Curriculum timeline and sample courses
|Identification of mentoring committee, literature review, research hypothesis, resources, such as patient population and/or databases.|
|Methodology and statistical analysis development.|
|January||Completion of proposal; approval by mentoring committee; IRB submission.|
|February-June||Project implementation and data collection.|
Project implementation and data collection/cleaning. Data analysis.
|April-June||Manuscript and grant application.|
The core curriculum (25 credits) teaches the fundamentals of clinical research including biostatistics (introductory), epidemiology (introductory), molecular medicine, and grant writing. Additional core classes designed for this program address health disparities and related issues. This program is offered in partnership with Vanderbilt University Medical Center, which is the site of the Health Behavioral Methods course. All other core courses are given at Meharr
|Core Course Title||Credits|
|Research Project MSCI 722||4|
|Fundamental Principles of Human Research MSCI 723||3|
|Research Ethics MSCI 707||3|
|Epidemiology I MSPH 70001||4|
|Biostatistics I MSCI 702||4|
|Molecular Medicine MSCI 704||3|
|Medical Communications, Grant Preparation and Bridges to Independence MSCI 710||1|
|Health Behavioral Methods MSCI 705||3*|
*Students complete this course at Vanderbilt University.
Adding to the core curriculum is a rich cadre of elective graduate courses taught at both Meharry and Vanderbilt. A minimum of 11 hours of electives is required. The following table shows the courses most frequently utilized, as well as the recommended number of credit hours and location.
|Medical Writing for Clinical Investigators||1|
|Drug and Device Development||3|
|Clinical Economics/Decision Analysis||3|
|Genetic Analysis of Complex Human Traits||2|
|Measuring Pharmacological & Physiological Results||2|
*These courses are offered on the campus of Meharry Medical College. The remainder are completed on the campus of Vanderbilt University.
Research Project Development—M.S.C.I. scholars are required to conduct a mentored clinical research project for Phase I graduation and for consideration for Phase II participation. Mentors are recruited from the faculty of MMC and VU representing a substantial and diverse portfolio of research activities. Program Directors assist the scholar in identifying a mentor after he/she expresses a theme of research interest. A mentoring committee is then developed. The scholar and mentor develop the project hypothesis and thereafter design and implement the research project. Projects can be complementary to but are required to be independent of ongoing work by the mentor. This point is of particular importance because the clinical investigation program demands that each trainee conceptualize, design, conduct and analyze his or her own project. Projects, however, can be derivative of a mentor's work as long as the project meets the previous requirements of "independence." The constitution of each mentoring committee is not formally mandated but must meet requirements of active oversight.
Selected Core Course Details—An understanding of a career in clinical investigation, and of the M.S.C.I. program, can be derived from the description of two core courses, Fundamental Principals of Human Research (Clinical Trials) and Research Ethics.
MSCI 723—Taught at the beginning of the first year, clinical trials is a broad introduction of all of the concepts of the curriculum which serves to display the "breadth" of the curriculum followed, later on in the curriculum, by individual courses that teach the "depth" of each of the topics. Drs. Wolff and Murray teach the course along with the assistance of multiple MMC and VU faculty including former M.S.C.I. graduates. Topics covered in this course now include: (1) Introduction and Historical Perspectives, (2) Choosing Research Question(s) and Objective(s), (3) Design of Patient-Oriented Study Designs, (4) Design of Epidemiological Studies, (5) Hypothesis Testing & Statistical Methods I, (6) Statistical Methods II, (7) Sample Size and Power Determination, (8) Survival Analysis/Cox Proportionate Hazard Models, (9) Interim Analysis and Meta Analysis, (10) Randomization and Blinding Methods, (11) Phase II Studies, (12) Phase III and Multi-Center Trials, (13) Protocol Writing, (14) Phase I and Pharmacologic Studies, (15) Case Report Forms/Budget/Personnel, (16) Questionnaires, (17) Databases for Clinical Trials, (18) Drug and Biologic Development—the FDA Process, (19) Recruitment and Trial Monitoring, (20) Data Safety Monitoring Boards, (21) Evidence-Based Medicine, (22) Quality of Life Issues and Assessment, (23) Economic and Health Outcome Analysis, (24) Research from the Patient's Perspective, (25) Ethical and Legal Principles in Clinical Research, (26) Investigator Responsibilities in Clinical Research, (27) Institution Trial Oversight and the IRB, (28) HIPAA and Data Integrity, (29) Minority and Protected Research Participants, (30) Research in the Community, (31) Writing a Consent Form, (32) Mock IRB, (33) Statistical and Graphic Software, and (34) Writing a Paper Describing Clinical Research.
Research Ethics MSCI 707—The course covers all element of ethics in research and is a major effort to indoctrinate M.S.C.I. scholars in the Responsible Conduct of Research. Elements covered in the course include: (1) Introduction, Organization and Requirements, Pre-Test; (2) Research Ethics: Where Did It Come From, What Does It Mean?; (3) Ethical Theory: Abstraction to Action; (4) "The Codes": Nuremberg, Helsinki, Common Rule, and Others; (5) Would You Become a Research Subject?; (6) Concepts of Race and Ethnicity: Historical and Current; (7) A Historical Perspective: American Eugenics; (8) Consequences: Redress of Disparities in Health and Research; (9) The Social Construction of Race; (10) What Makes Clinical Research Ethical?; (11) "Research" or "Treatment"? The Therapeutic Misconception; (12) Current Controversies: FDA, COI, Evolving Data; (13) IRB Regulations; (14) Ethics in Protocol Design and Issues of Negative Results; (15) "Informed Consent" and Understanding Risks and Benefits; (16) Vulnerable and Special Populations; (17) Recruitment and Retention; (18) Genetics Research and Stored Tissues; (19) Responsible Conduct of Research; and (20) Mock IRB.
These courses are just two examples of the intricacies of clinical investigation—as well as its fascinating possibilities.