Didactic training in clinical investigation is achieved in Northwestern’s established Master of Science in Clinical Investigation (MSCI) program.  This graduate program was established in 1999, supported by an NIH-funded K30 award and additional funds from Northwestern University.  The MSCI program and associated K30 award provide superior training in skills necessary to be a successful clinical investigator. 

Successful completion of the MSCI requires completion of six required courses, three elective courses, and mentored research.  Courses are offered in the evening during all four quarters of the year, including the Summer Quarter.  Trainees will take part in classroom courses during year 1 of the training program, while they are participating in the clinical curriculum during the day. 

Summary of Six Required Courses.

• PUB HLTH 302 Introduction to Biostatistics.
  This course focuses on concepts of descriptive and inferential statistics and the application of statistical methods in medical and health fields. Topics include descriptive statistics, basic probability concepts, probability distributions, estimation, hypothesis testing, correlation, and simple linear regression.
• PUB HLTH 304 Introduction to Epidemiology.
  This course covers measures of disease occurrence, common sources and types of data, major study designs, sources, and methods, as well as problems that occur in epidemiologic studies.
• PUB HLTH 421 Intermediate Biostatistics.
  This course builds on the material learned in introduction to biostatistics. Specifically, the course focuses on multivariate methods of analysis for epidemiologic and clinical studies including correlation, linear regression, logistic regression, Cox proportional hazards regression, and lifetable analysis.
• PUB HLTH 422 Intermediate Epidemiology.
  This course builds on material learned in Introduction to Epidemiology.  This course focuses on multivariate methods of analysis for epidemiologic studies including correlation, linear and logistic regression, Cox proportional hazards regression, and lifetable analyses.  The design, analysis, and interpretation of data from cohort studies as well as case control studies are discussed in depth. 
• PUB HLTH 441 Ethical Issues in Clinical Research.
  Debate and discussion of ethical issues surrounding clinical research studies, including merits of research proposals, both historical and contemporary, from the perspective of an institutional review board charged with the protection of research subjects. Issues include research studies involving prospective cohorts, vulnerable populations, clinical trials, and use of genetic data in epidemiologic research studies.  This course fulfills criteria for instruction in the responsible conduct of research
• PUB HLTH 445 Writing and Peer Reviewing for Publication.
  This is a hands-on advanced course in writing for publication in medical science journals and for grant applications.  This course includes instruction on how to be a successful peer reviewer. The student is expected to prepare an article through 2 peer review cycles to be ready to submit to a journal. 

Summary of Elective Courses Available to Trainees.  Elective courses allow trainees to deepen their exposure to knowledge in a specific research area.  A brief summary of available elective courses follows.

• CLIN SCI 301 Topics in Molecular Medicine.
  Topics covered are related to the molecular pathogenesis, diagnosis, and treatment of disease.
• CLIN SCI 302 Drug Development Process.
  Introduces practical aspects of drug and device development, as well as relevant industry and government policies and regulations.
• PUB HLTH 525 Molecular Epidemiology.
  This course covers both the major theoretical concepts and practical issues associated with conducting research involving molecular biomarkers in human population.
• PUB HLTH 431 Basic Decision Analysis.
  This course covers quantitative techniques intended to inform decision makers at the bedside as well as at the policy-making level. Topics include probabilities, Bayes’ Theorem, sensitivity/specificity of diagnostic tests, decision tree construction and analysis, utility assessment, cost effectiveness analysis, and expert systems.
• PUB HLTH 446 Clinical Trials.
  Fundamentals of clinical trials, including the design, conduct, analysis and interpretation of trial results are covered. Topics include randomization methods, blinding, sample size determination, choice of controls, multi-center issues, data management, interim analysis, and statistical techniques for data analysis.  Recruitment and retention strategies to assure trial validity and success are also covered.
• PUB HLTH 524 Cardiovascular Disease Epidemiology.
  This course covers selected topics in cardiovascular disease with critical analysis of the current epidemiologic literature. Students will have the opportunity to study methodological issues, contemporary findings, and recommendations for future research.
• IGP 494 Colloquium on Integrity in Biomedical Research.
  This course focuses on the integrity of the investigator.  Topics include: falsification of data, conflict of interest, data management, authorship, science and the public, ownership of data, and informed consent. 

Program Flexibility.  Successful completion of the MSCI is one of our program requirements.  However, our program will be flexible, allowing trainees to develop a program that is well-suited to their needs, based on their prior experiences and training.  For example, trainees who have already completed an MPH degree are unlikely to need basic epidemiology and statistics coursework.   Trainees will develop their course schedule with input from their mentors.  All schedules will require final approval by the MAC. 

Courses are offered in the evening during all four quarters of the year, including the Summer Quarter.  Thus, trainees are able to take part in classroom courses during year 1 of the training program while they are participating in the clinical curriculum during the day.  A number of physicians have successfully completed our MSCI program while participating in Northwestern fellowship programs such as cardiology, for example.  Thus, the MSCI coursework is expected to be feasible for vascular medicine trainees.  Trainees will take one classroom course per quarter for credit and are expected to have completed MSCI coursework during the first two years of the training program.  MSCI introductory courses in epidemiology and statistics will precede the 2nd year of the program, when trainees are primarily devoting themselves to their research projects.  Thus the coursework is well timed with trainee investigation.  Each 1.0 unit course consists of approximately 30 classroom hours over a 10-11 week quarter.  Courses that earn 0.5 units meet for 15 hours over the quarter.  Class sizes are between 5 and 40, with the indroductory courses being larger.  A summary of the MSCI program equirements are shown in the table below.

*  Two courses are worth 0.5 units each.  All others are worth 1.0 unit.   ** Will be obtained as part of mentored research performed during years two and three of the vascular medicine training program.