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Prototype Antiepileptic Drug Clinical Development Plan
Author(s) -
Kramer Lynn D.,
Pledger Gordon W.,
Kamin Marc
Publication year - 1993
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1157.1993.tb02136.x
Subject(s) - clinical trial , drug development , antiepileptic drug , food and drug administration , intensive care medicine , medicine , regimen , clinical study design , drug , clinical research , plan (archaeology) , epilepsy , risk analysis (engineering) , medical physics , pharmacology , surgery , psychiatry , archaeology , history
Summary: Antiepileptic drug (AED) development has been generally difficult owing to many factors: regulatory requirements for demonstration of efficacy and safety, subject availability, traditional trial designs, and physicians' beliefs about epilepsy and its treatment. The U.S. Food and Drug Administration (FDA) regulations require a new drug to be shown safe and effective for its intended use before it can be marketed. The unambiguous proof required is a formidable hurdle for AED development. We report a recent clinical development plan highlighting innovations in clinical trial design that have addressed these requirements, discuss alternative endpoints, and compare the results of various trial designs at various stages of development. This model clinical development plan includes trials relevant to all three clinically relevant contexts in which an AED might be used: as an adjunct to an existing regimen, as a substitution for much of an existing AED regimen, and as monotherapy.