A MULTICENTER, LONGITUDINAL, INTERVENTIONAL, DOUBLE BLIND RANDOMIZED CLINICAL TRIAL IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS RESIDING IN REMOTE AREAS: LESSONS LEARNED FROM THE LATE CYTOMEGALOVIRUS PREVENTION TRIAL.

Journal: Contemporary clinical trials communications
Published Date: May 5, 2016

Abstract

PURPOSE: The logistics of conducting double-blinded phase III clinical trials with participants residing in remote locations are complex. Here we describe the implementation of an interventional trial for the prevention of late cytomegalovirus (CMV) disease in hematopoietic cell transplantation (HCT) subjects in a long-term follow-up environment.

Authors

  • Louise E Kimball
    Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Terry Stevens-Ayers
    Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Margaret L Green
    Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington; Medicine, University of Washington, Seattle, Washington.
  • Hu Xie
    Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Mary E D Flowers
    Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington; Medicine, University of Washington, Seattle, Washington.
  • Keith R Jerome
    Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington; Virology Division, University of Washington, Seattle, Washington; Department of Laboratory Medicine, University of Washington, Seattle, Washington.
  • Renee LeBlanc
    Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • Christi Dahlgren
    Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington.
  • W Garrett Nichols
    Chimerix Inc., Durham, NC.
  • Roy F Chemaly
    Department of Infectious Diseases, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • G Papanicolaou
    Infectious Disease Service, Memorial Sloan Kettering Cancer Center, New York, NY.
  • Michael Boeckh
    Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington; Clinical Research Divisions, Fred Hutchinson Cancer Research Center, Seattle, Washington; Medicine, University of Washington, Seattle, Washington.

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