|
Since its opening in November 2002, the Bluestone Center for Clinical Research
has conducted nearly three dozen studies in areas ranging from new head
and neck cancer treatments to dental implants to the management of hyperglycemia
in diabetics with periodontal disease. A complete list of trials appears
on pages 50 - 51.
According to the Bluestone Center’s Director, Dr.
Jonathan Ship, a Professor of Basic Science and Craniofacial
Biology and of Oral Medicine at NYUCD, and a Professor of Medicine
at the NYU School of Medicine: “Industry
has responded positively to our model of intellectual manpower minus
the bureaucracy traditionally associated with academic research,
awarding $3.5 million in grants in under two years. As a result,
we are well positioned for new growth, particularly in Phase
I-IV trials and the development of new drug applications.”
At
over 8,500 square feet, the Bluestone Center is the largest
clinical research center in a dental school and the only one
with overnight facilities for patients participating in 24-72
hour clinical studies. In the past two years, the center has
recruited a pharmacotherapy research chief and four new clinical
research coordinators, creating a breadth and depth of talent
and experience for the conduct of both dental and medical research
sponsored by both industry and federal agencies such as NIH/NIDCR.
Dr.
Frederick A. Curro, Chief of Pharmacotherapeutic Research,
cites the fact that the Bluestone Center offers a full spectrum
of regulatory services for drug development as a major draw.
Dr. Curro has been responsible for an increase in awards from
small biotechnology companies to develop and execute Phase I-IV
trials and FDA submissions.
A total of five clinical research
coordinators are cross-trained to participate in multiple trials
simultaneously. Three of the coordinators are certified by
the Association of Clinical Research Professionals and the other
two will soon complete their certification. One coordinator
is working primarily on trials involving oncology research faculty
collaborators from nearby Beth Israel Hospital Medical Center.
Bluestone
Center’s
Executive Administrator, Rene Lopez, who is responsible
for contract negotiation, quality assurance, and overall administrative
functions, notes that “Before we opened, a quick turnaround
time for contracts was two weeks; now, with a single contact
person and the inroads that we have established with the
NYUSM Office of Clinical Trials —
we can complete a contract in as little as 24 hours. For example, when
one sponsor called to say they had a tight deadline for commissioning
new research, we completed the contract in a day.”
Negotiations are
currently underway to bring more than 15 new Phase I-IV clinical
trials and drug development projects to the Bluestone Center.
Dr. Ship said that the growth in part reflected the faculty’s
growing familiarity with and eagerness to use the facility. “We
have worked hard to integrate Bluestone into NYUCD’s culture
and have provided faculty-to-faculty training in Good Clinical
Practice guidelines, clinical research standards, and clinical
trial development and conduct,” he
said. He added that the Bluestone Center would be able to accommodate
future growth by tapping into the graduating classes of NYUCD’s MS
degree and Certificate Programs in Clinical Research, which use Bluestone’s
facilities to train their students. In fact, one of Bluestone’s research
coordinators, Dr. Hanae Saito, was one of the first two graduates
of the MS in Clinical Research program, and another coordinator,
Concetta Mangiaracina, received a Certificate in Clinical Research
and is studying part-time for her MS degree.
Dr. Ship said he expected
that Bluestone would also increasingly tap into faculty from other
institutions for collaborative research ventures. Dr. Ship’s appointment
as a Professor of Medicine at the NYU School of Medicine is expected
to increase cooperation with clinical researchers there. “At
the same time,” Dr. Ship added, “internationally recognized researchers
who joined NYUCD’s faculty in the
past few years are making connections for us at colleges overseas.
We are only beginning to tap into our full potential to make an
impact on oral health worldwide.”
Industry- and NIH-Sponsored Studies
Awarded to the Bluestone Center for Clinical Research from November
2002-August 2004*
Oral Medicine |
|
Study Title |
Investigators** |
Clinical Evaluation of a New
Technique for Detecting Suspicious Oral Lesions with Oral
Speculoscopy |
A. Ross Kerr (PI), Miriam R.
Robbins, David A. Sirois, Silvia E. Spivakovsky, William
C. Ullman |
Efficacy & Side
Effects of the Topical Application of a Novel Agent in
the Treatment of Minor Aphthous Ulcers |
A. Ross Kerr (PI)
|
Women's Interagency HIV Study
(WIHS) |
Joan Phelan (PI) |
Open-Label, Dose-Escalation,
Phase I Clinical Study to Assess the Safety of a Novel Agent
in Patients with “Pemphigus Vulgaris” Requiring Daily Corticosteroid
Therapy |
Bruce Strober1 (PI), Jonathan
A. Ship |
Phase III, Double-Blind Trial
of a Novel Agent in Post-Radiation Therapy Patients with
Xerostomia |
Jonathan A. Ship (PI) |
Phase III, Open-Label, Long-Term
Safety Study of a Novel Agent for Xerostomia |
Jonathan A. Ship (PI) |
High-Dose Rate Intraoperative
Radiation for the Management of Metastatic Squamous Cell
Cancer |
Kenneth Hu2 (PI), Jonathan A.
Ship |
Phase II, Multicenter, Double-Blind,
Placebo-Controlled, Parallel-Group, Dose-Ranging Study of
the Effects of a Novel Agent on Oral Mucositis |
Kenneth Hu2 (PI), Jonathan A.
Ship |
Phase III, Randomized, Multicenter,
Placebo-Controlled Study of a Novel Agent for Oral Mucositis |
Kenneth Hu2 (PI), Jonathan A.
Ship |
Chemoradiation, Neck Intraoperative
Radiation Therapy, and a Novel Agent for Head and Neck Cancer
with High-Risk Neck Disease |
Kenneth Hu2 (PI), Jonathan A.
Ship |
A Randomized, Observer-Blind,
Cross-Over Design Study Comparing the Effects of Two Commercial
Non-Prescription Mouth Rinses on Salivary Flow Rates and
Xerostomia |
Jonathan A. Ship (PI), Ronald
Katz, A. Ross Kerr, Jane A. McCutcheon |
Protocol Development for Phase
III Study of a Novel Agent for Xerostomia |
Jonathan A. Ship (PI), A. Ross
Kerr, Jane A. McCutcheon |
Prospective, Double-Blind,
Placebo-Controlled, Multicenter Trial to Assess the Efficacy
and Safety of a Novel Agent for “Pemphigus Vulgaris” |
David A. Sirois (PI), A. Ross
Kerr, Miriam R. Robbins, Jonathan A. Ship |
Oral Cancer Detection: Current
and Emerging Technologies |
David A. Sirois (PI), A. Ross
Kerr, Miriam R. Robbins |
| |
|
Periodontics |
|
Pilot Study of a Novel Agent:
Effects of Glycemic Control in Subjects with Type 2 Diabetes
and Chronic Periodontitis |
Ron G. Craig (PI), Angela R.
Kamer, Eva M. Lupovici |
Periodontal Assessment and Rheumatology
Arthritis Study (PARAS) |
Clifton Bingham1 (PI), Ron G.
Craig, Angela R. Kamer, Denise Estafan, Khalid Almas, Jonathan
Ship |
Periodontal Disease and Prematurity |
Ananda Dasanayake, Ronald Craig,
Douglas Morse |
Calibration Study of Two Commercially
Available Dentrifice Formulations on the Prevention of Gingivitis
and Plaque Formation |
Bapanaiah Penugonda (PI), Diana
L. Galvis |
IND Development for a Novel Agent
for Gingivitis |
Frederick A. Curro (PI), Ron
G. Craig, Jane A. McCutcheon |
| |
|
Implants |
|
Study to Compare A Non-Traditional
Implant System vs. Two Traditional Implant Systems with Regard
to Changes in Marginal Bone Level |
Nicholas Elian (PI), Stuart Froum,
Dennis P. Tarnow , Stephen S. Wallace, Sang-Choon Cho, Ziad
Jalbout |
Clinical Comparison of Healing
Extraction Sockets Following Implantation of a Xenograft
Absorbable Bone Graft With or Without an Absorbable Membrane
Barrier |
Stuart Froum (PI), Dennis P.
Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
Post-Approval Study for Evaluation
of a Novel Agent for Periodontal Disease After Multiple Treatments |
Stuart Froum (PI), Dennis P.
Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
Histological Comparison of an
Allograft to an Organic Bovine Bone Mineral in Maxillary
Sinus Grafting |
Stuart Froum (PI), Dennis P.
Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
Open, Randomized Study to Compare
Two Dental Implant Systems with Regard to Changes in Marginal
Bone Level |
Dennis P. Tarnow (PI), Stuart
Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
Protocol Development of Comparative
Efficacy of a Non-Traditional Implant vs. a Traditional Implant |
Farhad Vahidi (PI), Van P. Thompson |
Survival Rate of Novel Direct
One Piece Dental Implants When Placed With a Flapless or
Flap Protocol |
Dennis P. Tarnow (PI), Stuart
Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
Histomorphometric Comparison
of Two Materials in Maxillary Sinus Grafting |
Dennis P. Tarnow (PI), Stuart
Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho,
Ziad Jalbout |
| |
|
Pain |
|
IND Clinical Development Plan
for a Novel Agent for Post-Operative Dental Pain |
Frederick A. Curro (PI), Robert
S. Glickman, Jane A. McCutcheon |
Dose Response Study on a Novel
Agent for Toothache |
Jonathan A. Ship (PI), Silvia
E. Spivakovsky, Stanley N. Turetzky |
Phase III, Randomized, Multicenter,
Parallel-Group, Double-Masked, Placebo-Controlled Study of
the Safety and Efficacy of a Novel Agent in the Treatment
of Post-Operative Dental Pain |
Robert S. Glickman (PI), Kenneth
E. Fleisher |
Phase III, Double-Blind, Randomized,
Placebo-Controlled Study of the Effect of a Novel Agent on
the Rate of Recovery from Soft-Tissue Anesthesia and on Safety
in Dental Patients |
Andrea S. Schreiber (PI), Eva
M. Lupovici, Kenneth L. Allen |
| |
|
Restorative |
|
Open-Label Clinical Study of
a Novel Bur on Class I Carious Lesions |
Kenneth L. Allen (PI), Gerald
Klaczany, James T. LoPresti, Van P. Thompson |
Microbial Diversity and Characterization
of Cariogenic Biota |
Page Caufield (PI), Ananda Dasanayake,
Yihong Li |
Clinical Evaluation of A Novel
Composite Resin and Two Novel Bonding Resins |
Benjamin Godder (PI), James T.
LoPresti, Gerald Klaczany, Van P. Thompson, Douglas Pollack,
Robert Blashka |
Single-Blind Clinical Study of
Polymer Dentin Removal Burs on Class V Carious Lesions |
James T. LoPresti (PI), Kenneth
L. Allen, Gerald Klaczany, Van P. Thompson |
| |
|
Aesthetics |
|
Single-Blind Study of the Efficacy
and Sensitivity of Four Dental Whitening Systems |
Ivy Peltz (PI), Eric S. Studley,
Evelyn A. Nelson, Andrew B. Schenkel, Arnold Rosenstock,
Jay W. Schwarz |
Clinical-Efficacy Determination
of Prototype Liquid Whitener |
Bapanaiah Penugonda (PI) |
Extrinsic Stain Removal by Chewing
Gum |
Warren I. Scherer (PI), Alan
H. Rattet, Harry G. Meeker |
| |
|
Prosthodontics |
|
Implant Overdenture Prospective
Study |
Leila Jahangiri (PI) |
| |
|
Epidemiology and Behavioral
Science |
|
Dental Alliances to Reduce Tobacco
(DART) |
Gustavo Cruz (PI) |
| |
|
Education |
|
The Effect of an Interactive
CD and the Use of Chewing Gum on Learning Dental Anatomy |
Kenneth L. Allen (PI), Ralph
V. Katz |
Notes
* Over 15 Phase I-IV clinical trials and IND development projects
in a variety of fields are currently in the contract and budget
negotiation phase.
** All investigators are NYUCD faculty unless otherwise
noted.
1 NYU School of Medicine faculty
2 Beth Israel Hospital Medical Center
faculty |
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