Epidemiological studies the most comprehensive source of data

Quantitative estimates of risks associated with drug use may be obtained from analytic epidemiology studies (i.e. cohort and case-control studies),13 and from a number of modifications of these traditional study designs pertaining to the broad area of pharmacoepidemiology (Box 10.2). These observational (non-randomised) studies produce less stringent results than RCTs, being prone to unmeasured confounders and biases. On the other hand, these study designs may represent in the "real world" the only practical option to obtain risk estimates once a new drug has entered the market.

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