Clinical Research

For course descriptions not found in the 2006-2007 General Catalog, please contact the department for more information.

CLRE 250. Patient-Oriented Research I (2)   This course will develop and apply the theory of clinical trials design and analysis, discuss the practical issues of financing and implementing clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present to a group of peers a concept sheet for a phase I/II and phase II/III clinical trial.

CLRE 251. Epidemiology I (2)   Scholars will recognize and understand different types of study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation.

CLRE 252. Health Services Research (2)   Scholars will evaluate relevant outcomes in patient-oriented research from the patient (quality of life) and societal (economic) perspectives and locate potential resources for assessing the relevant outcomes in a wide variety of study designs. They will also be able to describe the relative strengths of different health services research approaches to a clinical problem. Finally, they will understand the components of clinical practice guidelines, including patient preferences, and how these guidelines both depend upon as well as inform patient-oriented research.

CLRE 253. Biostatistics I (2)   Scholars will understand principles of measurement of clinical data, recognize data types, and correctly identify statistical methods appropriate for analysis of a given clinical data set. They will gain experience in assembling a clinical dataset in formats suitable for analysis by STATA or other comparable statistical packages. They will learn skills to conduct graphical and numerical exploratory data analysis, comparative tests of categorical, ordinal, and continuous data, linear and logistic regression analysis, and survival analysis by life table and Kaplan-Meier techniques.

CLRE 254. Biostatistics II (2)   Scholars will understand and conduct advanced biostatistical analyses including: multiple linear and logistic regression, survival analysis, and Cox and extended Cox regression. The scholar will also be familiar with person-time rate analysis with Poisson regression and longitudinal data analysis in the presence of missing values and varying measurement times. Prerequisites: Biostatistics I, CLRE 253.

CLRE 255. Data Management and Informatics (2)   This course provides an orientation to database design and management and covers key issues regarding data handling for clinical research and clinical trials. Scholars will also become familiar with technology assessment and decision-making methods and analysis.

CLRE 256. Patient-Oriented Research II   This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to an IRB for peer review and practice presenting graphic and tabular data. Prerequisite: Patient-Oriented Research I, CLRE 250.

CLRE 257. Epidemiology II (2)   Scholars will select the appropriate sampling method and determine the sample size necessary for specific projects and adjust for confounding. Participants will be familiar with several specialized analytic techniques, including matched, cluster, and meta-analyses. They will also be familiar with methodological issues, unique to ecological, behavioral, and genetic studies. Prerequisite: Epidemiology I, CLRE 251.

CLRE 296. Independent Study Project (6)   The Independent Study Project (ISP) is the cornerstone of the MAS program. Students will be involved in a high-level clinical research projet that integrates what they have learned in their formal course work. The ISP will be an independent and creative scholarly activity in an area related to one or more of the topics covered in the formal curriculum. Students' work will be evaluated by a committee of faculty, and, in some cases, industry advisers.