Clinical trial design in the neurocritical care unit

C. E. Hall, M. Mirski, Y. Y. Palesch, M. N. Diringer, A. I. Qureshi, C. S. Robertson, R. Geocadin, C. A.C. Wijman, P. D. Le Roux, Jose I. Suarez

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations

Abstract

Clinical trials provide a robust mechanism to advance science and change clinical practice across the widest possible spectrum. Fundamental in the Neurocritical Care Society's mission is to promote Quality Patient Care by identifying and implementing best medical practices for acute neurological disorders that are consistent with the current scientific knowledge. The next logical step will be to foster rapid growth of our scientific body of evidence, to establish and disseminate these best practices. In this manuscript, five invited experts were impaneled to address questions, identified by the conference organizing committee as fundamental issues for the design of clinical trials in the neurological intensive care unit setting.

Original languageEnglish (US)
Pages (from-to)6-19
Number of pages14
JournalNeurocritical Care
Volume16
Issue number1
DOIs
StatePublished - Feb 2012

Bibliographical note

Funding Information:
Given that, large phase III clinical trials may provide the necessary tipping point required to change clinical practice, but the question that follows is, how best are major clinical trials supported, by industry or federal agencies? Large resource intensive phase III clinical trials may require complex funding strategies. The ISAT trial [36] for instance received support from multiple sponsor sources including grants from: (1) The medical research council, UK; (2) Programme Hospitalier de Recherche Clinique 1998 of the French ministry of health (AOM 98150); (3) Assistance Publique, Hopitaux de Paris (AP-HP); (4) The Canadian institutes of health research; and (5) The Stroke Association of the UK. Additionally, investigators had industry consulting and advisory agreements as well as stock interest with Microtherapeutics Inc. and Micrus Inc., which are manufacturers of microcatheters and detachable platinum coils.

Funding Information:
P01 Research Program Project Grant

Keywords

  • Funding
  • Industry
  • NIH
  • Neurocritical care
  • Surrogate markers

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