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Proposal for a “phase II ” multicenter trial model for preclinical new antiepilepsy therapy development
Author(s) -
O'Brien Terence J.,
BenMenachem Elinor,
Bertram Edward H.,
Collins Stephen D.,
Kokaia Merab,
Lerche Holger,
Klitgaard Henrik,
Staley Kevin J.,
Vaudano Elisabetta,
Walker Matthew C.,
Simonato Michele
Publication year - 2013
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/epi.12300
Subject(s) - clinical trial , medicine , drug development , epilepsy , intensive care medicine , preclinical testing , preclinical research , phases of clinical research , drug , pharmacology , medical physics , psychiatry
Summary There is a pressing need to address the current major gaps in epilepsy treatment, in particular drug‐resistant epilepsy, antiepileptogenic therapies, and comorbidities. A major concern in the development of new therapies is that current preclinical testing is not sufficiently predictive for clinical efficacy. Methodologic limitations of current preclinical paradigms may partly account for this discrepancy. Here we propose and discuss a strategy for implementing a “phase II ” multicenter preclinical drug trial model based on clinical phase II / III studies designed to generate more rigorous preclinical data for efficacy. The goal is to improve the evidence resulting from preclinical studies for investigational new drugs that have shown strong promise in initial preclinical “phase I” studies. This should reduce the risk for expensive clinical studies in epilepsy and therefore increase the appeal for funders (industry and government) to invest in their clinical development.