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Biostatistics Facts and Figures, 2007-2008:
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Department of Biostatistics 
Clinical Research Design and Statistical Analysis (M.S.) Program Brochure
Objective and Rationale
The On Job/On Campus (OJ/OC) Master of Science (M.S.) program, Clinical Research Design and Statistical Analysis (CRDSA) is designed for health care professionals who are involved in clinical research. It helps them develop expertise in research design and statistical analysis while continuing their professional employment.
The CRDSA Program is designed to improve the quality of clinical research and to address the shortage of persons with clinical expertise who are trained in research methods. These problems reflect the increasing complexity of clinical research, the increasing value of that clinical research, and the limited training of health care professionals in research design and statistical analysis. Most clinical training programs include only minimal statistics and research design since only a small number of their students will become researchers. This CRDSA program is designed specifically to teach the skills and knowledge needed to carry out clinical research.
Who Should Apply
Many of the previous participants have been faculty and researchers employed by medical, dental, pharmaceutical, and nursing schools, teaching hospitals, research institutes, and research divisions of pharmaceutical and medical firms. Many participants have been in fellowship programs that involve clinical research.
Non-Residential Format
The University of Michigan School of Public Health pioneered the non-residential OJ/OC format in 1972. Approximately 300 students have successfully completed the CRDSA program since then. Participants meet in Ann Arbor at the School of Public Health for a four-day weekend (Thursday, Friday, Saturday, and Sunday) once every four to five weeks for thirty hours of class time. Between weekends on campus, participants complete course assignments and work on projects while remaining on their jobs. This Master of Science Degree Program lasts eighteen weekends spread over eighteen to twenty months.
Future Program Dates
Cohort XIII
October 2007-April 2009
Cohort XIV
October 2009 - April 2011
Specialized Track That Includes a Mentored Clinical Research Project
The University of Michigan Medical School has developed several specialized tracks within the CRDSA program that include a mentored clinical research project and supplemental courses. Acceptance into the track requires acceptance into the CRDSA program, followed by approval of the mentoring program admissions. Since the supplemental courses are not taught on the weekend, this track is only open to students whose schedules allow classes and seminars at other times. Phone (734) 615-3487 for more details about their program.
Integration with Employment
Each student's work setting provides a personal research laboratory; and many of the program's assignments are created with the work setting in mind. Participants design and implement research projects, review proposals, and critique literature in their fields. The integration of work and academics increases the effectiveness of the program by making it part of, rather than isolating it, from practice.
Program Content
The content of the program can be defined in a number of ways: the purposes of research, research design concepts, data collection methods, and statistical or analytical methods. The program provides concepts and methods that relate to the purposes of clinical research, clinical epidemiology, clinical trials, program evaluation, and technology assessment. Research design concepts include the traditional approaches to the scientific method; the concepts of validity, reliability, causal relationships, role of randomization, standards for comparison, and sampling, as well as other recently developed methods of approaching decisions about research outcomes such as decision analysis and cost-utility analysis. The data collection methods deal with instrumentation, questionnaire construction, nonreactive measures, survey techniques, qualitative data, measurement and standardization problems, concepts and criteria of normalcy, and disease and diagnostic criteria. Statistical techniques for estimation and hypothesis testing, including comparison of proportions, chi-square test, comparison of means, analysis of variance and covariance, multiple regression analysis, logistic regression, and survival analysis are presented.
In addition to a comprehensive curriculum in research design and statistical analysis, other content relevant to clinical researchers is included: ethical and legal issues in clinical research, technical writing skills and proposal/report writing, management of research, and behavioral factors in clinical research. Students learn computer skills and concepts, including data file management, data organization, and use of statistical packages. Visiting faculty with experience in specialized research subjects meet with the students to discuss current problems in clinical research.
Admissions
The MS in CRDSA is administered through the Horace H. Rackham School of Graduate Studies. To apply for the CRDSA program please fill out a Rackham School application. All applicants should document their current or potential involvement in research such as clinical studies, clinical research, clinical epidemiology, or clinical trials. Applicants should have either experience or graduate training in a clinical field and have at least one year of college mathematics. All applicants must submit documentation of analytic skills. Scores from the GRE or MCAT (applicants with MCAT scores below double digits in more than 3 areas are strongly encouraged to take the GRE) or a transcript showing coursework and grades of B+ or better in 2 or more college-level mathematics or statistics courses will generally provide sufficient documentation. Information on the GRE is available either by phone at 1-800-GRE-CALL or visit the GRE Website at http://www.gre.org/.
The CRDSA program accepts new applicants on a rolling admission basis until the cohort is full.
The Biostatistics Department does not have funding available for students in this program. Most students fund themselves or receive funding support from their employer. Students may apply for financial aid through The University of Michigan's Office of Financial Aid. This office requires applicants for any and all types of financial aid to complete the Free Application for Federal Student AID (FAFSA) provided by the American College Testing Center (ACTC). A FAFSA will be sent to you directly if you indicate your interest in financial assistance on the admission application form.
Application Procedure
Those wishing to apply to the CRDSA program must submit the following supplemental materials in addition to a complete Rackham Application and non-refundable application fee:
- Official transcripts of all college-level education
- Three letters of recommendation
- Statement of Purpose
- Curriculum Vitae
- Documentation of analytic skills (please see Admissions information above for details)
- International students whose first language is not English must also submit TOEFL or MELAB scores
All supplemental application materials should be mailed to:
Biostatistics Department
OJ/OC Program in CRDSA
University of Michigan
1420 Washington Heights
Ann Arbor, MI 48109-2029
Questions regarding admissions or the application process may be directed to:
By Telephone: (734) 615-9812
By Fax: (734) 763-2215
By E-mail: sph.bio.inquiries@umich.edu
Statistics Preparation
All students should have completed an introductory statistics course before enrollment. Applicants who have not had such a course recently, and who do not use statistics routinely in their work, should take an introductory applied statistics course before beginning the program.
Computing Access
To receive the full benefits of this program, students must have access to a personal computer (PC recommended) with at least 64 megabytes of RAM, running a recent version of Windows. Students also must have access to the internet and e-mail through a modem or other type of connection. Students can use one of the many com-puters at any of the University of Michigan's Computing Sites while they are in Ann Arbor, but need access to their own machine at other times.
Clinical Studies; Clinical Investigation; Clinical Epidemiology
These studies concentrate on identifying the natural history of a disease, causal factors in disease, or treatment effects. The purposes of such studies include definition of new syndromes or disease entities (case definition), describing normal organ function, developing new diagnostic methods or new diagnostic criteria, describing the distribution of a syndrome or entity in time, place, or person, and developing hypotheses about new therapies or etiology. The studies are usually observational or descriptive in nature, and use quasi-experimental designs such as a before/after design. They sometimes involve stratification but almost never randomization.
Institutional Epidemiology; Post-Marketing Surveillance
These studies consider ways of monitoring rare events for the purposes of identification of possible new disease entities or syndromes and side effects of treatment modalities. They generally involve concomitant data collection for the purpose of identifying deviation from an expected value.
Cost-Benefit Analysis; Technology Assessment
Cost-Benefit Analysis evaluates the efficiency of alternative treatment modalities and secondary impacts of new or alternative treatment modalities on health care manpower, financing, and institutions.
Clinical Trials
Clinical trials probe treatment modalities for such purposes as establishing efficacy, setting dose levels, and examinations of side effects. The studies almost always involve experimental designs incorporating randomization.
Outcomes Research
Evidence based medicine uses outcomes research to improve clinical decision making and to develop practice guidelines. Both intervention and observational studies are used to assess patient outcomes resulting from different practice patterns. Key components include monitoring of practices and outcomes, assessment of variation, comparisons with adjustment for case mix, and feedback and information to the community.
To request an information packet via the Web, go to:
http://inquiry.embark.com/Umich/PublicHealth/
For further program information, contact:
Trivellore Raghunathan, Ph.D., Program Director
OJ/OC M.S. Program in Clinical Research Design and Statistical Analysis
Department of Biostatistics
University of Michigan
School of Public Health
1420 Washington Heights
Ann Arbor, MI 48109-2029
Faculty
- Mousumi Banerjee, Ph.D., Associate Research Scientist, Biostatistics, University of Michigan
- Michael Elliott, Ph.D., Assistant Professor, Biostatistics, University of Michigan
- Brenda Gillespie, Ph.D., Assistant Professor, Biostatistics, University of Michigan
- Ed Goldman, J.D., Medical Center Attorney, UMH Office of the General Counsel
- Jim Lepkowski, Ph.D., Associate Professor, Biostatistics, University of Michigan
- Roderick J. A. Little, Ph.D., Professor, Director, CRDSA Program, Biostatistics, University of Michigan
- Susan Murray, Sc.D., Associate Professor, Biostatistics, University of Michigan
- Trivellore Raghunathan, Ph.D., Professor, Biostatistics, University of Michigan, Senior Research Scientist, Survey Research Center
- Patricia A. Wren, Ph.D., M.P.H., Assistant Research Scientist, Health Behavior/Health Education, University of Michigan
- Gregory Saltzman, Ph.D., Adjunct Research Scientist, Institute of Labor and Industrial Relations, University of Michigan.
Professor in economics and management at Albion College
- Aruna Sarma, Ph.D., M.H.A, Assistant Research Scientist, Urology; Assistant Research Scientist, Epidemiology, University of Michigan
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