Clinical trials in traumatic brain injury: past experience and current developments - PubMed (original) (raw)
Review
Clinical trials in traumatic brain injury: past experience and current developments
Andrew I R Maas et al. Neurotherapeutics. 2010 Jan.
Abstract
In this article, we review past and current experience in clinical trials of traumatic brain injuries (TBIs), we discuss limitations and challenges, and we summarize current directions. The focus is on severe and moderate TBIs. A systematic literature search of the years from 1980 to 2009 revealed 27 large phase III trials in TBI; we were aware of a further 6 unpublished trials. Analysis of these 33 trials yielded interesting observations: There was a peak incidence of trial initiations that occurred in the mid-1990s with a sharp decline during the period from 2000 to 2004. Most trials that reported a significant treatment effect were studies on a therapeutic strategy (e.g., decompressive craniectomy, hypothermia), and these were single-center studies. Increasingly, studies have been shifting toward the Far East. The currently existing trial registries permit insight into ongoing or recently conducted trials. Compared with the past decade, the number of studies on neuroprotective agents taken forward into efficacy-oriented studies is low. In contrast, the number of studies on therapeutic strategies appears to be increasing again. The disappointing results in trials on neuroprotective agents in TBI have led to a critical reappraisal of clinical trial methodology. This has resulted in recommendations for preclinical workup and has triggered extensive analysis on approaches to improve the design and analysis of clinical trials in TBI. An interagency initiative toward standardization on selection and coding of data elements across the broad spectrum of TBI is ongoing, and will facilitate comparison of research findings across studies and encourage high-quality meta-analysis of individual patient data in the future.
Copyright 2010 The American Society for Experimental NeuroTherapeutics, Inc. Published by Elsevier Inc. All rights reserved.
Similar articles
- Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P. Crider K, et al. Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217. Cochrane Database Syst Rev. 2022. PMID: 36321557 Free PMC article. - The future of Cochrane Neonatal.
Soll RF, Ovelman C, McGuire W. Soll RF, et al. Early Hum Dev. 2020 Nov;150:105191. doi: 10.1016/j.earlhumdev.2020.105191. Epub 2020 Sep 12. Early Hum Dev. 2020. PMID: 33036834 - Decompressive craniectomy for the treatment of high intracranial pressure in closed traumatic brain injury.
Sahuquillo J, Dennis JA. Sahuquillo J, et al. Cochrane Database Syst Rev. 2019 Dec 31;12(12):CD003983. doi: 10.1002/14651858.CD003983.pub3. Cochrane Database Syst Rev. 2019. PMID: 31887790 Free PMC article. - A review of laboratory and clinical data supporting the safety and efficacy of cyclosporin A in traumatic brain injury.
Lulic D, Burns J, Bae EC, van Loveren H, Borlongan CV. Lulic D, et al. Neurosurgery. 2011 May;68(5):1172-85; discussion 1185-6. doi: 10.1227/NEU.0b013e31820c6cdc. Neurosurgery. 2011. PMID: 21307793 Review. - Progesterone for acute traumatic brain injury.
Ma J, Huang S, Qin S, You C, Zeng Y. Ma J, et al. Cochrane Database Syst Rev. 2016 Dec 22;12(12):CD008409. doi: 10.1002/14651858.CD008409.pub4. Cochrane Database Syst Rev. 2016. PMID: 28005271 Free PMC article. Review.
Cited by
- Practical pearls for management of cranial injury in the developing world.
Detchou D, Darko K, Barrie U. Detchou D, et al. Neurosurg Rev. 2024 Sep 10;47(1):579. doi: 10.1007/s10143-024-02822-1. Neurosurg Rev. 2024. PMID: 39251507 Review. - PPARγ activation ameliorates cognitive impairment and chronic microglial activation in the aftermath of r-mTBI.
Pearson A, Koprivica M, Eisenbaum M, Ortiz C, Browning M, Vincennie T, Tinsley C, Mullan M, Crawford F, Ojo J. Pearson A, et al. J Neuroinflammation. 2024 Aug 3;21(1):194. doi: 10.1186/s12974-024-03173-w. J Neuroinflammation. 2024. PMID: 39097742 Free PMC article. - Using machine learning to discover traumatic brain injury patient phenotypes: national concussion surveillance system Pilot.
Waltzman D, Daugherty J, Peterson A, Lumba-Brown A. Waltzman D, et al. Brain Inj. 2024 Sep 18;38(11):880-888. doi: 10.1080/02699052.2024.2352524. Epub 2024 May 9. Brain Inj. 2024. PMID: 38722037 - Mitochondria-Targeted Antioxidant Therapeutics for Traumatic Brain Injury.
Modi HR, Musyaju S, Ratcliffe M, Shear DA, Scultetus AH, Pandya JD. Modi HR, et al. Antioxidants (Basel). 2024 Feb 29;13(3):303. doi: 10.3390/antiox13030303. Antioxidants (Basel). 2024. PMID: 38539837 Free PMC article. Review. - Neuroprotection strategies in traumatic brain injury: Studying the effectiveness of different clinical approaches.
Buccilli B, Alan A, Baha' A, Shahzad A, Almealawy YF, Chisvo NS, Ennabe M, Weinand M. Buccilli B, et al. Surg Neurol Int. 2024 Jan 26;15:29. doi: 10.25259/SNI_773_2023. eCollection 2024. Surg Neurol Int. 2024. PMID: 38344087 Free PMC article. Review.
References
- Finkelstein EA, Corso PS, Miller TR, et al. The incidence and economic burden of injuries in the United States. New York: Oxford University Press; 2006.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Miscellaneous