Practicalities Of Detecting Rare Adverse Reactions

For reactions with no background incidence the number of patients required to give a good (95%) chance of detecting the effect is given in Table 8.1. Assuming that three events are required before any regulatory or other action should be taken, it shows the large number of patients that must be monitored to detect even a relatively high incidence adverse effect. The problem can be many orders of magnitude worse if the adverse reactions closely resemble spontaneous disease with a background incidence in the population.

Caution. About 80% of well people not taking any drugs admit on questioning to symptoms (often several) such as are commonly experienced as lesser adverse reactions to drugs. These symptoms are intensified (or diminished) by administration of a placebo. Thus, many (minor) symptoms may be wrongly attributed to drugs.

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