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Department of Biostatistics

Clinical Research Design and Statistical Analysis (M.S.) Course Descriptions

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.

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.

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.

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.

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.

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.

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/EPID 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.

BIOS/EPID 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.

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.

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.

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.

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.