Proposal for a “phase II ” multicenter trial model for preclinical new antiepilepsy therapy development
Year: 2013
Type: article
Abstract: 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.
Source: Epilepsia
DOI: 10.1111/epi.12300
Institutions: The Royal Melbourne Hospital, The University of Melbourne, University of Virginia Health System, Lund University, Hertie Institute for Clinical Brain Research, UCB Pharma (Belgium), Harvard University, Massachusetts General Hospital, Innovative Medicines Initiative, UCL Queen Square Institute of Neurology, University College London, University of Ferrara
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Autism Speaks, Citizens United for Research in Epilepsy, European Commission, Bundesministerium für Bildung und Forschung, University College London Hospitals NHS Foundation Trust, Epilepsy Society, Medical Research Council, National Health and Medical Research Council, UCLH Biomedical Research Centre, UCB Pharma
OpenAlex ID: W2073760808