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Curriculum

Core Curriculum in Clinical Investigation
The core curriculum for clinical investigation is meant to provide didactic instruction in core topics critical to all clinical investigators. All of our trainees, regardless of prior education, will be expected to complete this common core curriculum (or equivalent courses), and will then take additional elective courses depending on their specific research interests. The core courses include clinical research design, biostatistics, epidemiology, legal and ethical aspects of clinical research, and writing grants and scientific publications. Scholars without prior clincal research training are expected to take coursework leading to an MPH or MSCI. Scholars who already possess one of these degrees (MPH or MSCI) will develop a tailored coursework plan that advances their research training.

In addition, trainees are offered elective courses spanning a variety of fields of research and encompassing mechanisms of human disease, the genetics of complex disorders, and therapeutic interventions. A wide array of elective coursework is available at WU and SLU, which will be offered to trainees pursuing the Master of Science in Clinical Investigation (MSCI) at Washington University as well as to students pursuing the Master of Public Health (MPH) at Saint Louis University. Listings of the degree programs and non-degree programs are available.

Core Courses and Activities

PLEASE VISIT http://k30.im.wustl.edu/program/program.html FOR THE MOST UP-TO-DATE INFORMATION REGARDING COURSE OFFERINGS.

The Core Curriculum in Clinical Investigation is a group of several courses that may be taken individually, and when taken as a whole, provides the basic framework of knowledge required for a clinical researcher. Students can register for individual classes by contacting our program coordinator.

1. Scientific Writing and Publishing (2 credits, #529) is offered by Jay Piccirillo, MD, and Karen Dodson, Managing Editor and Director of Academic Publishing Services. Trainees will learn how to conceptualize, write, critique and revise scientific manuscripts for submission. Throughout the semester, they will assume the roles of co-author and co-reviewer. A syllabus is currently being developed.

2. Designing Outcomes and Clinical Research (3 credits, #513) is led by Brian Gage, MD, MSc and includes lectures from faculty of Medicine, Surgery, Otolaryngology and Pediatrics. DOC Research covers how to select a clinical research question, write a research protocol and execute a clinical study. Topics include subject selection, observational and experimental study design, sample size estimation, clinical measurements, questionnaires and data management. The course is designed for clinicians and health care professionals who wish to conduct outcomes and patient-oriented clinical research. Students receive ongoing feedback as they incorporate research design concepts into their own research proposals. At the end of the course, students are required to submit a research protocol or a draft of a manuscript describing their research, and pass the final exam. The course consists of lectures. Each student gives an oral presentation and presents a written paper or grant protocol for discussion and critique by faculty and other students.

3. Introduction to Statistics for the Health Sciences (3 credits, #523) is offered by instructors, Brian Waterman, MPH and Sarah Boslaugh, PhD, MPH. The course is taught in a user-friendly manner with emphasis on use of SPSS, statistical analysis software commonly used in clinical research. The instructors teach basic statistical methods in which clinical researchers should have facility to execute their own analyses. These methods include generation of descriptive statistics, correlations, t-test, chi-square goodness of fit tests, one-way ANOVA and simple regression. The course also introduces additional statistical methods about which clinical researchers should be knowledgeable. These methods, including factorial ANOVA, multiple linear regression, logistic regression and survival analysis, are taught at a level that will allow researchers to conduct basic or preliminary analyses, and will enable researchers to plan broad approaches to analysis of their research. Classes include presentation of statistical concepts underlying specific procedures, and discussion of circumstances under which a procedure is and is not appropriate. Classes also include demonstration of statistical procedures and interpretation of program output. Homework exercises involve executing statistical procedures covered in class with sample data sets.

4. Grantsmanship (2 credits, #528) is offered by Jay Piccirillo, MD, and Karen Dodson, Managing Editor and Director of Academic Publishing Services. Trainees will learn about the three major components of grantsmanship - the fundamentals; how to write a grant and participate in mock study; and how to revise rejected grants for resubmission. A syllabus is currently being developed.

5. Epidemiology for Clinical Research (3 credits, #588) introduces principles of epidemiology as they apply to clinical research. Course-master Mario Schootman, PhD, presents basic tools used in descriptive and analytical epidemiology, which are crucial for making informed decisions in the care of patients. Critical thinking and scientific/analytic competencies are emphasized. The course focuses on common applications of epidemiologic principles and tools in clinical research, in clinical issues and in understanding the medical literature concerning these issues. This is accomplished via different venues that enhance the critical thinking and scientific/analytic competencies for the students who complete the course.

6. Intermediate Statistics for the Health Sciences (3 credits, #524) is offered by course-master, Mario Schootman, PhD and instructors, Brian Waterman, MPH and Sarah Baslaugh, PhD, MPH. Course content builds upon Introduction to Statistics for the Health Sciences and focuses on SPSS, Cox proportional hazards, generalized linear models, multiple linear models, ANOVA, repeated measures, regression, applied modeling, 2X2, ROC curves, checking assumptions and regression diagnostics. Completion of this course enables clinical investigators to work independently with their own data and run their own analyses. Content includes data sets with applied exercises, interpreting output, lab assignments and a midterm and final exam.

7. Ethical and Legal Issues in Clinical Research (2 credits, #510) examines the ethical and public policy questions that arise in research with human subjects. After completing this course, students will be able to: 1) describe the history of human subjects research and the development of its ethical norms, 2) describe an overview of the regulatory framework and the oversight mechanisms which govern human subjects research, 3) identify and promote elements of the research environment that promote research integrity at both the individual and institutional levels, 4) engage in productive and collegial interactions with investigators, research subjects, mentors and trainees, 5) discuss the normative and other philosophical questions arising in human subjects research, and 6) identify distinguishing features of clinical science as a moral enterprise and of investigators as moral agents.

Weekly Seminar Series
There will be a weekly seminar series for all trainees in the CRTC KL2 Career Development Program. An important learning experience in research is the presentation and critical discussion of research ideas and projects at various points in their evolution. Seminars will alternate discussion of work in progress with critical reading of current clinical research in order to practice and enhance analysis and communication skills. Each trainee will formally present his or her own research in progress twice per year for feedback by peers and faculty from multiple disciplines. In addition to presenting their own work in oral and written form for peer and faculty evaluation, trainees will formally review the written proposals of their peers in a way that emulates the duties of a member of an NIH study section. This formal research evaluation exercise has been a highly successful element of other clinical training instruction at Washington University. The Program Director and Co-Directors will lead this weekly seminar, with participation of other core faculty. These weekly, small group, intensive discussions of research issues will be one of the most valuable aspects of the program, allowing trainees to learn in an active and participatory fashion.

Degree Programs

Masters Science Degree in Clinical Investigation (MSCI)
We will offer a MSCI to trainees who successfully complete the requirements of the Training Program. We have explicitly structured the program to allow trainees with diverse interests to complete a Masters Degree. After taking the Core Curriculum, trainees can take further elective course in a variety of fields, including Genetics/Genomics, Bioinformatics, Pharmacogenomics, Genetic Epidemiology, Advanced Biostatistics, Survey research, Health Behaviors, and Health Education. Credit hours will be also awarded for participation in mentored research during the second year of the program. Students may individualize their schedules to take elective courses during the second year instead of the first, or may take additional elective courses in the second year.

Master of Public Health Degree at Saint Louis University
Saint Louis University offers the Master of Public Health in five concentration areas: Behavioral Science and Health Education, Biostatistics, Environmental and Occupational Health, Epidemiology, and Health Policy. Joint concentrations in these areas are also offered. The Professional Option Analytic Track is available to students holding an advanced degree, and is the program most appropriate for most K12 CR Scholars. This track offers a MPH degree with a focus in epidemiology or in behavioral science, and provides for electives to tailor the curriculum to student interests and professional needs.

Non-Degree Programs