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Proposal for a "phase II" multicenter trial model for preclinical new antiepilepsy therapy development

O'Brien, Terence J.; Ben-Menachem, Elinor; Bertram, Edward H. III; Collins, Stephen D.; Kokaia, Merab LU ; Lerche, Holger; Klitgaard, Henrik; Staley, Kevin J.; Vaudano, Elisabetta and Walker, Matthew C., et al. (2013) In Epilepsia 54. p.70-74
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... (More)
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. (Less)
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type
Contribution to journal
publication status
published
subject
keywords
Preclinical development, Antiepilepsy therapies, Multicenter
in
Epilepsia
volume
54
pages
70 - 74
publisher
Wiley-Blackwell
external identifiers
  • wos:000322584900008
  • scopus:84891714244
ISSN
0013-9580
DOI
10.1111/epi.12300
language
English
LU publication?
yes
id
cced1550-b9f8-4c6d-896c-332383d37546 (old id 4042757)
date added to LUP
2013-10-01 15:17:13
date last changed
2019-02-27 01:59:23
@article{cced1550-b9f8-4c6d-896c-332383d37546,
  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.},
  author       = {O'Brien, Terence J. and Ben-Menachem, Elinor and Bertram, Edward H. III and Collins, Stephen D. and Kokaia, Merab and Lerche, Holger and Klitgaard, Henrik and Staley, Kevin J. and Vaudano, Elisabetta and Walker, Matthew C. and Simonato, Michele},
  issn         = {0013-9580},
  keyword      = {Preclinical development,Antiepilepsy therapies,Multicenter},
  language     = {eng},
  pages        = {70--74},
  publisher    = {Wiley-Blackwell},
  series       = {Epilepsia},
  title        = {Proposal for a "phase II" multicenter trial model for preclinical new antiepilepsy therapy development},
  url          = {http://dx.doi.org/10.1111/epi.12300},
  volume       = {54},
  year         = {2013},
}