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Pre-Clinical Testing of Therapies for Traumatic Brain Injury.

Publication ,  Journal Article
DeWitt, DS; Hawkins, BE; Dixon, CE; Kochanek, PM; Armstead, W; Bass, CR; Bramlett, HM; Buki, A; Dietrich, WD; Ferguson, AR; Hall, ED; Long, JB ...
Published in: Journal of neurotrauma
December 2018

Despite the large number of promising neuroprotective agents identified in experimental traumatic brain injury (TBI) studies, none has yet shown meaningful improvements in long-term outcome in clinical trials. To develop recommendations and guidelines for pre-clinical testing of pharmacological or biological therapies for TBI, the Moody Project for Translational Traumatic Brain Injury Research hosted a symposium attended by investigators with extensive experience in pre-clinical TBI testing. The symposium participants discussed issues related to pre-clinical TBI testing including experimental models, therapy and outcome selection, study design, data analysis, and dissemination. Consensus recommendations included the creation of a manual of standard operating procedures with sufficiently detailed descriptions of modeling and outcome measurement procedures to permit replication. The importance of the selection of clinically relevant outcome variables, especially related to behavior testing, was noted. Considering the heterogeneous nature of human TBI, evidence of therapeutic efficacy in multiple, diverse (e.g., diffuse vs. focused) rodent models and a species with a gyrencephalic brain prior to clinical testing was encouraged. Basing drug doses, times, and routes of administration on pharmacokinetic and pharmacodynamic data in the test species was recommended. Symposium participants agreed that the publication of negative results would reduce costly and unnecessary duplication of unsuccessful experiments. Although some of the recommendations are more relevant to multi-center, multi-investigator collaborations, most are applicable to pre-clinical therapy testing in general. The goal of these consensus guidelines is to increase the likelihood that therapies that improve outcomes in pre-clinical studies will also improve outcomes in TBI patients.

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Published In

Journal of neurotrauma

DOI

EISSN

1557-9042

ISSN

0897-7151

Publication Date

December 2018

Volume

35

Issue

23

Start / End Page

2737 / 2754

Related Subject Headings

  • Neurology & Neurosurgery
  • Humans
  • Disease Models, Animal
  • Brain Injuries, Traumatic
  • Animals
  • 5202 Biological psychology
  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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DeWitt, D. S., Hawkins, B. E., Dixon, C. E., Kochanek, P. M., Armstead, W., Bass, C. R., … Zhang, L. (2018). Pre-Clinical Testing of Therapies for Traumatic Brain Injury. Journal of Neurotrauma, 35(23), 2737–2754. https://doi.org/10.1089/neu.2018.5778
DeWitt, Douglas S., Bridget E. Hawkins, C Edward Dixon, Patrick M. Kochanek, William Armstead, Cameron R. Bass, Helen M. Bramlett, et al. “Pre-Clinical Testing of Therapies for Traumatic Brain Injury.Journal of Neurotrauma 35, no. 23 (December 2018): 2737–54. https://doi.org/10.1089/neu.2018.5778.
DeWitt DS, Hawkins BE, Dixon CE, Kochanek PM, Armstead W, Bass CR, et al. Pre-Clinical Testing of Therapies for Traumatic Brain Injury. Journal of neurotrauma. 2018 Dec;35(23):2737–54.
DeWitt, Douglas S., et al. “Pre-Clinical Testing of Therapies for Traumatic Brain Injury.Journal of Neurotrauma, vol. 35, no. 23, Dec. 2018, pp. 2737–54. Epmc, doi:10.1089/neu.2018.5778.
DeWitt DS, Hawkins BE, Dixon CE, Kochanek PM, Armstead W, Bass CR, Bramlett HM, Buki A, Dietrich WD, Ferguson AR, Hall ED, Hayes RL, Hinds SR, LaPlaca MC, Long JB, Meaney DF, Mondello S, Noble-Haeusslein LJ, Poloyac SM, Prough DS, Robertson CS, Saatman KE, Shultz SR, Shear DA, Smith DH, Valadka AB, VandeVord P, Zhang L. Pre-Clinical Testing of Therapies for Traumatic Brain Injury. Journal of neurotrauma. 2018 Dec;35(23):2737–2754.
Journal cover image

Published In

Journal of neurotrauma

DOI

EISSN

1557-9042

ISSN

0897-7151

Publication Date

December 2018

Volume

35

Issue

23

Start / End Page

2737 / 2754

Related Subject Headings

  • Neurology & Neurosurgery
  • Humans
  • Disease Models, Animal
  • Brain Injuries, Traumatic
  • Animals
  • 5202 Biological psychology
  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences