How clinically useful are regulatory trials with new antiepileptic drugs?

Much time, money and effort on behalf of patients, doctors, statisticians, pharmaceutical personnel and regulators are spent in planning and undertaking clinical trial programmes that result in antiepileptic drugs reaching the marketplace and thereafter becoming available for treating people with epilepsy in everyday clinical practice. Rather unusually, both the American and European Authorities require separate trial programmes to licence each drug for their adjunctive and monotherapy use. These studies also often contribute to clinical guideline development. This short paper discusses the design of these trials and their clinical value to the clinician.