Course Descriptions

This list of elective courses is non-exhaustive, and intended only as a suggestion of courses that may be of interest. Trainees may select any course offered within the program as elective courses. Course ratings were derived from 2009-2010 student evaluations.

Course Title

Course Number

Credit Hours

 

Advanced Biostatistics BE-7023 3  
The role of regression in all its diversity in data analysis. This is purely an applied class with examples culled from a variety of sources. The software R will be used for all computational needs.
       
Advanced Statistical Methods in Biomedical Research BE-8064C 2  
The course examines hidden markov chains; survival analysis; meta-analysis; longitudinal studies; comparison of populations; electronic noses; medical diagnostics.
 
Analysis of Internet Health Data BE-7080 3  
The course examines sampling techniques and data analyses useful in analyzing a variety of internet health data sets. Students choose a health data set and are guided through data analysis to help produce a paper for publication.
       
Applied Longitudinal Data Analysis BE-7062 2  
Statistical methods for analyzing multivariate normal data, focusing on data collected in the form of repeated measurements. Multivariate normal distribution, Hoelling’s T2, multivariate analysis of variance, repeated measures analysis of variance, growth curve models, mixed effects models. Implementation with SAS software PROC GLM and PROC MIXED is provided in detail.
       
Biology of Cancer CB-8080 3  
Currently, a one quarter course that covers a broad spectrum of issues relating to the genesis and progression of cancer. Some topics that are covered include cell kinetics and cell cycle regulation in normal and cancerous cells, onco­-genes and growth factors, tumor suppressors, the genetics of cancer, mutation and environmental exposure, signal transduction and the role of the immune system in cancer.
       
Biostatistics in Research BE-7061 3  
Seminars or tutorial sessions dealing with special topics in biostatistics related to research and application basic to field of environmental health.
       
Categorical Data Analysis 26-BE-797 3  
Statistical models and methods for categorical responses including logistic regression. Chi-square test, Fisher’s exact test, McNemar’s test, Mantel-Haenszel test sensitivity and specificity, odd ration, and relative risk. Some discussion of software and implementation of methods and usage including sample size and power issues in analysis of categorical data.
       
Clinical Research Scholars Seminar BE-9066 1  
This monthly seminar has four objectives: 1) to cover topics not typically covered in most courses, such as how to write papers, hot to write grants, how to present research, and how to negotiate for jobs; 2) to allow students form all tracks to see and critique each others’ research-in-progress presentations; 3) to enable students to meet with various cutting-edge clinical researchers; and 4) to foster further interaction among Dr. Tsevat, Dr. Daniels, and other students in the clinical research training program. The seminar will meet monthly for 3 quarters for 1 hour.
       
Phase I/II Clinical Trials Research and Design PHDD-8050 3  
Regulatory, statistical and operational issues in phase I trials will be discussed. The use of first dose in humans, dose escalation schemes, determination of maximal tolerated dose, mass balance, metabolism and bioavail­ability will be covered along with drug-drug interaction and food-ef­fect.
       
Phase III/IV Clinical Trials and Research PHDD-8060 3  
This 2nd course covers Phase IIa studies of efficacy and short-term safety in patients and Phase IIb studies of efficacy, side effects, and clinical toxicity in controlled trials. Key elements of Phase II studies addressed are crossover, parallel studies, withdrawal, single group studies, and factorial designs. Go/no-go decision points and dose selection for phase III studies will be addressed. Other topics will include parallel formulation development and clinical supplies.
       
Community-Based Participatory Research BE-8063 1-3  
This class is designed to familiarize learners with the theoretical framework, methodologies, and applications of community-based participatory research and how it differs from traditional research approaches and community-placed research. The class will emphasize how to apply such methodology to complex health and socio-cultural problems.
       
Computational Statistics BE-7024 3  
Using R and SAS software in basic PROC procedures, simulations, and advanced statistical methods.
       
Decision Analysis and Cost-Effectiveness Analysis BE-7068 3  
This course will introduce participants to the methods and applications of decision analysis, cost-effectiveness analysis, and cost-benefit analysis in medical decision making. Topics will include Bayes’ theorem and evaluation of diagnostic tests, the design and interpretation of decision trees, sensitivity analysis, Markov models, utility assessment, and economic analysis of healthcare programs. Examples will be drawn from both the individual patient and health policy perspectives. Students will learn how to use decision analysis software.
       
Design & Management of Field Studies in Epidemiology BE-9075 3  
Opportunity to acquire knowledge and skills in many aspects of the designs and conduct of field based research. Includes writing a hypothesis and writing a research proposal or grant application, designing questionnaires, survey sampling, sample size determination and the art of presenting results and evaluating research.
       
Epidemiology and Biostatistics Division Seminar (2 credits required) BE-8028/8029 1  
This weekly seminar features faculty from the Division of Epidemiology and Biostatistics, advanced students, epidemiologists, biostatisticians, and other persons from public and private institutions. The seminar offers a forum to learn about ongoing faculty research and provides an opportunity for students working on their thesis or dissertation to gain experience in presenting findings and fielding questions from the audience. Nuts and bolts of research that are often not available in textbooks are discussed.
       
Epidemiology of Cancer BE-8098 2  
A general overview of known associations of environmental and occupational factors with various types of cancer; includes discussion of types of studies that give rise to associations and causation.
       
Epidemiology of Cardiovascular Diseases BE-8097 2  
An introduction to epidemiology of the major cardiovascular diseases with a focus on risk factors.
       
Epidemiology of Infectious Diseases BE-7084 2  
The course covers the epidemiologic, serologic, and public health aspects of modern infectious diseases, their transmission, and methods of control.
       
Ethics in Research BE-7067/
GNTD-7003
1  
This is a seminar that discusses the ethical issues in clinical research.
       
Experimental Design BE-7089 3  
This course covers the statistical basis for experimental designs and the analysis of experimental data. Designs that are discussed include the two-group independent and correlated design; completely randomized factorial design for more than 2 groups; nested and split plot models; repeat measure designs; complete and incomplete block designs and fractional factorial designs. Associated topics include tests for homogeneity of variance; power analysis; methods for performing multiple comparisons; fixed, random and mixed models; construction of an EMS table; and construction of proper (direct and pseudo-) F-ratios.
       
Gene Regulation MG-8001 3  
Provides a literature-based view of major research questions, with emphasis upon gene structure and the regulation of gene ex­pression. Student discussions are included with the lecture format.
       
Genetics of Complex Disease BE-8068 2  
This course will provide a broad overview of genetics of complex diseases and traits covering topics including epidemiology and genetic basis of complex diseases; methodological considerations in the study of complex diseases, viz., genetic heterogeneity, choice of population; analytical approaches, viz., linkage, association, linkage disequilibrium; molecular methods and tools.
       
Health Services Research BE-8067 2  
This course will address research on the effects of the organization, delivery, and financing of healthcare. Principles of health services research, including patterns of resource utilization, small area variation, medical errors, and measurement and improvement of quality of care will be emphasized. This course will introduce the diverse methods used in health services research and the basic methods of inference in such research. Health services research will be taught as an integrative activity that draws upon the knowledge and methods from a wide range of disciplines, including the behavioral and social sciences, biostatistics, epidemiology, health economics, health education, and operations research. The course will also introduce students to the following areas: understanding variation in the organization and financing of healthcare delivery; methodologies for measuring and predicting quality of care and health outcomes; assessing the impact of technology and treatments on patient outcomes; and assessing the impact of health policy on individuals and populations. The course will emphasize health services research methodology, including approaches to the analysis of large secondary databases from the National Center for Health Statistics, AHRQ, and elsewhere.
       
Human Genetics GC-7020 3  
Introduction to basic human genetics including mitosis, meiosis, chromosome structure and mechanisms of rearrangement, inheritance, modes / mechanisms, mutational mechanism, population / quantitative genetics and bio­chemical genetics (polymorphisms).
       
Introduction to Biostatistics BE-7022 3  
The course covers descriptive statistics, probability distributions, estimation, types of error, significance level, hypothesis tests, sample size, correlation, linear regression, non-parametric methods.
       
Introduction to Epidemiology BE-7076 2  
The course introduces methodology for studies of disease in human populations. Topics that are covered are chronic disease, infectious disease, and occupational and environmental epidemiology. Sources, collection, handling, and interpretation of health data are also discussed.
       
Introduction to Medical Informatics BE-8062 2  
This course will cover medical informatics and its relation to patient care, data extraction, databases, and clinical research. Evidence-based medicine and clinical effectiveness research will be highlighted in the discussions. Strengths and limitations of hardware, systems, and data will be discussed. Specific topics will include: common terms; security and confidentiality; general hardware information; general network architecture information; standards and identifiers; data entry methods; interfaces and data integrity; computer-based medical information systems; medical imaging systems; databases, data marts, and data warehouses; data mining and reporting; expert systems; the Internet and Intranet and healthcare; education and training technologies; the product evaluation process; vendor relationships; general financial information; and personal productivity applications. Learning objectives will be achieved using a variety of methods including: didactic lectures, demonstrations, self-study, and student projects.
       
Introduction to Multiple Testing Adjustment   3  
In medical research, we often find it is very difficult to replicate findings reported in the literature. The reasons for lack of replicability include false positive results, which can be caused by ignoring the issue of multiple testing. From this course, you will learn the methods to address the multiple testing issues and their applications in clinical trials and genetic epidemiology studies.
       
Molecular and Cell Biology   GNTD-7001 3  
This course is designed to give the student an opportunity to learn about new laboratory methodologies that are commonly used in epidemiology before entering their laboratory rotations. They will hear speakers discuss their laboratory technologies and the usefulness of those technologies when undertaking human research studies. This course will consist of both lecture and direct observation of the laboratory methodologies. The student will be provided with an overview of the various technologies including gene chip technologies, microarray methods, proteomics, bioinformatics and computational medicine approaches.
       
Introduction to SAS Programming BE-7078 1  
This course includes instruction in basic SAS programming. Manipulation of data to created data sets for analysis is emphasized. The use of procedures for display and organization of data are presented.
       
IRB Process & Protocol BE-7081 1  
This course gives students hands-on experience with preparing a human subject research study and submitting it to the Internal Review Board (IRB).
       


Leadership in Clinical and Translational Research
 

26-BE-9065



1-3
 
This course focuses on the managerial and leadership competencies required for clinical and translational research in Academic Health Centers. Each topic area will have a corresponding practice and application component, allowing learners to work with real projects and challenges. Leadership styles will be reviewed, including corresponding strategies to employ based on the style type and personal attribute inventory assessments. Individual contributor, team member and managerial roles in multi-disciplinary teams will be illustrated. Time and productivity strategies conducive to collaborative relationships and research teams will be reviewed, and active project management plans will be populated. Methods to identify mentors, be a good mentee, and serve as an effective mentor will be illustrated, and applied across the spectrum of relationships necessary to be effective in an Academic Health Center. Techniques to stimulate creative thinking and leverage innovation will be reviewed and applied. Methods and measurement of academic success, including evaluation, scholarly activity and productivity, and funding will be delineated.
       
Meta-Analysis BE-9061C 3  
Meta-Analysis is the systematic quantitative review of all research studies directed toward a particular scientific or policy question. This course will cover all aspects of this process, including searching and evaluating research reports, extracting data, computing measures of effect size for continuous and categorical data, estimation of statistical models using SAS and WinBUGS software, and preparation of a manuscript. Students will conduct a meta-analysis on a topic of their choice, subject to instructor approval.
       
Molecular Epidemiology – Use of Biomarkers in Epidemiologic Research BE-9073 2  
The course covers how biomarkers can be used in epidemiologic research; scientific, technical and ethical issues in the use of biomarkers and a range of applications for the use of biomarkers in the study of various diseases.
       
Neuroepidemiology BE-8042 2  
Neuroepidemiology is the investigation of the distribution and dynamics of neurological disease in free ranging human populations. This course explores the scope and methods of neuroepidemiology.
       
Nutritional Epidemiology BE-8063 3  
Introduction to the concepts of study design and analysis in nutritional epidemiology; review of the function of macronutrient and micronutrients; discussion of several specific diet-disease relationships discovered in large clinical trials and observational studies; integration of information from molecular epidemiology, cardiovascular epidemiology, and animal experiments. Strengths and weaknesses of previous epidemiologic studies on the associations between nutritional factors and chronic diseases. Students will have the opportunity to work on individual projects.
       
Occupational Epidemiology BE-8079 2  
Application of epidemiologic methods to the study of occupational exposure-disease relationships to facilitate comprehension of published epidemiologic literature and assist in the design and conduct of original research.
       
Patient Specimen Methods BE-7069 1  
A critical component of translational research is to use human subject specimens to drive laboratory research that may impact ongoing clinical research or lead to a new clinical trial. Therefore, it is essential for translational researchers to understand the steps required for collecting, handling, storing, and allocating patient material for study in a HIPAA-compliant fashion. This is a hands-on course in which students will spend time in the CCHMC Cell Processing Facility and the Translational Trials Development Support Laboratory. Practical knowledge of using the Web-based protocol manager and biologic sample tracking system developed at CCHMC will also be covered. Knowledge of how clinical material is handled will aid students in designing translational research trials.
       
Pediatric Environmental Health BE-7063 2  
Epidemiological and molecular methods for assessment of the impact of environmental chemical exposures on child health and development are surveyed. The health effects of prevalent environmental toxicants on neurodevelopment, pulmonary function, and cancer risk are explored in detail. Methods for evaluating primary and secondary prevention strategies are presented. This course is taught by several instructors who are recognized as international leaders in their particular fields of study.
       
Principles of Clinical Trials BE-7066 3  
This course will cover the scientific, regulatory, managerial, and dissemination aspects of clinical trials, including: types and quality of trial design; pros and cons of “experimental” vs. “management” trials; randomization (allocation ratio, stratification, block size) and how it addresses the issues of random and non-random error; rationale and implementation of masking strategies; sample size estimation; subject and clinician consent; Office for Human Research Protections regulations, FDA regulations and IRB proposal preparation; inclusion/exclusion criteria; safety monitoring, interim analysis, and reporting; implementation of single-center vs. multicenter trials; roles of research coordinators, nurses and technicians; data collection and reporting; creating a trial budget; writing a clinical trial grant proposal; attrition, including sample size and interpretation considerations; non-random distribution of risk in a randomized trial; reporting and interpreting results (risk ratio, odds ratio, risk difference, number-needed-to-treat, etc.); and use of computerized trial registries such as the Cochrane Collaboration. Analytic topics will include missing data, multiple comparisons, post hoc subgroup comparisons, survival analysis including Cox proportional hazards modeling, logistic modeling, log-rank tests, and meta-analysis of trials. Students will learn about innovative strategies to address common design problems including factorial design, consent by “opting in” vs. “opting out,” funnel plots, and trials designed to address the effectiveness of methods to disseminate new evidence to clinicians. Students will design a clinical trial in their own field of interest, to include preparation of a protocol and a critical review of the literature.
       
Quality Improvement and Patient Safety BE-7071 1  
This course will cover the fundamentals of quality improvement and patient safety. It will use a framework of human factors to facilitate understanding complex system failures and successful strategies to reduce hazard in industrial and medical environments. The concepts are taught using a case-based format to explore common human and organizational sources of failure, such as missing or inert knowledge, communication/collaboration, clumsy technology, human computer interaction (alerts and reminders), and role of a safety culture. The second half of the course is devoted to learning approaches for implementing evidenced-based practices based on Rogers’ theory, where adopting innovation in an organization is divided into two major activities: initiation and implementation.
       
Regression Analysis BE-7088 3  
The course covers the following topics: linear regression, least squares, multiple regression models, model diagnostics & building, correlation analysis, introductory analysis of variance and introductory logistic & Poisson regression models.
       
Special Topics   3  
Different topic each semester. Sample of past topics: Bagging and Boosting, Observational Studies, R Package, Genetics with R, Multivariate Analysis with R, Sample Size Calculation, Cluster and Data Analysis, Hidden Markov Models, Bayesian Analysis, Mixture Models, Multiple Testing Adjustment, Discrete Longitudinal Data Analysis, Mini Proposals, and other topics in Epidemiology. 
       
Statistical Genetics BE-7064C 3  
Course objectives are to learn how various genetic data are generated and analyzed and to understand the linkage hybridization between statistical genetics and molecular, genetic, and cancer epidemiology. Didactic lectures include application of statistical procedures in conducting population genetic analyses for localization of disease-susceptibility genes and estimation of genetic risks, including gene frequency estimation, detection and estimation of the extent of population substructure effects, measurement and estimation of genetic admixture proportions and the nature of discrete genetic data, application of the Hardy-Weinberg law, model-free measures of association, the likelihood method, and principles of genetic inference and segregation analysis.
 
       
Structural Equation Modeling BE-8094 2  
Path analysis, measurement error models; confirmatory factor analysis; general structural equation model with latent variables; alternative estimators and models for categorical data.
       
Study Design and Analysis 26-BE-8069 2  
This course builds upon the epidemiologic concepts covered in the Introduction to Epidemiology course. Clinical epidemiologic study designs are examined in more detail and variants of the basic designs are introduced. Nested case-control designs, clinical trials, matching, and innovations such as case-cohort and counter-matched designs are examined in depth. Biostatistical methods appropriate for each type of study design are described and quantitative examples provided. Two special computer lab sessions are included to give students hands-on experience using SAS to analyze clinical epidemiologic data.
       
Successful Scientific Writing BE-8075 1-2  
Students will learn to communicate the findings of their research and investigations more effectively, and expedite publication of their manuscripts.
       
Survey of Clinical & Translational Research BE-9070 1  
A general overview of a variety of topics in clinical research including interpreting regression and survival analysis, developing a successful relationship with a mentor,  and project management.
       
Quantitative and Qualitative Data Collection Methods for Health Services Research 26-BE-7070 2  
In this course, students will learn the fundamentals of quantitative and qualitative research methods as well as how to integrate the two approaches in a single research design. Students will design either a sequential or concurrent mixed methods study that combines survey research and qualitative methodology to answer their health-related research question. Students will acquire the following skills: defining a health-related research question, identifying constructs, selecting sampling and data collection strategies, designing survey instruments and qualitative question guides, and data analysis. Learning objectives will be achieved using didactic lectures, in-class activities and projects.


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