Lessons from Adult Stroke Trials

Steven G. Pavlakis, Ralph Sacco, Steven R. Levine, James F Meschia, Yuko Palesch, Barbara C. Tilley, Harold P. Adams

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Before designing epidemiologic, genetic, or treatment trials in pediatric stroke, we should learn from adult trials which preceded. Adult trialists state that there is a need for improved animal models to mimic human disease. Dose-response curves with blinded outcome measures would improve preclinical data. Functional and histologic outcome measures would improve the animal model. In regard to human Phase 2 medication trials, safety, delivery, end points, and surrogate markers are necessary. The detection of biologic activity can be defined in Phase 2B trials. For Phase 3 trials, the experiment needs to be simple with global outcome measures as end points. New statistical designs such as futility analysis may improve and streamline trials in both adults and children. Clinical trials are a long process, and care needs to be incorporated at every step. Why is there a propensity of failed studies for acute ischemic stroke in adults? The reasons include (a) the animal model fails us, (b) the Phase 2 trials are ineffective in defining dose, and (c) the Phase 3 trials are poorly done. Because clinical trials, more often than not, fail to give positive (effective treatment) results, it seems reasonable to attempt to learn from others' past experiences before initiating pediatric stroke trials.

Original languageEnglish (US)
Pages (from-to)446-449
Number of pages4
JournalPediatric Neurology
Volume34
Issue number6
DOIs
StatePublished - Jun 2006

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Animal Models
Stroke
Outcome Assessment (Health Care)
Clinical Trials
Pediatrics
Medical Futility
Biomarkers
Safety
Therapeutics

ASJC Scopus subject areas

  • Clinical Neurology
  • Pediatrics, Perinatology, and Child Health
  • Developmental Neuroscience
  • Neurology

Cite this

Pavlakis, S. G., Sacco, R., Levine, S. R., Meschia, J. F., Palesch, Y., Tilley, B. C., & Adams, H. P. (2006). Lessons from Adult Stroke Trials. Pediatric Neurology, 34(6), 446-449. https://doi.org/10.1016/j.pediatrneurol.2005.09.010

Lessons from Adult Stroke Trials. / Pavlakis, Steven G.; Sacco, Ralph; Levine, Steven R.; Meschia, James F; Palesch, Yuko; Tilley, Barbara C.; Adams, Harold P.

In: Pediatric Neurology, Vol. 34, No. 6, 06.2006, p. 446-449.

Research output: Contribution to journalArticle

Pavlakis, SG, Sacco, R, Levine, SR, Meschia, JF, Palesch, Y, Tilley, BC & Adams, HP 2006, 'Lessons from Adult Stroke Trials', Pediatric Neurology, vol. 34, no. 6, pp. 446-449. https://doi.org/10.1016/j.pediatrneurol.2005.09.010
Pavlakis SG, Sacco R, Levine SR, Meschia JF, Palesch Y, Tilley BC et al. Lessons from Adult Stroke Trials. Pediatric Neurology. 2006 Jun;34(6):446-449. https://doi.org/10.1016/j.pediatrneurol.2005.09.010
Pavlakis, Steven G. ; Sacco, Ralph ; Levine, Steven R. ; Meschia, James F ; Palesch, Yuko ; Tilley, Barbara C. ; Adams, Harold P. / Lessons from Adult Stroke Trials. In: Pediatric Neurology. 2006 ; Vol. 34, No. 6. pp. 446-449.
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