Coursework

Statistical issues of special pertinence for CTR. Topics include: probability distributions and conditional probability; descriptive statistics; statistical inference to include concepts of population, sample, parameter, point and confidence interval estimates, and hypothesis testing; contingency tables; parametric and non-parametric procedures for comparing single and multiple factor experimental groups; regression and correlation techniques including multiple regression and logistic regression; analysis of variance. In addition, issues relevant to the design of clinical research experiments is emphasized, particularly the use of randomization, blocking, stratification and adequate sample size. 

The course will cover a broad range of bioinformatics tools relevant to CTR. It will introduce the nature of high dimensional data generating from major research areas of concentrations: genomics, microarray, proteomics, and metabolomics. Topics include predictive model development, validation, assessment of misclassification error rates, cross-validation, multiple comparisons, false discovery rates, dimension reduction techniques, principal components, cluster analysis and discriminant analysis. Some lectures will be taught by faculty from the joint Emory-Georgia Tech Coulter BME Department, GT Bioengineering, and GT Center for Bioinformatics and Computational Biology in collaboration with Emory and MSM faculty. 

Fundamental and quantitative issues in clinical research and clinical trial design, including aspects of experimental design and analysis are covered in this course. Longitudinal data analytic techniques and time-to-event survival methods are emphasized. Power and sample size arguments using PASS software are covered as well. Major topics in clinical trial design are discussed and several recent trials conducted at Emory are highlighted. 

Analytic epidemiology is covered including approaches to studies of human population events with emphasis on hypothesis formulation; causal inference; measurement of disease occurrence and associations; study design (e.g. cohort, cross-sectional, case-control); sources of bias (e.g., selection and information bias); evaluation of random error (frequentist vs. Bayesian approach); detection of interaction and control of confounding variables. 

Laboratory component to complement BIOS 500M and EPI 530M. Focuses on management and analysis of clinical research data, using a programming approach in SAS software. Topics include data entry and manipulation, quality assurance in data management, and implementation of statistical methods learned in BIOS 500M. 

Continuation from analytic epidemiology and data management courses in the first semester. Aids students in developing analytic skills necessary to model data collected from experimental and observational studies in order to assess the role of multiple risk factors in association with disease outcome events. The goal is to provide a foundation for understanding the multivariable nature of human health events and develop the critical reasoning to apply these skills towards an overall analytic approach. 

Provides hands-on experience in the systematic analysis of collected data, using both univariable and multivariable approaches, including logistic and Cox models. Three studies are analyzed in this course: illustrating analysis for etiology and therapeutic intervention. The course also provides experience in presenting scientific data in text, tables and graphs. Bayesian clinical trial models are examined and Decision Analysis is covered in detail. The goal is for the student to reach a level of skill with data analysis adequate to begin and successfully complete the analysis of thesis research data. 

Explores the practical issues of clinical/translational research in a seminar setting; in addition, special emphasis is given to topics, procedures, and analytic techniques related to health services research, health economics, human genetics, and multidisciplinary research. 

Examines concepts inherent to the ethical and responsible conduct of clinical and translational research and covers a number of important human subjects research training issues for MSCR participants. Combines lectures and small group discussions of assigned readings and reflection papers. Topics include: overview of ethics and the history of the protection of human subjects; informed consent and vulnerable subjects; development of data and safety monitoring plans and data and safety monitoring board (DSMB) charters, conflicts of interest; IRBs, HIPAA, ethics of genetic testing and gene therapy, and ethical issues in research in the developing world. MSCR students are also required to complete the Emory IRB online Human Subjects Research Training course in their first semester. 

Develops writing skills for peer-reviewed publications and grants. Effective scientific communication and writing skills are reviewed, institutional routing, and the NIH grant review process. Assignments include queries of the CRISP database, hypothesis and specific aim development, critique of extant literature, presentation of pilot data, integration of research methodology with solutions for potential problems, construction of a grant budget and other critical documents including a data safety and monitoring plan, human subject protection and informed consent, letters of support and other appendix materials. Each student prepares a grant proposal for extramural funding which is critiqued by the course directors. Final product is a grant; the type of grant is tailored to what is appropriate for the particular trainee; for most this includes a K23 (or K08) application. In addition, we will provide a bank of previously funded NIH K series grants from Emory junior faculty to use as a guide and set up meetings between the course directors and trainees/mentors to evaluate progress and provide feedback. ACTSI investigators with a strong record can also be scheduled to provide direct, hands-on individual assistance for grant writing for junior faculty on a scheduled basis. 

All MSCR participants conduct a mentored thesis project in clinical or translational research (PhD graduate students will complete a PhD thesis on a CTR related topic in lieu of the master's thesis). Investigators serving as mentors should have a strong track record in federally-funded clinical and/or translational research, and provide a wide spectrum of research opportunities. Mentors must commit to the time and effort to effectively guide the students. A mentor is selected and a project outline is submitted to the RECTD Executive Committee upon application to the MSCR program. The thesis requires developing a hypothesis-driven research proposal to investigate a clinical/translational research question, followed by data collection, analysis of data and presentation of results (both oral and written in a format suitable for publication in the medical literature). It should incorporate appropriate procedures and skills learned in formal course work. The research thesis may focus on a therapeutic clinical trial, interventional study, observational study, an epidemiologic or molecular epidemiologic study, a clinical evaluation program (health services, outcomes, etc.) or a translational research project. Students provide an oral presentation to the RETCD Executive Committee and submit a written thesis, which must be approved by the MSCR program and Dean of the Graduate School of Arts and Sciences. A bound copy must be deposited with the Woodruff Library for open inspection. MSCR students are strongly encouraged to present their thesis data at a national meeting and publish their thesis data in a peer-reviewed journal. The data may also impact and serve as the foundation for a career development grant submitted to NIH (e.g. F32, K-series) or a foundation. 

Introduction to analytic medicine for clinical/translational researchers. This course attempts to correlate all the issues presented in greater detail in the rest of the curriculum. The course introduces protocol design, hypothesis development, the gathering of unbiased evidence, modeling and statistical inference including Bayesian inference. Decision analysis is introduced. Topics include design of clinical trials and observational studies, human subjects issues, special populations and adverse effects. Translational research and potential blocks (from bench to bedside and bedside to community) are also covered. Literature studies of current clinical/translational research are presented by the students. 

Led by Morehouse School of Medicine (MSM) faculty in collaboration with Emory faculty. This course incorporates social science and behavior theory concepts in understanding of health disparities and research in this area; principles and historical roots of effective community engagement and partnership in clinical and translational research; community and academic perspectives in developing and sustaining collaborative, multidisciplinary research; practical issues in conducting community-based participatory research across the continuum of research including planning, implementation, evaluation, dissemination and translation; and ethical issues and current community-based participatory research projects at Emory, MSM, the Atlanta area and rural Georgia. Lectures will be supplemented with case studies and community-based small group activities. The course will be developed and co-directed by Drs. Yancey (MSM) and Kegler (Emory), (Community Engagement and Research Program [CERP] leadership). The candidate textbook will be Community-Based Health Research: Issues and Methods (Springer, New York, 2004), co-edited by the Dr. Blumenthal (MSM and CERP Director) and Dr. Ralph DiClemente (Emory and CERP liaison). 

This course is designed to teach students a wide variety of statistical methods commonly used in the experimental biological sciences. Students successfully completing this course should be able to: understand and implement good experimental design in conducting scientific research, choose and carry out appropriate statistical analyses for a variety of data types, provide sound interpretation of statistical analyses, and critically read and interpret the statistical content of scientific journal articles in the biological and biomedical sciences. 

The focus of this course is drug development, namely the process by which medications are brought from the identification of a condition to be treated to the distribution to patients. The objectives of this course is to be able to describe the necessary steps required to develop a potential medication for treating a particular condition to provide insights to alternative career in science. 

The course is focused on essential information all graduate students should have before beginning animal studies. The course includes discussion of ethics, laws and regulations, environmental variables and quality control, genetical consideration, experimental design and investigative techniques, biological characteristics of laboratory animals, biosafety, and responsible study of animals.