Clinical Research

About The Clinical Research Division

The Clinical Research Division (CRD), an integral part of The Research Institute, conducts Phase I through IV investigator-initiated and multi-center clinical studies including obesity, diabetes, hypertension, lipid-lowering and other cardiovascular disorders, arthritis, cancer prevention, anti-infectives and vaccine trials. Phase II, III, and IV studies are carried out either in patient care areas or in the ambulatory care setting. 

The CRD provides research nurse specialists and research assistants who bring considerable experience to clinical research endeavors. The nurse specialist assists in moving the project through the protocol design stages to human subjects approval, recruiting and educating potential research subjects, collecting and storing data through project completion. Throughout this process, the staff assures that this work is done in an appropriate and ethical fashion.  

Bassett Healthcare is a multi-specialty collaborative medical group that makes it possible to conduct studies of any class of pharmacologic agent or that involve medical devices with specific subspecialty participation. 

The CRD exists to:

1. Support clinical research and clinical trials in various disciplines, with special interest in clinical outcomes, particularly related to obesity, diabetes and cardiovascular disease with the goal of developing  and assessing new and better treatments to improve the care of patients with these diseases.
2. Conduct research that follows the standards of Good Clinical Practice and the International Conference on Harmonization as well as following the Code of Federal Regulations for human research.
3. Promote an environment of academic excellence in research that the organization and its members may participate in and benefit from by providing a wide range of trial support services allowing our investigators to concentrate on their research.
4. Carry out research protocols for private sponsors, governmental granting agencies and professional societies and associations that is high quality and produces data that can be scrutinized without question.
5. Act as an institutional contact for sponsors facilitating identification of an investigator whose clinical trial interests, experience and patients match a sponsor's study requirements.

What is a phase I, II, III or IV study?

As a drug is developed, it goes through phases of development from pre-clinical development to initial studies with healthy volunteers to see what doses are tolerated, to what happens when a human with the condition you hope to treat takes the drug. As studies progress from phase one to four, the work becomes more specialized. Phase I, II and III studies are typically conducted before a medication has received FDA approval, though some phase III drug studies involve medications that have received approval.

Phase I studies typically involve healthy volunteers; Phase II targets people with the condition you hope to study and tests various dose ranges; Phase III are larger, multi-center studies for which many people with the condition you hope to treat are recruited. Phase III studies may compare the medication to placebo or test the standard treatment against a new treatment. Phase IV are generally post-marketing studies in which researchers look at a new condition that may be treated with the medication or long-term adverse effects of a drug, for example. 

The Bassett Research Institute has done all four types of studies and is capable of doing the full range but is typically involved in Phase III clinical studies.

Bassett Healthcare has experience in a wide range of study areas and receives grant funding from a variety of organizations. For a complete list of funding sources, please contact Jennifer Victory. 

Jennifer Victory, RN, CCRC
Clinical Research Nurse Supervisor
Clinical Research Division
Bassett Healthcare Network
One Atwell Road
Cooperstown, NY 13326
(607) 547-6965 or 1-800-BASSETT
 jennifer.victory@bassett.org