Proposal for a "phase II" multicenter trial model for preclinical new antiepilepsy therapy development
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4042757
- author
- organization
- publishing date
- 2013
- 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
- pmid:23909855
- ISSN
- 0013-9580
- DOI
- 10.1111/epi.12300
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Restorative Neurology (0131000160)
- id
- cced1550-b9f8-4c6d-896c-332383d37546 (old id 4042757)
- date added to LUP
- 2016-04-01 11:06:54
- date last changed
- 2022-04-28 07:15:29
@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}}, keywords = {{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}}, doi = {{10.1111/epi.12300}}, volume = {{54}}, year = {{2013}}, }