Masters of Science in Clinical Research

The Emory Master of Science in Clinical Research (MSCR) degree program is from the Laney Graduate School at Emory University and provides didactic and mentored clinical and translational research training. The degree is designed for participants at Emory University and Georgia Tech who hold a doctorate or equivalent degree (such as physicians and PhD-level scientists) and have demonstrated a commitment to a career in clinical investigation. The purpose of this program is to provide didactic and mentored clinical and translational research training for physicians and other doctoral scientists who need and desire to develop the analytic and other skills necessary for clinical investigation. 

The MSCR requires a minimum of 28 academic credit hours, which include classes, a research thesis, and a written grant proposal. Full time students complete two semesters of class work in the first year. The summer and second year consist of completing required rotations (IRB and Clinical Interaction Network), research project, thesis, and grant. Mentoring is by an established and successful federally-funded clinical investigator.

Admission is rolling and applications are accepted until the class is full. For selected qualified applicants, a limited number of tuition scholarships are available from the Atlanta Clinical & Translational Science Award (CTSA).

Course Descriptions:

Year 1 - FALL:

EPI 761M - Introduction to Clinical and Translational Research Medicine (2 credits):
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.

BIOS 500M - Biostatistics for Clinical and Translational Research (3 credits):
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.

EPI 530M - Analytic Methods for Clinical and Translational Research I (3 credits):
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.

EPI 533M - Data Management for Clinical and Translational Research (2 credits):
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.

EPI 591M - Community Engagement and Health Disparities in Clinical and Translational Research (2 credits):
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).


Year 1 - SPRING:
BIOS 520M - Clinical Trial Design and Analysis (2 credits):
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.

EPI 534M and EPI 534M (Lab) - Analytical Methods for Clinical/Translational Research II (2 credits):
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.

BIOS 509 - Fundamentals of Bioinformatics (2 credits):
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.

EPI 592M - Clinical Research Colloquium (1 credit):
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.

EPI 536M - Analysis of Clinical Research Data (2 credits):
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.

EPI 593M - Ethical, Legal, and Social Issues of Responsible Clinical Research (1 credit):
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 

EPI 594M - Scientific and Grant Writing (2 credits):
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.


Year 1 - SUMMER:
EPI 599R - Investigative Mentored Research Thesis (4 credits):
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.


Year 1 - SUMMER and/or Year 2:
Didactic course work is generally completed in year 1. In year 2, students spend time completing the mentored research thesis, electives as appropriate, grant writing course product, and the CIN and IRB rotations (described below). This allows substantial amount of time to pursue mentored research training or other activities during the second year.

Rotations:

Clinical Interaction Network (CIN) Rotation:
This required rotation is designed to provide exposure to research carried out at a CIN clinical investigation site and resources provided by the CIN. The rotation requires a minimum commitment of 20 hours of effort. MSCR trainees will meet with one of the CIN directors, an ACTSI Research Subject Advocate (to discuss protocols for data safety monitoring plans and other safety issues), a CIN biostatistician, and a program director of other CIN-affiliated programs, based on the trainee's interest and prior background and training. Trainees will also attend CIN Scientific Advisory Committee and CIN Safety Advisory Subcommittee meetings, as well as, CIN sponsored seminars during the month of the rotation, or as scheduled. MSCR trainees will review and critique at least one CIN-based clinical research proposal submitted to the CIN Scientific Advisory Committee meeting they attend. To gain exposure to successful CTR faculty role models, trainees will meet with at least 2 PIs of currently funded and approved projects to discuss their CTR project in depth. To ensure exposure to both hospital and community based research, trainees will spend at least two half-days at each of a tertiary- and a community-based CIN site for this experience The rotation can take place at any of the ACTSI CIN sites.

IRB Rotation:
During the summer semester following the first year or during the fall semester of their second year, MSCR students observe one of the Emory (or MSM) IRB Committees for three meetings. For Emory IRB meetings, check the IRB website for dates of meetings and send your choice of three meetings to Cheryl Sroka by May at the end of your spring semester in the didactic portion of the first year. For MSM meetings contact Yvonne Powers (404-752-1580).

Mentors:

The mentor should indicate an understanding that the mentor's attendance will be required for presentations by the student to the MSCR Executive Committee at the end of the didactic portion of the program and periodically as appropriate until graduation. The mentor's letter should also indicate that he/she will provide feedback regarding development of the trainee's grant application for extramural federal funding.

The mentor should provide a brief outline of the proposed research project in their letter and indicate that he/she has reviewed the applicant's proposed research project summary prior to its submission. As stated in No. 2 above, the research project must be an independent research project feasible to complete in time to collect and analyze data to be used for the MSCR thesis. A presentation or thesis defense will be scheduled in December or January of the second year of the program and the first thesis draft deadline is February 15 of the second year. The final thesis is due in the Graduate School in April of the second year in order to graduate in May of the second year.

It is required that at least one mentor be a senior faculty member and PI of a federally funded (e.g. NIH or CDC) research project, therefore, equipped to mentor the student with writing a NIH grant proposal as required in the grant writing course of the MSCR program (see section entitled "Course Descriptions"). An additional mentor who has expertise in the research area may also be appropriate. Letters will be required from both co-mentors. 

Application:

Applications for the Master of Science in Clinical Research (MSCR) program should be submitted through the Emory University Graduate School; the application is online: www.gs.emory.edu/apply

Contact:
Cheryl Sroka
Project Coordinator
Atlanta Clinical & Translational Science Institute
Research Education, Training, & Career Development
1599 Clifton Road NE
room 1.416
Atlanta, Georgia 30322
404-727-5096
csroka@emory.edu