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Masters of Science in Clinical Research


1. Educational Goals and Objectives:
The Goal of this program to produce competent and knowledgeable clinical investigators to serve universities, regulatory agencies and industry.

2. Overview:
There is a nationally recognized shortage of adequately trained clinical researchers. To set the context for future clinical research activities, the NIH convened a Director's Panel in the late 1990s. This panel consisted of clinical researchers with expertise in general medicine, pediatrics and surgery. They recognized the state of clinical research as a national problem and made certain recommendations. These recommendations included improving the quality of clinical research training, initiating training programs to attract students into clinical research careers, and educating the public about the importance of clinical research.

Furthermore, as new discoveries emerge from the laboratory, clinical trials are needed to take these discoveries into the next generation of products. As a result, increasing numbers of investigators are conducting clinical trials today. In 1990, there were only 5,000 physicians and pharmacists who conducted clinical trials of new drugs. Today, over 50,000 health professionals have assumed the role of principal investigator in clinical trials. An estimated 45,000 to 60,000 Phase I to III protocols are conducted annually in the United States. In total, 750,000 to 900,000 study subjects will complete clinical trials for new drug applications. Currently, there are 30, 527 clinical trials that are recruiting subjects (as of Oct 30, 2005) that are listed on the National Institutes of Health Web site (http://clinicaltrials.gov/) and of these, 246 are related to mouth and tooth diseases. As the numbers of clinical trials in general and within dentistry in particular, are rapidly increasing, there is a great need to train clinicians to conduct clinical research and clinical trials so that they may conduct these studies using the highest scientific, ethical and regulatory standards.

In keeping with the above described need, NYU College of Dentistry initiated a Clinical Research Training Program in 2000. The Master of Science in Clinical Research degree offered through the College is a two-year, full-time program, which provides a rich mix of didactic course work and mentored clinical research training (50 total credit hours). Together with hands-on experience in clinical research provided in the newly constructed Bluestone Center for Clinical Research (BCCR); students who enroll in this program are exposed to a wide array of topics related to clinical research provided by a group of experts from academia and industry.

Eligible applicants for the MS program are individuals from academia and industry with backgrounds in dentistry, medicine, nursing, pharmacy and other allied health professions or who possess a minimum of a B.A. or a B.S. degree. Tuition for the program is according to the standard per credit tuition fee for the Graduate School of Arts and Science at NYU ($1080 per credit in 2006). Full-time students will be eligible for NYU housing.

3. Accreditation Status:
This program is approved by the New York University and the NY State Department of Education.

4. Length of Program:
The Masters of Science in Clinical Research degree is a two-year full-time program (or a 4 year part-time program) with 12 -14 credit hours of course work per semester. The MS degree has a total of 50 credit hours.

5. Courses by Year:

1st Year (26 Credits)

Fall:
D60.7020-001 LIT REVIEW OF CLINICAL STUDIES I: BASIC SKILLS (3.0)
D60.7030-001 FUND OF CLINICAL TRIALS I (3.0)
D60.7040-001 BIOSTATISTICS I (3.0)
D60.7050-001 FEDERAL REGULATIONS & FEDERAL AGENCIES (1.0)
D60.7060-001 FUND OF DATA MANAGEMENT I (2.0)

Spring:
D60.7014-001 BIOSTATISTICS II (3.0)
D60.7025-001 LITERATURE REVIEW OF CLINICAL STUDIES II (2.0)
D60.7035-001 FUNDAMENTALS OF CLINICAL TRIALS II (3.0)
D60.7065-001 FUND OF DATA MANAGEMENT II: QUALITY CONTROL (1.0)
D60.7080-001 BIOETHICAL ISSUES & IRB SKILLS (2.0)
D60.7090-001 SCIENTIFIC WRITING: PROTOCOLS AND GRANTS I (3.0)

2nd Year (24 credits)

Fall:
D60.7011-001 RETROSPECTIVE RESEARCH DESIGNS (3.0)
D60.7012-001 SCIENTIFIC WRITING: PROTOCOLS AND GRANTS II (3.0)
D60.7013-001 INDEPENDENT STUDY IN BIOETHICS (3.0)
D60.7016-001 PRACTICUM IN CLINICAL RESEARCH CENTER I (3.0)
(In addition to the 2 hours of lectures, this class requires an additional 4 hours of assigned practicum per week during normal business hours per semester)

Spring:
D60.7017-001 LITERATURE REVIEW OF CLINICAL STUDIES III (4.0)
D60.7018-001 VIRTUAL CLINICAL TRIAL PRACTICUM (4.0)
D60.7019-001 DATA MANAGEMENT AND ANALYSIS PRACTICUM (2.0)
D60.7021-001 PRACTICUM IN CLINICAL RESEARCH CENTER II (2.0)
(In addition to the 2 hours of lectures, this class requires an additional 4 hours of assigned practicum per week during normal business hours per semester)

6. Admission
Applicants for the M.S. program must possess a minimum of a B.A./B.S. degree and/or a professional degree in dentistry, medicine, nursing, pharmacy or other relevant professional field. Applicants must submit the following items as part of the admissions process:
1. A completed copy of either the online application or a hard copy of the application
2. A personal letter of interest including specific career goals
3. A current resume
4. Official copies of all college and professional school transcripts
5. Official copies of scores on all National Standardized Tests taken for admission to prior programs of study, e.g. DAT, MCAT, GRE, etc.
6. Official copies of all National Examinations taken on achievement, e.g., Part I and Part II of U.S. National Boards in dentistry or medicine, or comparable examinations in other fields or countries
7. For non-U.S. applicants from countries where English is not the official language, an official copy of TOEFL scores is required and all foreign credentials must be evaluated by Educational Credential Evaluators (ECE) - http://www.ece.org
8. Three letters of recommendation, at least two of which must be from former teachers
9. Application fee of $100 as a check or money order made payable to New York University College of Dentistry

The selection process will initiate when the applicant has fulfilled all of the above required items related to admissions. Completed applications submitted by February 28th for the desired September program commencement will be given priority and depending on the availability of slots, late applications received up to June 30th will be considered. The Admissions Committee will review only completed applications and will select the leading applicants for interviews. Interviews are a required element of the application process, and direct personal interviews at NYU are strongly encouraged. However, in exceptional cases (e.g., international distance and high cost of travel) telephone interview(s) may be substituted for the direct personal interview at the discretion of the Admissions Committee. Applicants will generally be notified of the admission decision within 6-weeks of the receipt of the completed application.

Further inquiries about the program and applications can be submitted to:
Juliana Cools
Program Coordinator
212-998-9934 (T)
212-995-4317 (F)
jc1290@nyu.edu
or
Dr. Ananda P. Dasanayake
Director, Graduate Program in Clinical Research
212-998-9631 (T)
212-995-4788 (F)
ad75@nyu.edu
Website: http://www.nyu.edu/dental/advanceded/clinicalresearch/msprogram.html

References:
1. IDCR. NIH Directors Panel on Clinical Research 1998:
http://www.nidcr.nih.gov/about/nadcrc/nadrc198.htm
2. Ginsberg D. The Investigator's Guide to Clinical Research. Ken Getz (Publisher) 2002; Page 3.
3. Center Watch. Grant market to exceed $4 Billion in 2000. Center Watch Newsletter 2000;7(11):6-10.