Evaluation of treatment risks: taking clinical data, pharmacology and patient characteristics into account.
The risks of a given treatment to an individual patient are assessed on the basis of evidence from evaluations of the treatment, pharmacological arguments and consideration of certain patient-specific characteristics. Knowledge of the adverse effects of a treatment, based on data from trials, studies and pharmacovigilance, contributes to the evaluation of the risks to which patients are exposed. Clinical trials are not the ideal way to study adverse effects. It is better to gather other types of information (including pharmacological and physiological data) to generate a sufficiently solid body of evidence with which to "manage uncertainty". Patient characteristics must be taken into account to determine whether they constitute risk factors for the adverse effects of treatment. Patients should be informed about the potential risks as well as the anticipated benefits of a treatment, so that they have the means to actively participate in assessing the risk-benefit balance of their own treatment.
D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D018570:Risk Assessment