Clinical Research Design and Statistical Analysis (M.S.)
The Clinical Research Design and Statistical Analysis program (OJOC CRDSA) is accepting applications for the fall 2015 on a rolling basis.
Offered by the Department of Biostatistics, the On-Job/On-Campus Master's in Clinical Research Design and Statistical Analysis (CRDSA) Program was developed in a non-residential format to provide a means for working professionals who are interested in clinical research to develop expertise in research design and statistical analysis while continuing their professional employment. The program is open to a broad spectrum of candidates such as physicians, dentists, pharmacists, pharmacologists, basic scientists, study coordinators, managers and others who are interested in pursuing a career in Clinical Research and Clinical Trials.
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 quantitative research methods. These problems reflect the increasing complexity of clinical research, the increasing value of that clinical research, and the limited training of health professionals in research design and statistical analysis. Most clinical training programs include only minimal introductory statistics and research design activities. This CRDSA program is designed specifically to teach the skills and knowledge needed to carry out quantitative clinical research.
The U-M 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 nineteen weekends.
Future Program Dates
October 2015–April 2017
Integration with Employment
Each student's work setting becomes 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 isolated from, practice.
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, the 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 are presented, including comparison of proportions, chi-square test, comparison of means, analysis of variance and covariance, multiple regression analysis, logistic regression, and survival analysis.
In addition to a comprehensive curriculum in research design and statistical analysis, other content relevant to clinical researchers includes: 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.
- BIOS 511: Computer Packages
An introduction to statistical computer packages in both network and microcomputer environments. Data organization and file management will also be discussed. Syllabus
- BIOS 517: Survey Sampling for Clinical Research
The main sampling methods used for surveys in clinical research are discussed, including: probability sampling; simple random sampling; stratified sampling; systematic sampling; multi-stage sampling; sampling with probability proportional to size; cost factors; sampling errors; non-response; sampling frame problems; non-sampling errors; practical designs and procedures. Syllabus
- BIOS 524: Biostatistics for Clinical Researchers
Basic probability theory and statistical methods used by biostatisticians. These include design of experiments, point and interval estimation, and hypothesis testing. New topics include simple and multiple regression methods, and analysis of variance and covariance. Syllabus
- BIOS 560: Statistical Methods for Epidemiology
Statistical methods commonly used in clinical research, with an emphasis on choosing appropriate procedures and subsequent interpretation. Topics covered: 2 x 2 tables, Mantel-Haenszel, tests for trend in risk, methods for matched designs, logistic regression, and Cox models. Syllabus
- BIOS 581: Biostatistical Modeling in Clinical Research
This is a course in statistical modeling, with an emphasis on models for correlated data that arise when subjects are repeatedly measured or are clustered. These models, called mixed models, are extensions of linear and nonlinear regression and analysis of variance. Examples will be drawn from clinical studies, such as multi-arm biomarker studies and crossover trials. Analyses of population pharmacokinetics and longitudinal data will also be discussed. Hands-on data analysis and presentation using standard computer software for linear and nonlinear analysis will be emphasized. Course goals include the ability to formulate and evaluate a model, to read the scientific literature that employs these models, to interact fruitfully with data modeling specialists, and to present the results of these models mathematically and graphically. Syllabus
- BIOS 590: Statistical Analysis and Presentation of Research Topics
This course is intended to integrate and apply biostatistical and epidemiologic methods presented in other OJ/OC courses to clinical research data. Students will identify the scientific objectives of a clinical research study and develop a statistical analysis strategy appropriate for those objectives; plan strategies for statistical design and analysis and implement these strategies; learn to be aware of problems that arise in data collection; learn to communicate through presentation of oral and written reports and through student and faculty critiques of these reports; learn to communicate results of clinical research projects in clear, accurate, concise language; learn appropriate writing styles and formats for clinical research articles, and apply writing skills to research papers. Syllabus
- INTMED 606: Clinical and Translational Research Seminar
A series of seminars that illustrate the definitions, functions and utility of clinical research, design of clinical research, and the application of statistics to clinical research through the medium of visiting faculty experienced in clinical research.
- BIOS 558: Clinical Trials and Study Design
A review of the ways clinical trials are used as a research tool: design of clinical trials; randomization; sample size; compliance; blinding; analysis of clinical trials data; stopping rules. The course also considers advantages and limitations of alternative types of quasi-experimental designs; nonequivalent control group designs; interrupted time-series designs; case series; crossover designs; meta-analysis. Syllabus
- BIOS 599: Planning and Funding Clinical Research
This course will encompass four main areas of exploration. The preparation of a written document whose focus is on an integrated research plan including specific aims, background and significance, design, methods, logistical implementation and statistical analysis, and fiscal requirements. The evaluation of clinical research plans. Identification of funding sources and their requirements. And identification of the role of the research administrator in facilitating clinical research. Syllabus
- EPID 601 : Methods of Epidemiology: Measure and Measurement
An overview and introduction to the measure of association used in epidemiologic studies, as well as a description of the nature and characteristics of major epidemiologic study designs. Syllabus
- HBHE 531: Psychosocial Aspects of Research: Data Collection and Threats to Validity
Conceptual and operational issues in psy-chosocial research are discussed. Topics include: quality of life measurement, models of health decision making, measuring attitudes and beliefs, and behavioral threats to validity such as patient adherence and patient-provider relationships. Designing a survey instrument, writing items, and selecting a method of data collection will also be emphasized. Syllabus
- HMP 540: Legal Rules and Ethical Issues for Clinical Research
The course is organized in two parts: Part I studies the history of research regulations, requirements for ethical research, informed consent, institutional review boards, protection of special at-risk populations, deception in research, and future directions of regulations on research. Each participant presents a research design and the class analyzes its legal aspects. Part II is a series of lecture discussions on current ethical issues in clinical research. Syllabus
- HMP 542: Cost Utility Analysis and Clinical Research
Economic issues and analytical techniques relevant to the performance and evaluation of clinical research are investigated. Special emphasis is placed on the theory, practice, usefulness and limitations of cost-benefit and cost-effectiveness analysis. Syllabus
The M.S. in CRDSA is administered through the Horace H. Rackham School of Graduate Studies. To apply for the CRDSA program please fill out a Rackham Graduate School application. All applicants should document their current or potential involvement in research including 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 three areas are strongly encouraged to take the GRE) or a transcript showing coursework and grades of B+ or better in two or more college-level mathematics or statistics courses will generally be sufficient. Information on the GRE is available either by phone at 1-800-GRE-CALL or visit the GRE Website
The applicants to the CRDSA program must submit the following supplemental materials (online) in addition to a complete Rackham Application and non-refundable application fee:
- Official transcripts of all college-level education (upload copy and/or mail original with application).
- Three letters of recommendation (your recommenders submit them online).
- Statement of Purpose (submit online with application).
- Personal Statement (submit online with application).
- Curriculum Vitae (submit online with application).
- 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 can also be mailed to:
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: firstname.lastname@example.org
Tuition and Funding
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).
- Mousumi Banerjee, Ph.D., Research Professor, Biostatistics, University of Michigan
- Brenda Gillespie, Ph.D., Research Associate Professor, Biostatistics, University of Michigan
- Ed Goldman, J.D., Medical Center Attorney, UMHS Office of the General Counsel
- Susan Goold, M.D., M.H.S.A., M.A., Professor of Internal Medicine, Medical School, Professor of Health Management and Policy, School of Public Health, University of Michigan
- Jim Lepkowski, Ph.D., Professor, 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., Associate Professor and Program Director, Health Sciences, Oakland University
- 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, Research Assistant Professor, Urology; Assistant Research Scientist, Epidemiology, Adjunct Lecturer, Epidemiology University of Michigan
- Anca Tilea, M.P.H., Research Area Specialist Senior, Biostatistics, University of Michigan
Telephone: (734) 615-9812
Department of Biostatistics
OJ/OC Program in CRDSA
School of Public Health
University of Michigan
1415 Washington Heights
Ann Arbor, MI 48109-2029
Fax: (734) 763-2215
Mentored Clinical Research Course
The Michigan Institute for Clinical and Health Research (MICHR) provides a 6-credit mentored clinical research course to interested students accepted to the OJ/OC program who demonstrate commitment to research. A mentor team guides the student through a clinical research project designed by the student with the goal of generating pilot data for a clinical research grant proposal. Students showcase their work at the MICHR Annual Symposium and have access to research resources and consultation. Through this program, trainees will gain valuable career development mentoring and:
- Employ biostatistical skills and knowledge in specific areas of clinical research
- Design a clinical research study
- Follow requirements for human subject protection, ethical principles, and research integrity essential for the conduct of human subject research
- Develop specific aims and the framework for a grant application to an appropriate funding source
NOTE: This course is available only to professionals affiliated with the University of Michigan.