Core C: Clinical Sciences Core

Director:  Margaret Fischl, M.D.

Dr. Fischl, professor of medicine and director, AIDS Clinical Research Unit, brings a depth of expertise in the clinical and therapeutic aspects of HIV and established knowledge of the University and the community. She has more than 20 years of experience in directing a large multidisciplinary HIV/AIDS research program that brings together faculty across multiple departments within the University.

As the director of the unit since 1986, she has been responsible for the implementation of the program, the development of policies and procedures for the conduct of HIV/AIDS clinical trials, and identifying and prioritizing individual clinical trials and research projects.

In her role as administrative associate director, Dr. Fischl will ensure that the scientific direction of the D-CFAR is pointed at the greatest challenges in clinical HIV disease and that the D-CFAR members are in compliance with all regulatory matters related to conduct of clinical studies.

Margaret A. Fischl, M.D., F.A.C.P.
Professor of Medicine
Director, AIDS Clinical Research Unit
University of Miami School of Medicine
1800 NW 10th Avenue (R-60A)
Miami, FL 33136
Ph: 305-243-3847
Fax: 305-545-6705
email: mfischl@med.miami.edu

Subcore Leader: Kristopher Arheart, Ed.D.
Dr. Arheart is associate professor of biostatics in the Department of Epidemiology and Public Health. Dr. Arheart brings more than 20 years of experience in methodological biostatics and computer science.

Subcore Leader: Victor DeGruttola, Sc.D.
Dr. DeGruttola is a visiting scientist at the Miller School of Medicine and has been a professor of biostatistics at Harvard School of Public Health since 1996 and served as the director of the Statistics and Data Analysis Center of the A.C.T.G. from 1996 to 2003. His primary research interest is in the longitudinal modeling of markers of HIV infection, including viral load, CD4 T-lymphocyte count, and viral genotype.

The clinical support core established:

  • A biostatistics subcore dedicated to HIV/AIDS research and to closing the gap confronting investigators in this area.
    This resource is available for current NIH-funded HIV/AIDS efforts, for new investigator(s) initiatives that extend HIV/AIDS pathogenesis and translational research at UM, and for new collaborative multidisciplinary research efforts among clinical, behavioral, and basic scientists.

    Based on current needs assessments, added value will be accrued through several tangible outcomes, including new studies and resulting publications, preliminary data for new grant applications, new insights and directions in pathogenesis/translational research, and fostering new multidisciplinary collaborative studies.
  • A clinical repository and prospective longitudinal specimen bank for future pathogenesis and multidisciplinary research.
    The availability of a D-CFAR clinical repository with a matched specimen bank provides an invaluable resource for collaborative multidisciplinary pathogenesis and translational research and represents a resource to facilitate future interactions among basic, clinical, and behavioral scientists.

    Added value will be accrued through several tangible outcomes, including new insights into pathogenesis, promoting innovative pilot studies, providing preliminary data for new grant applications, fostering new multidisciplinary collaborations, and capitalizing upon existing therapeutic and preventive intervention studies, and cohort studies.
  • A safety monitoring committee and a data safety monitoring board to meet the emerging needs of human subjects research.
    Clinical studies within the established NIH therapeutic networks, such as the ACTG and the AMC, already have Data Safety Monitoring Committees and Boards. However, single center studies to be carried out at the University of Miami involving human subjects, including many behavioral interventional studies and high-risk pilot studies, require a Safety Monitoring Committee or a Data Safety Monitoring Board.  The CSC will be well positioned to provide data safety monitoring services because of the experience and expertise of the faculty associated with the CSC.