Clinical Research Experience
The Rogosin Institute has been involved in clinical research for over 40 years and is a pioneer in the treatment of Chronic Renal Insufficiency, End Stage Renal Disease, Transplantation, Polycystic Kidney Disease, Sepsis and Lipid (cholesterol) Disorders, Cancer and Diabetes.

The Institute conducts Phase I, II, III, and IV studies in the therapeutic areas of kidney disease, hemodialysis, peritoneal dialysis, transplantation, hypertension, lipids (cholesterol), polycystic kidney disease and coronary artery disease (secondary to cholesterol and lipid disorders.).

The Institute has been involved as a clinical research site in the developmental process of many commercially available medications for the treatment of cholesterol and renal disorders. The Rogosin Institute has worked and/or is currently working with over twenty pharmaceutical companies and over ten contract research organizations.

In addition to involvement in the clinical drug trials, RI was directly involved in the development of LDL-apheresis, an extracoporeal treatment for patients with severe hypercholesterolemia. The treatment device, Liposorber LA-15, is now available throughout the US and Europe.

The Institute also developed a lipid emulsion, still in the investigational stage, which may be a potential treatment/prevention for endotoxemia. The Institute was responsible for the Phase I, first time in man studies using this emulsion.

Facility Description
Renal studies are conducted at our facilities in Manhattan, Queens and Brooklyn.

Therapeutic trials areas include:
• Chronic Renal Insufficiency involving subjects who are pre-dialysis
• End Stage Renal Disease (ESRD) involving subjects who are on hemodialysis, peritoneal dialysis or nocturnal hemodialysis.
• Polycystic Kidney Disease
• Hypertension; primary and secondary (to renal disease)
• Transplantation (Kidney and Kidney/Pancreas)

Lipid studies are conducted at our Comprehensive Lipid Control Center located in Manhattan.

Therapeutic trial areas include:
• Hypercholesterolemia
• Hypertriglyceridemia
• Syndrome X
• Low HDL

Investigator Experience
Bruce R. Gordon, M.D. Title: Director, Clinical Research Program Area of Expertise: Lipid and Atherosclerosis

Dr. Gordon is responsible for the overall coordination of the Clinical Research Program.

Dr. Gordon is a Professor of Clinical Medicine and Surgery at Weill Medical College of Cornell University and an Attending Physician at New York Presbyterian Hospital/Cornell. He is the Co-Director of the Comprehensive Lipid Control Center and his research focuses primarily on lipids and cardiovascular research at the Comprehensive Lipid Control Center.

Dr. Gordon has over 22 years experience in clinical research and has been Principal Investigator for over 20 clinical trials.

Betty-Jane Sloan, BS, MA, CCRC
Title: Clinical Research Manager

Ms. Sloan has more than twelve years experience in clinical research at The Rogosin Institute's Comprehensive Lipid Control Center and is the Research Manager for the RI Clinical Research Program.

She was certified in 1995 as a clinical research coordinator through the Association of Clinical Research Professionals and is a Staff Associate in the Department of Medicine at Weill Medical College of Cornell University.

Reserach and Support Staff
The Rogosin Institute offers five full time clinical research coordinators and two part time clinical research assistants. All of our coordinators have more than two years experience in clinical research.

Institute Physicians
The majority of physicians at The Institute have experience as a Principle Investigator and all are experienced research investigators in both sponsored or investigator initiated clinical trials.

Investigator Training
All investigators and coordinators at the Institute complete formal training in the protection of human subjects in research. Physicians are required to complete the manual "Protecting Human Subjects in Research" and supporting research staff complete the online NIH website training module "Protection of Human Research Subjects."

Other Information
Institutional Review Boards
The Rogosin Institute can conduct clinical research studies using either central (commercial) Institutional Review Boards (IRB) or the local IRB of the Weill Medical College or Rockefeller University.

General Clinical Research Centers (GCRC)
The Rogosin Institute has access to both New York Presbyterian Hospital/Cornell and Rockefeller University's Clinical Research Centers for inpatient studies.

Clinical and Reseerach Laboratories
The Rogosin Institute has Clinical and Research Laboratories that are located on the campus of The Rockefeller University in Manhattan. Of particular interest to our laboratory is the development of cytokine assays for both research and clinical purposes.

Information Technology
The Institute employees a fulltime Database Systems Manager to provide our investigators with data management for investigator initiated studies.

MIQS Disease Manager Plus ™, a computerized informational network system, is utilized at The Rogosin Institute. MIQS provides enhancement of record keeping as well as immediate access to information on a patient's history, treatment and laboratory data at all Rogosin Institute facilities and New York Presbyterian Hospital/Cornell.

Links
To view current studies open for enrollment, please visit us on the CenterWatch web site at http://centerwatch.com/professional/pro400.html#8.

Contact Information
If you would like more information regarding the Clinical Research Program at The Rogosin Institute, please contact:

Betty-Jane Sloan, CCRC, Clinical Research Manager
1167 York Avenue
New York, NY 10021 USA
Phone: 212-702-9600 Ext. 22
Fax: 212-702-9588
E-mail: riclin@mail.rockefeller.edu