CTSI
 
MASTERS OF SCIENCE IN CLINICAL INVESTIGATION
K30 PROGRAM: TRANSLATIONAL MEDICINE

ABOUT THE PROGRAM
The rapid strides and advancement of biomedical discoveries present an opportunity for clinical care to further improve upon disease prevention, diagnosis, and management. The goal of this training program is to train clinician-scientists in the skills necessary to translate scientific discoveries to clinical settings, to determine the efficacy and outcomes of new and established therapy and identify, using epidemiologic and statistical tools, the health problems of the future. The program is intended for persons who have completed residency training in a clinical department.

PROGRAM ELEMENTS

Course Descriptions

Clinical Research Methods
This course reviews core epidemiologic and research principles, providing students with the basic building blocks for developing their knowledge and skills in conducting clinical research.

Introduction to Biostatistics
This course involves the introduction to probability and statistical methods utilized in the analysis and interpretation of experimental and epidemiological data with applications in biology, medicine, and the health sciences.

Advanced Epidemiology
This course is designed to introduce students in all fields of public to the background, basic principles and methods of public health epidemiology. Topics covered include: measures of disease frequency and risk; epidemiologic study designs, both experimental and non-experimental; understanding bias; and measures of effect and association. In addition, students will develop skills to read, interpret and evaluate health information from published epidemiological studies and mass media sources.

Developing New Drugs
The overall goal of this course is to provide an overview of new drug development to entry-level professionals in the medical sciences. Seminars consist of a combination lecture and discussion, and will included invited lecturers from both the academic and private sector. Completion of this course will enable each participant to 1) learn the vocabulary and principles of new drug development 2) assess the non-clinical background of a drug, 3) learn practical skills for interacting with regulatory agencies during the course of new drug development, and 4) discuss the financial and marketing issues behind new drugs.

Integrative Seminar
This weekly conference over two years will be a forum for review of important issues in Clinical Research and for presentation of research projects by the students.

  • Year 1: Will cover Survival Techniques for Young Investigators in Biomedical Research followed by a two-part series on the History of Medicine.
  • Year 2: Will address Skills and Strategies for Grant Writing, Identifying Funding Sources, Manuscript Preparation and Publication; and Scientific Presentation Skills.

Scientific Integrity and Responsible Conduct of Clinical Research
This course is required by the NYU School of Medicine and provides important insights into general scientific ethics, regulatory responsibilities, ethical consideration of human subjects, and research reporting and intellectual property.

Clinical Trials Design
The goals of this course include: understanding the study question and the significance of addressing the question; identifying eligibility criteria; describing the intervention; selection of outcome measures including power and sample size calculations; and developing an effective analysis plan.

Biomolecular Medicine
The specific objectives of the course are to use a “case-based” approach to the uses and pitfalls of such technologies as gene microarrays, proteomic analysis, knockout and transgenic mice, high throughput screens for drug targets, siRNA and flow cytometry.

Medical Informatics
This course will serve as an introduction to Medical Informatics, which is the interdisciplinary science of information management in Medicine.

Grant Writing
This course provides intense didactic information on the development of grant applications to the US Public Health Service. After reviewing research design issues briefly, the course provides instruction on the development of a research abstract, aims, background, preliminary studies, methods, human subjects protection issues, budgets and budget justification, and forms. Following the didactic sessions which are interactive, the students are to develop a complete R01 application using a standard NIH format within 30 days of the start of the course. Following this, a didactic session covers peer review, and students are assigned as scientific peer reviewers for submitted applications

Mentored Research Project

The most critical component of this degree program is the opportunity for trainees to apply what they are learning in class in a mentored research project. Each trainee will be mentored at a number of levels. They will work most closely with a research mentor within their Division who will supervise the development and implementation of the study. In regular meetings, they will plan the design and troubleshoot the progress of the project.
Each trainee will also meet, every six months, with the program executive committee. Prior to this meeting, the committee will seek an update of the trainee’s progress from the research mentor. The goals of these periodic meetings are to establish and review individual learning goals, plan choice of elective courses, review research progress, and troubleshoot programmatic issues.
Finally, peer mentoring will occur in monthly works in progress presentations during the Integrative Seminar. Trainees will benefit from the focused feedback from the group and develop their own skills at critical review and constructive feedback of research protocols.

Eligibility and Admissions

Upon entrance to the program, an applicant must be:

  • Board Eligible or Certified in a Clinical Specialty
  • An active participant in clinical investigation
  • Currently licensed to practice medicine in New York State

Application deadline: February 19, 2010


Curriculum
This Master's program curriculum consists of a total of 36 credits, as outlined below. Courses are taught by faculty at the School of Medicine, the Wagner Graduate School of Public Service and the Graduate School of Arts and Sciences.

 

Term

Course Title

Credits

Year 1

Summer

  • Clinical Research Methods
  • Introduction to Biostatistical Analysis

3
3

Fall

  • One of:
    • Advanced Epidemiology -  U10.2450.001
    • Developing New Drugs
  • Integrative Seminar

 

3
3
1

Spring

  • Scientific Integrity and the Responsible Conduct of Research
  • Clinical Trial Design
  • Biomolecular Medicine
  • Integrative Seminar
  • Independent Research

0
4
4
1
1

Year 2

Fall

  • Medical Informatics
  • Integrative Seminar
  • Independent Research

3
1
3

Spring

  • Integrative Seminar
  • Independent Research

1
5

 

 

 

36

Schedule
Please see below for an outline of the course and activity schedule:

First Year (July – June)

Summer:
Courses Tuesday and Thursday mornings, Thursday afternoons
Fall & Spring:
Courses Wednesdays (all day), Thursday afternoons (for some)

Second Year (September – June)

Fall:
Courses Wednesdays (all day), Thursday afternoons (for some)

Spring:
Courses Wednesdays (all day), Thursday afternoons (for some),
2-3 evenings per week for Grant Writing course which lasts for 3 weeks in January