Clinical Research Center
NYU Long Island School of Medicine’s Clinical Research Center, formerly the Clinical Trial Center, was established in 2001 to expand our clinical trial presence by providing comprehensive clinical research support to investigators.
In our first decade, we have met with success in the following spheres:
- attracting investigators into clinical trials
- initiating trials in a large number of disciplines
- developing a functional clinical trials unit incorporating regulatory, coordinator, laboratory, and pharmacy services
- attracting a wide variety of pharmaceutical corporate sponsors
- gaining recognition for NYU Long Island School of Medicine’s clinical research ventures
Our faculty members, many of whom have achieved national and international recognition as clinical experts in their respective therapeutic areas, participate in a broad range of studies. The Clinical Research Center offers researchers a centralized location where they have easy access to the resources they need to participate in clinical trials in accordance with government and industry standards. Our center is central to the mission of NYU Langone Hospital—Long Island: to provide high-quality, culturally competent, and comprehensive healthcare services in a teaching and research environment that improves the health and wellbeing of the residents of our community.
The Clinical Research Center provides eight examination rooms, including two that are set up for extended research visits with beds and observation stations; a research pharmacy; an on-site laboratory equipped for specimen processing and storage; and office space for staff and investigators. The center is fully staffed with experienced certified clinical research coordinators, laboratory personnel, research pharmacists, and regulatory and finance staff. All personnel conducting clinical trials are trained in U.S. Food and Drug Administration (FDA) guidelines, good clinical practice, and internal standard operating procedures that govern the investigation of test articles before working on a research project.
Key Therapeutic Areas of Collaboration
We actively collaborate with investigators in the following key therapeutic areas.
Investigators from the Division of Pulmonary, Critical Care, and Sleep Medicine in the Department of Medicine under the direction of Shilpa A. DeSouza, MD, have been active participants in clinical trials of investigative agents for the treatment of idiopathic pulmonary hypertension. Supported by the medical intensive care unit team and the catheterization laboratory, our center has most recently participated in studies of selexipag, riociguat, treprostinil, and macitentan.
Rheumatology and Autoimmune Disease
The Division of Rheumatology and Allergy is at the forefront of clinical research in Sjogren’s syndrome, an autoimmune disorder affecting the exocrine glands as well as other body systems. Supported by the division’s Sjogren’s syndrome cohort database, the group, led by Steven E. Carsons, MD, is currently recruiting participants to study a new injectable biologic treatment for Sjogren’s syndrome. In addition, our center is conducting studies in rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, and gouty arthritis.
Allergic Disease and Asthma
The Section of Allergy in the Division of Rheumatology and Allergy conducts studies of new therapeutic agents for asthma. Under the direction of Luz S. Fonacier, MD, the section has participated in the investigation of new anti-inflammatory agents administered by inhaler and has a particular interest in investigating new biologic agents directed at cytokines implicated in asthma. The group is also participating in studies of biologics for the treatment of chronic urticaria (hives). Mark Davis-Lorton, MD, is a leading clinical investigator in the area of hereditary angioedema.
In collaboration with the Comprehensive Multiple Sclerosis Center in the Department of Neurology, the Clinical Research Center has a long history of participation in clinical trials of therapeutic agents including new biologic therapies for multiple sclerosis (MS). An upcoming clinical trial focuses on primary progressive MS.
Diabetes and Endocrinology
Adult and pediatric endocrinology and metabolism specialists are active in clinical trials in multiple therapeutic areas related to endocrinology. In addition to studies in diabetes mellitus, the Clinical Research Center participates in studies related to growth hormone deficiency in children. In conjunction with physicians from the Division of Pediatric Endocrinology, our center has been involved in multiple studies of Prader-Willi syndrome, a rare genetic disorder that results in childhood obesity.
Our center is also closely aligned and integrated with research programs across NYU Langone.
In 2020, NYU Langone’s Vaccine Center, under the direction of Mark J. Mulligan, MD, was established as a Vaccine and Treatment Evaluation Unit (VTEU) by the National Institute of Allergy and Infectious Diseases (NIAID). Ours is 1 of 10 such units nationwide that conduct clinical trials of vaccines and treatments for infectious diseases. The Clinical Research Center is home to the Long Island site of the VTEU. The Vaccine Center’s site at NYU Langone Hospital—Long Island is among those conducting phase 2/3 trials of the AstraZeneca candidate COVID-19 vaccine. The National Institutes of Health (NIH) COVID-19 Protection Network (CoVPN) funds the study.
The VTEU site on Long Island will conduct further studies of additional vaccine candidates for COVID-19, as well as for other emerging infectious diseases.
Center for Biospecimen Research and Development
NYU Langone’s Center for Biospecimen Research and Development (CBRD) focuses on increasing clinical trial support for investigator-initiated trials and improving researcher access to biospecimen resources. A satellite CBRD for biobank specimen processing and storage is located in close proximity to the Clinical Research Center, and serves as a resource for our investigators.
Perlmutter Cancer Center
The Clinical Research Center provides regulatory support for Perlmutter Cancer Center at NYU Langone Hospital—Long Island and collaborates in the performance of cancer clinical trials for the Long Island region.
Clinical and Translational Science Institute
Our center has an ongoing collaboration with NYU Langone’s Clinical and Translational Science Institute (CTSI) and is available to recruit and enroll participants for CTSI studies.
If you have questions or would like additional information about the Clinical Research Center, please contact us at firstname.lastname@example.org. You can also reach out to our staff members.
Kimberly Byrnes, CCRC
Steven E. Carsons, MD
Division Chief, Clinical and Translational Medicine