Spring 2006 Table of Contents
Research in Focus
Bluestone Center Offers Patients Special Treatment

Dr. Jonathan Ship

Until recently, Zelda Brand, who received her B.A. from NYU in 1945 and her M.A. in 1947, couldn’t taste the food she ate. After enduring cancer surgery and radiation that resulted in the removal of her vocal cords, she had lost the use of her salivary glands.

But since participating in a clinical trial at the College of Dentistry’s Bluestone Center, where Brand received a new medication that was carefully monitored, she has regained the ability to salivate and, thus, experience the joy of tasting foods again. Says Ms. Brand, “It was wonderful, a marvelous experience.
I recommend it to anyone.”

The Bluestone Center is the largest dental-school based facility in the United States built specifically to investigate promising new medical and dental treatments before they are available on the market. In addition to being the largest center of its kind in the nation, the 8,500 square-foot Bluestone Center is also the only one with bedrooms for patients who have to be closely monitored overnight. While the vast majority of clinical trials do not require an overnight stay, patients who do stay overnight can expect a room with private bath and shower, cable TV and Internet access, plus whatever they want to eat, if it’s available at a Manhattan restaurant or deli that delivers.

“The only way to develop safe new drugs for patients is to test them in a controlled environment in accord with the strictest government regulations and ethical guidelines,” says Dr. Jonathan Ship, Director of the Bluestone Center. “Our strategy is to combine academic excellence with industry’s efficiency and speed. In order to do that, we must aggressively market participation in clinical research. But we always stay focused on the needs and desires of individual patients.”

At the Bluestone Center, a team of physicians, dentists, nurses, and specially-trained clinical research coordinators from NYU’s College of Dentistry, College of Nursing and School of Medicine conducts outpatient and overnight Phase I – IV research studies in a wide range of medical and dental areas. Each phase answers different questions about the new treatment.

Medical trials include analgesics, anti-inflammatory drugs, sedatives, cancer therapy, sleep apnea medications, anxiolytics, and dermatology products. Oral health trials might consider new dental devices and restorative materials, dry mouth and mucositis, oral lesions and cancer, periodontitis, implants, dental caries, whitening and anti-plaque products, and oral facial pain.

In Phase I studies, researchers look for the best way and how frequently to safely administer a new treatment; e.g., by mouth, IV drip, or injection. They also watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include a limited number of subjects, between 15 and 30, who would not be helped by existing treatment therapies.

Phase II trials continue to test the safety of the new treatment, and begin to evaluate how well it works against a specific disease. As in Phase I, only a small number of people (usually less than 100) take part. When a Phase II trial begins, it is not yet known if the agent being tested works against the specific disease being studied.

Phase III trials focus on how a new treatment compares to standard treatment. In most cases, studies move into Phase III testing only after a treatment shows safety and efficacy in Phases I and II. Phase III trials may include hundreds to thousands of people at many clinical centers. In Phase III trials, people are assigned at random to receive either the new treatment or standard treatment.

Phase IV trials are used to further evaluate the long-term safety and effectiveness of a treatment. Less common than Phase I, II, and III trials, Phase IV trials usually take place after the new treatment has been approved for standard use.

“In addition to receiving special attention for a medical or dental condition, participating in Bluestone Center clinical trials offers patients an excellent way to understand clinical research,” says Dr. Ship. “It also provides an opportunity to help others who may be suffering from a common or rare disease or illness, now or in the future.”