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Clinical Trial Design in the Neurocritical Care Unit

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.

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Acknowledgements

The First Neurocritical Care Research Conference was funded by award R13NS065494 from the National Institute of Neurological Disorders and Stroke (P.I.: JI Suarez), the Integra Foundation, and the Neuroscience Center of the St Luke’s Episcopal Hospital in Houston, TX, and endorsed by the Neurocritical Care Society.

Disclosures

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.

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Corresponding author

Correspondence to Jose I. Suarez.

Additional information

This study is conducted for the First Neurocritical Care Research Conference Investigators.

The list of investigators who participated in this study are given in Appendix

Appendix

Appendix

The first neurocritical care research conference investigators are as follows:

Organizing Committee

Chair: Suarez JI, MD, Baylor College of Medicine, Houston, TX; Calvillo E, RN, Baylor College of Medicine, Houston, TX; Geocadin R, MD, Johns Hopkins University, Baltimore, MD; Hall C, MD, UT Southwestern University; Le Roux PD, MD, University of Pennsylvania, Philadelphia, PA; Livesay S, MS, RN, ACNP, St Luke’s Episcopal Hospital, Houston, TX; Mayer SA, MD, Columbia University, New York, NY; Vespa P, MD, UCLA, Los Angeles, CA; Wijman C, MD, Stanford University, Palo Alto, CA; Zaidat OO, MD, MS, Medical College of Wisconsin, Milwaukee, WI.

Speakers

Bleck TP, RUSH School of Medicine, Chicago, IL; Chang C, MD, University of Hawaii, John A. Burns School of Medicine, Honolulu, HI; Cooper DJ, MD, Alfred Hospital and Monash University, Melbourne, Australia; Guntupalli KK, MD, Baylor College of Medicine, Houston, TX; Daily J, PhD, Case Western Reserve University, Cleveland, OH; Diringer MA, MD, Washington University School of Medicine, St Louis, MO; Robertson CS, MD, Baylor College of Medicine, Houston, TX; Hanley DF, MD, Johns Hopkins University, Baltimore, MD; Hemphill C III, MD, PhD, University of California in San Francisco, San Francisco, CA; Koroshetz W, MD, Deputy Director, NINDS, Bethesda. MD; Mirski MA, MD, PhD, Johns Hopkins University, Baltimore, MD; Palesch Y, PhD, Medical University of South Carolina; Qureshi AI, MD, University of Minnesota, Minneapolis, MN; Silbergleit R, MD, University of Michigan, Ann Arbor, MI; Smirnakis SM, MD, PhD, Baylor College of Medicine, Houston, TX; Szigeti K, MD, PhD, Baylor College of Medicine, Houston, TX.

Attendees

Adeoye O, MD, University of Cincinnati College of Medicine, Cincinnati, OH; Aisiku IP, University of Texas in Houston, Houston, TX; Bader MK, RN, Mission Viejo Hospital, Mission Viejo, CA; Ansari S, MD, Baylor College of Medicine, Houston, TX; Arshad ST, MD, Baylor College of Medicine, Houston, TX; Badjatia N, MD, Columbia University, New York, NY; Barazangi N, MD, Ph.D., Califorrnia Pacific Medical Center, San Francisco, CA; Bershad EM, MD, Baylor College of Medicine, Houston, TX; Boyd C, RN, MBA, St Luke’s Episcopal Hospital, Houston, TX; Claassen J, MD, Columbia University, New York, NY; Coplin W, MD, Wayne State University, Detroit, MI; Corry JJ, Henry Ford Hospital, Detroit, MI; Cruz-Florez S, MD, St Louis University, St Louis, MO; Dhar R, MD, Washington University School of Medicine, St Louis, MO; Dillon C, MS, Medical University of South Carolina, Charleston, SC; Divani AA, Ph.D., University of Minnesota, Minneapolis, MN; Duckworth E, MD, Baylor College of Medicine, Houston, TX; Ezzedine M, MD, University of Minnesota, Minneapolis, MN; Feen E, MD, St Louis University, St Louis, MO; Freeman W, MD, Mayo Clinic Florida, Jacksonville, FL; Frontera J, MD, Mount Sinai School of Medicine, New York, NY; Goodman JC, MD, Baylor College of Medicine, Houston, TX; Graffagnino C, MD, Duke University, Durham, NC; Hoesch RE, MD, PhD, Johns Hopkins University, Baltimore, MD; Ko NU, MD, University of California in San Francisco, San Francisco, CA; Koening M, MD, Johns Hopkins University, Baltimore, MD; Kramer A, University of Calgary, Calgary, AL, Canada; Lazaridis C, MD, Medical University of South Carolina, Charleston, SC; Lee JC, MD, Baylor College of Medicine, Houston, TX; Ling G, MD, PhD, US Armed Forces, Bethesda, MD; Macdonald RL, MD, Ph.D., University of Toronto, Toronto, ON, Canada; Malkoff M, MD, University of New Mexico, Albuquerque, NM; Mandava P, MD, Baylor College of Medicine, Houston, TX; Manno E, MD, Mayo Clinic, Rochester, MN; Martin H Renee, Ph.D., Medical University of South Carolina, Charleston, SC; Mawad M, MD, Baylor College of Medicine, Houston, TX; Mizrahi E, MD, Baylor College of Medicine, Houston, TX; McArthur DL, Ph.D., UCLA, Los Angeles, CA; Nathan B, MD, University of Virginia, Charlottesville, VA; Newmark M, MD, Baylor College of Medicine, Houston, TX; Nguyen T, PharmD, St Luke’s Episcopal Hospital, Houston, TX; Nyquist P, MD, Ph.D., The Johns Hopkins Hospital, Baltimore, MD; Oliveira J, Hospital San Rafael, Universidade Federale da Bahia, Salvador, Brazil; Olson DW, RN, PhD, Duke University, Durham, NC; Ougorets I, MD, New York Weil Medical College of Cornell University, New York, NY; Puppo C, MD, Universidad de la República, Montevideo, Uruguay; Pyne-Geithman G, Ph.D., University of Cincinnati, Cincinnati, OH; Rao CPV, Baylor College of Medicine, Houston, TX; Revuelto J, MD, Hospital Virgen del Rocio, Seville, Spain Rhoney D, PharmD, Detroit Receiving Hospital, Detroit, MI; Riviello J, MD, Baylor College of Medicine, Houston, TX; Sawaya R, MD, Baylor College of Medicine, Houston, TX; Seder D,MD, Maine Medical Center, Portland, ME; Sheth K, MD, Brigham and Women’s Hospital, Boston, MA; Souter M, MD, University of Washington, Seattle, WA; Strutt AM, Ph.D., Baylor College of Medicine, Houston, TX; Suri MFK, MD, University of Minnesota, Minneapolis, MN; Temes R, MD, RUSH Medical Center, Chicago, IL; Torbey MT, MD, MPH, Medical College of Wisconsin, Milwaukee, WI; Treggiari M, University of Washington, Seattle, WA; Urfy MZ, MD, Baylor College of Medicine, Houston, TX Varelas P, MD, Ph.D., Henry Ford Hospital, Detroit, MI; Wright W, MD, Emory University, Atlanta, GA; York MK, Ph.D., Baylor College of Medicine, Houston, TX; Ziai W, MD, Johns Hopkins University, Baltimore, MD; Zwillman M, MD, The Methodist Hospital, Houston, TX.

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Hall, C.E., Mirski, M., Palesch, Y.Y. et al. Clinical Trial Design in the Neurocritical Care Unit. Neurocrit Care 16, 6–19 (2012). https://doi.org/10.1007/s12028-011-9608-6

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Keywords

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