be evaluated. The acquisition, integration and application of these data into the safety surveillance process require an ongoing commitment; however, the data can be continually referred to and elaborations made on different parts as the need arises or as data become available. These data can also be applied to other areas in the drug development and safety assessment areas.

Its important for the pharmacovigilance professional to have a good understanding of the natural course of an illness; otherwise he or she may well be blinded to the indication for therapy. It will take an investment in time and resource, but it will help you to understand what you don't know. By the same token, it is important to know what you don't know, but could.

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