Courses and Seminars
CLINICAL RESEARCH MONTHLY SEMINAR
“Recruitment and Retention of Clinical Research Subjects”
Date/Time: Wednesday, December 17, 2003 12-1pm
Location: Evans Biomedical 650 Albany Street Room 714
Contact: Lori Gilmartin at logilmar@bu.edu
UNDERGRADUATE COURSES
FOR SPRING 2004:
GMS BT 440 OL Genetics, Ethics,
and the Law
GMS BT 452 Presenting Data in Biomedicine
GMS BT 531 Clinical Trials Management
GRADUATE COURSES FOR
SPRING 2004:
GMS CI 631 Clinical Trials Management
GMS CI 640 OL - Regulatory and Compliance Issues
SPH BS 722 Design and Conduct of Clinical Trials
SPH BS 820 Logistic Regression and Survival Analysis
SPH BS 852 Statistical Methods in Epidemiology
SPH BS 857 Analysis of Correlated Data
SPH EP 751 Cardiovascular Epidemiology
SPH EP 755 Infectious Disease Epidemiology
SPH EP 763 Genetic Epidemiology
SPH EP 915 Research Methodology and Medical Literature
SPH HS 811 Health Services Research Methods
SPH HS 815 Statistical Methods for Health Services Research
UNDERGRADUATE
COURSE DESCRIPTIONS:
GMS BT 440 OL Genetics, Ethics, and the Law
This class will explore the newest information in human genetics and
its legal and bioethical implications. Human genetics is the most explosive
field in medicine today and its present and future involve legal and
ethical decisions only imagined today. The decisions that come from
the issues will be presented to professionals and lay people alike.
Using audio-visuals, actual cases, discussion and lecture, this class
examines cases that come straight from the headlines. Topics covered
include: new reproductive techniques, genetic diseases, prenatal testing
and genetic testing, DNA fingerprinting, cloning, and DNA technology.
Yashon. Arranged. Top
GMS BT 452 Presenting Data in Biomedicine
This course surveys how personal computers
and on-line computing resources can be used as communication tools in
medical/biotechnical research
environments. Topics will include: communications design; acquisition
of experimental data; presentation of experimental data; on-line
resources at Boston University; and using the Internet and World
Wide Web as
research tools. Abruzzese. Wed 5:30-8:30pm. Top
GMS BT 531 Clinical Trials Management
This course is an integrative learning experience, combining a comprehensive
review of the good clinical practice core principles with explanation
and analysis of selected portions of the Code of Federal Regulations
(CFR), applicable to clinical research during the new drug development
process. The case study approach is used in this course since the drug
development industry translates these regulations into both written
and unwritten standards, practices, and guidelines. Each session will
use activities to expand the interpretation of the regulations, further
integrating real-life issues into the classroom.
Halloran. Mon 5:30-8:30pm.
For more information on these courses contact:
Connie Phillips
Phone: 617-638-5622
Email: cphilli@bu.edu
www.bu.edu/met/programs/undergraduate/certificate/clinical-research/index.html
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GRADUATE COURSE DESCRIPTIONS:
GMS CI 631 Clinical Trials Management
Preq: GMS CI 675 Design and Conduct and consent of instructor. This course
is an integrative learning experience, combining a comprehensive review
of the good clinical practice core principles with explanation and
analysis of selected portions of the Code of Federal Regulations (CFR),
applicable to clinical research during the new drug development process.
The case study approach is used in this course since the drug development
industry translates these regulations into both written and unwritten
standards, practices, and guidelines. Each session will use activities
to expand the interpretation of the regulations, further integrating
real-life issues into the classroom. In order to ensure that classroom
learning is linked with the students' work experiences, there will
be an outside project required which will incorporate the course work
with the on-the-job situations, and a final presentation to share the
learning with the entire class. Halloran. Mon 5:30-8:30pm. Top
GMS CI 640 OL - Regulatory and Compliance Issues
Prereq: Premedical course requirements and consent of instructor. Course
explains the regulatory requirements for healthcare products, that
is, drugs, biologics, diagnostics, and devices. Intended for those
interested
in regulatory affairs or in the clinical evaluation, development,
manufacture, testing and/or commercialization of these products.
An in-depth review
will be provided of the pertinent FDA regulations and guidelines
and links these to the scientific and logistical activities involved
in
taking a product from research to market. Content and preparation
of regulatory
submissions, including an Investigational New Drug Application (IND),
an Investigational Device Exemption (IDE), a New Drug Application
(NDA),
a Biologic License Application (BLA), a Pre-Market Approval Application
(PMA), and a 510K PreMarket Notification are described. International
requirements for health care products are also reviewed. Gloff. Arranged.
For more information on these courses contact:
Division of Graduate Medical Sciences
Phone: 617-638-5121
Email: natashah@bu.edu
www.bumc.bu.edu/gms
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SPH BS 722 Design and Conduct of Clinical Trials
This course covers the development, conduct, and interpretation of
clinical trials. It is suitable for concentrators in any department.
Topics include
principles and practical features such as choice of experimental design,
choice of controls, sample size determination, adverse event monitoring,
research ethics, informed consent, data management, and statistical
analysis issues. Students write a clinical trial protocol during
the semester.
Prerequisite - The epidemiology and biostatistics MPH core requirements.
Credits - 4 Top
SPH BS 820 Logistic Regression and Survival Analysis
This course provides basic knowledge of logistic regression and analysis
of survival data. The logistic regression segment focuses on prediction
of categorical outcomes. The segment on analysis of survival data concentrates
on comparing and predicting time-to-event outcomes. Both sections emphasize
the use of maximum likelihood to determine estimates and test hypotheses,
use of descriptive and diagnostic plots, and use of the SAS statistical
package to perform analyses.
Prerequisite - The biostatistics MPH core requirement and BS723. Credits
- 4 Top
SPH BS 852 Statistical Methods in Epidemiology
This course covers study design and intermediate-level data analysis
techniques for handling confounding in epidemiologic studies. Confounding
is carefully defined and distinguished from interaction. Course content
covers stratification and multivariable techniques for controlling
confounding in both matched and independent sample study designs, including
analysis of covariance, logistic regression, and proportional hazards
models. Students are required to apply these methods with the aid of
computerized statistical packages.
Prerequisite - SPH BS723, SPH BS703 and either SPH BS711 or SPH BS712
or consent of instructor (638-5172) Credits – 4 Top
SPH BS 857 Analysis of Correlated Data
The purpose of this advanced seminar is to present some of the modern
methods for analyzing correlated observations. Such data may arise
in longitudinal studies where repeated observations are collected on
study subjects or in studies in which there is a natural clustering
of observations, such as a multi-center study or observations clustered
within families. Students start with a review of methods for repeated
measures analysis of variance and proceed to more complicated study
designs. The course presents both likelihood-based methods and quasi-likelihood
methods. Marginal, random effects and transition models are discussed.
Students apply these methods in homework assignments and a project.
Prerequisite - SPH BS852 and SPH BS805 (or the equivalent as determined
by the instructor) Credits – 4 Top
SPH EP 751 Cardiovascular Epidemiology
This course introduces students to the epidemiology of cardiovascular
diseases, including hypertension, coronary heart disease, and stroke.
It focuses on the principal causes of cardiovascular diseases, particularly
those that can be modified to effect either primary or secondary prevention.
Extensive data on cardiovascular disease epidemiology gleaned from
the Framingham Heart Study are presented by senior investigators from
that study.
Prerequisite - The epidemiology MPH core requirement. Credits – 4 Top
SPH EP 755 Infectious Disease Epidemiology
This course presents the methods of studying common infectious diseases
in populations. It includes the determinants of these diseases, their
distribution within populations, and their control. There are lecture
presentations regarding specific diseases and agents. Implications
for social policy and preventive approaches are discussed. Analysis
of actual infectious disease outbreaks with classroom discussion of
prepared homework is included.
Prerequisite - The epidemiology MPH core requirement. Credits – 4 Top
SPH EP 763 Genetic Epidemiology
This course familiarizes students with general methods and principles
of genetic epidemiology. Topics include basic human genetics, population
genetics, pedigree analysis, linkage analysis in humans, twin studies,
effects of inbreeding, genetics of common diseases, population-based
studies of birth defects and chromosome abnormalities, and forensic
genetics. The course emphasizes practical applications of existing
methods to designing and executing genetic studies and to genetic counseling.
This involves some critical evaluation of the scientific literature.
Prerequisite - The epidemiology and biostatistics MPH core requirements
or consent of the instructor (638-5393) Credits – 4 Top
SPH EP 915 Research Methodology and Medical Literature
This course provides the student with a rigorous approach to critical
reading of the medical literature. Each week articles reporting on
research using varied designs and methods are reviewed in order to
illustrate the application of epidemiologic principles. By the end
of the course, the student is able to critique an article and identify
its strengths and weaknesses.
Prerequisite - Epidemiology and biostatistics MPH core requirements.
Credits – 2 Top
SPH HS 811 Health Services Research Methods
This course emphasizes an application-oriented approach to the study
of health services research with the goal of informing health care
policy. Emphasis is on the definition of the problem, scale of the
study, research methods, and analysis. A foundation is covered among
the following possible areas: measurement issues (reliability and validity),
secondary data analysis, clinical trials, sampling, survey methods,
qualitative methods, and economics (cost-effectiveness). Examples are
given from contemporary studies.
Prerequisite - The epidemiology and biostatistics MPH core requirements
and SPH HS702. Credits – 4 Top
SPH HS 815 Statistical Methods for Health Services Research
Competence in applied statistical methods and concepts is becoming increasingly
important to health service researchers. Because the conclusions and
recommendations stemming from health studies rely so heavily on the
results of proper data collection and their appropriate statistical
analysis, a working knowledge of health services statistics is one
of the most useful tools a health researcher can acquire. This course
is designed to provide students with such a competence. The course
is structured so that students will first learn important issues in
study design, and then learn statistical methods for these designs
that are commonly used in health services research. The course will
also make use of the statistics package, Stata, a popular statistics
package that is easy to use but powerful enough to perform all the
methods taught in the course.
Prerequisite - SPH HS814 and SPH BS703 Biostatistics (or equivalent).
Credits – 4 Top
For more information on these courses contact:
School of Public Health
Phone: 617-638-4640
Email: sphadmis@bu.edu
www.bumc.bu.edu/sph/index.htm
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