ISSUES IN PHARMACOECONOMIC STUDIES WITH PSYCHOTROPICS - SOME PRACTICAL CONSIDERATIONS

The assessment of quality of life (QoL) and economic outcomes of psych otropic medications are closely related. Both costs and QoL are import ant in establishing the value of new and existing drugs in order to as sist patients, physicians, payers of health care, and society to make optimal decisions. These parameters may be combined, as in cost-utilit y analyses, or analysed separately. Although not a true reflection of normal practice, clinical trials are most often the setting for measur ement of these parameters. The viability of such analyses, which often necessitate the inclusion of active comparators and additional work m easuring costs and QoL, within the context of controlled studies must be established early on in the development process. If 'registration o riented' trials are inappropriate, alternative strategies must be purs ued.