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.
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