Disease natural history is a broad term that reflects the events and outcomes that characterize the course of illness. It has been referred to as "background rate'', "background noise'', or expected rate in the pharmacovigilance world. For acute disease such as many infections, the natural history may be relatively simple and uncomplicated as in the case of wound infections or acute otitis media. For chronic disease, the picture can be drastically different as over time, different events may present themselves and the passage of time itself increases the likelihood that other illnesses or exposures may exert an influence. The natural course of disease is a dynamic process with variations in severity, comorbidities and exacerbations over time. Knowledge of the disease natural history provides the context against which the risk and benefit of any therapy can be judged. One need only look at the CIOMS IV recommendations to see the integral role of these data in providing the context for risk tolerance and assessment of the risk-benefit profile of a product (CIOMS IV, 1998). This chapter will outline the relevant concepts of disease natural history and how they are applicable to pharmacovigilance.

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