Courses Descriptions 

Advanced Molecular Genetics I:  Gene Regulation           26-MG-710               4 credits
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.


Advanced Statistical Methods in Biomedical Research   26-BE-864                3 credits
The course examines hidden markov chains; survival analysis; meta-analysis; longitudinal studies; comparison of populations; electronic noses; medical diagnostics.


Applied Longitudinal Analysis                                               26-BE-762                3 credits
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.

Applied Multivariate Analysis                                               26-BE-799                3 credits
The class introduces the extension of the use of univariate tests in normal populations to the multivariate case with a review of matrix algebra, single group multivariate methods; multivariate ANOVA; multivariate multiple regression; path analysis; principal components analysis; canonical
correlation; discriminant analysis; and exploratory and confirmatory factor analytic techniques.

Biological Therapies                                                                                                  3 credits
The new Biological Therapies course will utilize a number of faculty who have an exceptional amount of experience in conducting translational research trials.  Topics to be covered include:  1) gene and cell therapy:  NIH recombinant DNA guidelines, Appendix M, and the Recombinant DNA Advisory Committee; 2) surrogate outcomes; 3) pilot studies and Phase I trial design in human patients (vs. normal subjects); 4) vaccine trials; 5) local and national funding mechanisms for translational research; 6) repositories and cores; 7) the regulatory affairs alphabet soup:  IBC, SAC, IRB, FDA; and 8) risk vs. benefit issues of early phase trials in children vs. adults.

Biology of Cancer                                                                    26-CB-880               3 credits
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. 

Categorical Data Analysis                                                     26-BE-797                3 credits
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                                    26-BE-XXX               3 credits
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.

Clinical Trials Design and Research I                                   25-PHDD-605          3 credits
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.

Clinical Trials Design and Research II                                 25-PHDD-XXX         3 credits
This 2^nd year 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.

Clinical Trials Design and Research III                                25-PHDD-XXX        3 credits
This course covers both Phase IIIa and Phase IIIb studies.  For Phase IIIa studies, students will learn about trials in specific subject populations and the effects of covariates such as age, gender, and disease stage.  The use of surrogate end points and clinical go/no-go milestones will be discussed.  Instructors will cover how one determines final formulations, doses, and indications for drugs.

Decision Analysis and Cost-Effectiveness Analysis         26-BE-768              3 credits
This new 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 26-BE-975               3 credits
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             26-BE-828/829/830   1 credit
(3 credits required)
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                                                         26-BE-898               3 credits
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                         26-BE-897               3 credits
An introduction to epidemiology of the major cardiovascular diseases with a focus on risk factors.

Epidemiology of Infectious Diseases                                  26-BE-784               3 credits
The course covers the epidemiologic, serologic, and public health aspects of modern infectious diseases, their transmission, and methods of control.

Ethics in Research                                                                   26-GNTD-730          1 credit
This is a seminar that discusses the ethical issues in clinical research.  The grading is P/F based upon attendance.

Experimental Design                                                              26-BE-789                4 credits
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.

Genetics of Complex Diseases                                             26-BE-868               3 credits
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.

Global Drug Development: Opportunities and Challenges                                3 credits
Topics in this general overview of drug development will include the function and structure of the FDA; intellectual property; patents; and competitive market analysis, which drives the identification of new therapeutic targets, new molecular entities, formulations/drug delivery systems, and devices.  Students will learn traditional vs. contemporary (computational approaches and high-throughput screening) of target and ligand identification with regards to biologics, genomics, and chemicals.  FDA initiatives for accelerating drug development and examples of drugs approved under fast-track designation will be discussed.  Course instructors will include Jane Henney, MD, currently Senior Vice President and Provost for Health Affairs at UC and formerly Commissioner of the FDA.

Health Informatics                                                                  26-BE-XXX              3 credits
This new 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.

Health Services Research                                                     26-BE-XXX               3 credits
This new 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                                                                      35-GC-881               3 credits
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                                                 26-BE-787               4 credits
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                                               26-BE-776               3 credits
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 Molecular Genetics                                     26-GNTD-871          4 credits
This new 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                                       26-BE-778               2 credits
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.

Introduction to Techniques in Health Survey Research  26-BE-XXX              3 credits
In this new course, students will learn concepts, methods, and practical procedures for locating, evaluating, and implementing health survey instruments to answer their own research questions.  Through hands-on learning, students will gain experience in questionnaire design and construction, sampling considerations, questionnaire administration, coding, processing (including automated methods), presentation, and evaluation of results.  In addition, they will be introduced to scale construction.  Methods for testing psychometric properties of instruments and scaling methodologies used in research will be discussed.


Logistic Regression and Log-Linear Models                      26-BE-871                3 credits
This course covers analysis of discrete data using log-linear and logistic models, including interpretation of coefficients and model-building strategies.  Familiarity with SAS software through examples will be emphasized.


Meta-Analysis                                                                         26-BE-961                3 credits
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   
                                                                                                    26-BE-973               3 credits
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                                                               26-BE-842                 3 credits
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.


Patient Specimen Methods                                                                                       2 credits
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                                          26-BE-763                3 credits
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                                                  26-BE-766               3 credits
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                         26-BE-XXX               3 credits
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                                                               26-BE-788                4 credits
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.
 

Regulatory Affairs I: Pre-Clinical/IND                                 25-PHDD-602           3 credits
Principles and regulatory guidelines for pre-clinical evaluation of the pharmacol­ogy, toxicology and pharmacokinetics of investigational drugs and biologics and key elements of the Investigational Drug (IND) applica­tion and Clinical Investigators brochures.
 

Regulatory Affairs II: US Clinical                                          25-PHDD-XXX          3 credits
This course will cover ethics in clinical research; Good Clinical Practices; International Conference on Harmonization guidelines on global drug development; IRBs; informed consent; inclusion and exclusion criteria; participation of minorities, women, and children in research; HIPAA; and the differences between regulations and guidelines.
 

Regulatory Affairs III: Drug Delivery Systems/Devices  25-PHDD-XXX         3 credits
This 2^nd year course will cover biopharmaceutical and pharmacokinetic specifications for novel drug delivery systems/devices, development of drug delivery systems/devices, regulatory affairs, pre-clinical and clinical evaluation strategies, and clinical supplies manufacturing.

Regulatory Affairs IV: Approval, Pharmacovigilence, and Post-Marketing Surveillance
                                                                                                   25-PHDD-XXX           3 credits
This course will focus on pharmacovigilence, drug safety management, new drug application filing and approval, packaging and labeling, and Phase IV studies.


Research Lab Rotation                                                           26-ENV-891             1-3 credits
Molecular Epidemiology students take at least 1 credit hour for 2 quarters


Seminar in Outcomes Research                                                                              1 credit
This seminar will convert the existing Outcomes Research Conference from an approximately every-other-Friday schedule to an every-Friday schedule.  Faculty, students, and invited speakers from other institutions will present work in progress in the area of outcomes research.  Students will be exposed to a variety of research projects and to a variety of research designs and analytic strategies.  Each presentation will be followed by a short summary by a faculty member who will highlight methodologic and clinical issues pertinent to that presentation.  Some sessions will be devoted to rehearsing abstracts for national meetings.  To obtain course credit, students will be required to attend at least 80% of the sessions and present their research at least once a year.


Statistical Genetics I:  Principles and Methods                 26-BE-764                3 credits
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.


Statistical Genetics II:  Segregation & Linkage Analysis 26-BE-765               3 credits
This course covers advanced problems inherent in linkage and segregation analysis for quantitative traits, inbreeding and cross-breeding, and other related topics.  In addition, complex segregation analysis for qualitative as well as quantitative traits, including an introduction to different software for segregation analysis and interpretation of outputs from these various routines is covered.  Emerging issues related to gene localization and sampling design (simple gene, candidate gene, population versus family based designs, etc.) are covered. 


Structural Equation Modeling                                               26-BE-895                3 credits
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-869                3 credits
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.


Translational Research in Cardiology                                                                    1 credit
This course will review a number of exciting advances in understanding molecular pathways involved in cardiac disease – in particular in the response of cardiac muscle cell signaling in the acute care setting.  Issues unique to conducting translational research during cardiac surgery and the immediate postoperative period will be addressed.


Translational Research in Hematology/Oncology                                              1 credit
Emerging therapies currently in early phase clinical trials will be selected for discussion from a large portfolio of targeted therapies.  Topics will range from monoclonal antibody therapy to tyrosine kinase inhibitors and oncolytic viruses.


Translational Research in Immunology/Rheumatology                                    1 credit
Experience and lessons learned in developing and testing novel therapies for immunologic and rheumatologic diseases will be reviewed.  Recent clinical successes, such as various monoclonal antibody therapies, will be used as examples.


Translational Research in Pulmonology/Neonatology                                       1 credit
Successes and failures in translational research, such as gene therapy for cystic fibrosis, will be reviewed, as will difficulties associated with translational trials in premature infants.

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