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Clinical Trials Center

The Clinical Trial Center (CTC) was established in 2001 in order to expand NYU Winthrop's Clinical Trial presence by providing comprehensive clinical research support to investigators.

In its first decade the CTC, has met with success in the following spheres: 1) attracting investigators into clinical trials; 2) initiating trials in a wide number of disciplines; 3) developing a functional clinical trials unit incorporating regulatory, coordinator, laboratory and pharmacy services; 4) attracting a wide variety of pharmaceutical corporate sponsors; and 5) gaining recognition for NYU Winthrop's clinical research ventures.

Our faculty members, many of whom have achieved national and international recognition as clinical experts in a broad range of therapeutic areas, participate in a broad range of studies. To assist them we provide a wide range of services that begin before a trial starts and continue after the project ends. Available services include assistance with protocol development, feasibility assessment, contract review, budget negotiations, study accounting, regulatory submissions, clinical trial management, recruitment, study coordination and data manager support.

A centralized location provides easy access to resources for investigators to participate in clinical trials in accordance with government and industry standards. Examination rooms, research pharmacy, laboratory, most required medical equipment, CRF storage, high-speed wired and wireless internet access, and monitoring rooms are readily available for clinical trial operations. The Center, conveniently located in central Nassau County, adjacent to the Mineola LIRR station, is fully staffed with experienced certified clinical research coordinators, laboratory personnel, research pharmacists, and ancillary staff. All personnel conducting clinical trials are required to have been trained in FDA guidelines, good clinical practice as well as internal standard operating procedures that govern the investigation of test articles prior to working on a research project.

Increasingly, government and private companies are recognizing that for research to be generalizeable, it must be inclusive. Participating in a trial with NYU Winthrop Hospital guarantees that result. NYU Winthrop Hospital is committed to quality in health care delivery, the creation of a broader health care delivery system, the promotion of health and health related education, as well as furthering the economic development of the Long Island community we serve. It is the mission of NYU Winthrop Hospital to provide high quality, culturally competent, and comprehensive health care services in a teaching and research environment which improve the health and well-being of the residents of Nassau County and contiguous areas."

The CTC utilizes the AAHRPP accredited NYU Winthrop Hospital IRB for both in and outpatient Phase 1 & 2 trials and Western IRB (WIRB) for Phase 3 & 4 clinical trials.

NYU Winthrop Hospital affiliations include the Stony Brook School of Medicine, Columbia University's Herbert Irving Comprehensive Cancer Center and the Long Island Health Network.

CTC Investigators

Siham Accacha, M.D.
Nicholas Berbari, MD
Steven Carsons, M.D.
Martin Chavez, MD
Shalinee Chawla, MD
Mark Davis-Lorton, MD
Luz Fonacier, MD
Malcolm Gottesman, MD
James Grendell, MD
Bhawna Halwan, MD
Jonathan Ilowite, M.D.
Wendy Kinzler, MD
Natalie Klein, MD
Michael Niederman, M.D.
Orlando Ortiz, M.D.
Michael Radin, MD
Gary Rosenblum, MD
Anuja Shah, MD
Larwrence Shapiro, M.D.
Peter Spiegler, MD
Albert Tse, MD
Michael Weinstein, M.D.
Elzbieta Wirkowski, MD

Available Services

  1. Protocol Review & Feasibility Assessment
  2. Regulatory preparation
    1. IRB Submission
    2. IRB Continuing Review
    3. Budget preparation and review
    4. Medicare Coverage Analysis
    5. Financial Management
  3. Study Coordination
    1. Data Management
    2. Recruitment
    3. Laboratory & IP Management
    4. Sample Preparation
  4. Research Education
    1. Introduction to Research Coordination
    2. Good Clinical Practice (GCP)
    3. Monthly In-Service Updates