Data from regulatory studies: What do they tell? What don't they tell?

Ben-Menachem, Elinor,1945Gothenburg University,Göteborgs universitet,Institutionen för klinisk neurovetenskap, Sektionen för kliniska nervsjukdomar,Institute of Clinical Neurosciences, Section of Neurological Diseases (author)

Phase III studies of antiepileptic drugs (AEDs) are specifically designed to satisfy strict regulatory criteria. As they are conducted in protocol-restricted patient populations over short treatment periods and employ fixed study designs and dosing schedules, they are not fully representative of 'real-life' clinical practice. Therefore, in order to provide an overall assessment of clinical performance, regulatory studies must be backed up by post-marketing clinical experience. Phase IV studies provide information on a drug's performance in a setting more closely representing real clinical practice, with broader patient populations and a more flexible approach to individual treatment. Prospective long-term studies allow the determination of efficacy and safety (and cost-effectiveness) over extended treatment periods; these studies and audit data provide a means of assessing idiosyncratic side effects, unusual interactions and the effects of an AED in rare patient groups. By complementing regulatory evidence with real-life clinical experience, a comprehensive assessment of the risks and benefits of an AED can be made.

Göteborgs universitetInstitutionen för klinisk neurovetenskap, Sektionen för kliniska nervsjukdomar (creator_code:org_t)

In:Acta neurologica Scandinavica. Supplementum: Hindawi Limited181, s. 21-50065-14270001-63141600-0404

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