Clinical Research
We have an experienced staff of six clinical research coordinators led by Jane Downs, RN, CCRC who manages all details necessary for participation in these research projects. Our research coordinators review the details of any study on an individual basis with patients and/or family members. The research coordinator will explain the intent of the study, the inclusion and exclusion criteria for participation, the potential hazards and side effects of the medication(s) being studied, and the financial or time commitment requirements of the study. They will then review the details of the informed consent with patients and family members.
Clinical research is conducted at several levels. Before the FDA approves any medication, there is considerable background laboratory research that culminates in preliminary safety studies known as Phase I trials. Following Phase I trials, medications are then subjected to Phase II and Phase III trials that may ultimately culminate in FDA approval of the medication.
Phase II studies are preliminary or pilot trials designed to explore a medication’s potential therapeutic efficacy. Phase II trials are in a sense a “grand jury” following which a drug may be subjected to more extensive Phase III trials. RNA has participated in several Phase II clinical trials. The GLANCE study investigating the potential use of Copaxone® (glatiramer acetate) in conjunction with a new medication called Tysabri® for multiple sclerosis is one example of a Phase II trial. RNA was one of many sites across the US and Canada where the study was undertaken. We are also one of several sites participating in a study of a medication for insomnia being developed by Aventis Pharmaceuticals.
Phase III clinical trials are double blind, placebo controlled studies that ultimately decide if a medication will become FDA-approved. An example of such a study is the SENTINEL trial which has led to the approval of the use of Tysabri® for relapsing multiple sclerosis. Raleigh Neurology Associates was one of over 100 centers in the USA, Canada, and Europe. Another example of a Phase III study is the Rotigotine "patch" study for Parkinson's disease investigating the benefits of receiving a medication via a patch on the skin rather than orally.
Phase IV clinical trials are post-marketing studies that investigate issues in medications that are already FDA approved for use. The Menstrual Migraine Study for GlaxoSmithKline was one example of a Phase IV clinical trial RNA has conducted researching the benefits of Imitrex for this secondary indication.
On this Web site we have listed the completed studies in which RNA has participated. We list these to give our patients a sense of the extensive clinical experience our research coordinators and physicians have successfully conducted within FDA guidelines. RNA is highly regarded among pharmaceutical companies and contract research organizations (CROs) as a center experienced in participating in clinical research. Independent study monitors and pharmaceutical company representatives regularly audit our center to insure the accuracy and safety of the studies. We seek to be able to provide patients access to high quality clinical research in the comfortable setting of our office.
We have also listed the studies for which we are currently enrolling patients. Please feel free to contact one of our studies coordinators for more specific information concerning any of these studies. You may also contact Jane K. Downs, RN, CCRC, Research Director at 919-420-1659 or jdowns@raleighneurology.com.
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