A basic knowledge of various observational and experimental designs will be at the core of the didactic program for all trainees. All students in the Clinical Research Foundation area will be required to participate in select courses. Each of these courses already has been developed and includes enrollees in the Masters Program in Epidemiology or Health Services Research, medical students, and other graduate students.
- Design and Conduct of Clinical and Epidemiological Studies (HRP 225) – This course provides a broad foundation in methods related to clinical and epidemiologic research, including study designs, common study biases, measurement principles, sample size estimation, questionnaire design, development and assessment of diagnostic tests, introduction to multivariate analysis, and interpretation of study results.
- Introduction to Probability and Statistics for Clinical Research (HRP 258)– Fundamentals of probability and statistics for clnical researchers. Equips students with the tools to understand and critically evaluate the medical literature. Topics to include: random variables, expectation, variance, probability distributions, the Central Limit Theorem, sampling theory, hypothesis testing, confidence intervals, correlation, regression, analysis of variance, and survival analysis.
It is noteworthy that much of the material covered in the core courses selected for the students in the Clinical Research Foundation focuses on epidemiologic principles and data analysis. We appreciate that the randomized, controlled, clinical trial is the gold standard of clinical research and, when properly designed and conducted, is viewed as providing the highest standard of rigor for answering cause and effect research questions in clinical medicine. However, it is critically important that students recognize that not all clinical research questions can be addressed using a clinical trial and that not every clinical research scientist will conduct clinical trials. Many investigators will focus their careers on developing new diagnostic or screening tests, conducting prognostic studies to identify factors that affect disease outcome, and developing preventive approaches that will forestall the development of disease. Because clinical research is often observational rather than experimental, the application of strict epidemiological principles is needed to achieve rigor and to avoid or control for the various study biases such as selection bias, measurement error, and confounding that can distort study conclusions.
Additional didactic courses will be recommended on the basis of the research interest and project of each student. These courses include, but are not limited to:
- Advanced clinical and epidemiologic research methods (HRP 226) – The principles of measurement, measures of effect, confounding, effect modification, and strategies for minimizing bias in epidemiologic studies.
- More intensive instruction in Biostatistics (e.g., HRP 261, HRP 262)
- Design and conduct of clinical trials (e.g., HRP 251)
- Observational research (e.g., HRP 224, HRP 226, HRP 228, HRP 250)
- Data analysis (e.g., HRP 206)
- Health services and policy research (e.g., HRP 392, HRP 391, HRP 256, HRP 283)
- In addition, elective courses in very specialized areas such as Molecular Epidemiology (HRP 228), Genetic Epidemiology (GENE 344A), and Topics in Statistical Genetics (GENE 344B) may be pursued.
Non-methods coursework in an area directly related to the proposed research (e.g. to learn about neuro-anatomy for a neurosurgical project) can be eligible for elective credit, but a justification must be provided and permission granted by the Foundation director. Journal clubs and seminars specifically in the domain of research may also be taken, with permission, and with the name and contact information for the seminar coordinator provided. The total number of non-methods courses or seminar/journal clubs cannot exceed a total of 3 credits (I.e. a single 3-credit course or three 1-unit seminars) and documentation of regular (≥ 75%) seminar or journal club attendance must be provided to the SC coordinator. Exceptions can be made for single courses exceeding 3 credits.
Overview of Required Courses
6 units are required with an Application, 12 units are required without an Application
- HRP 225 Design & Conduct of Clinical & Epidemiologic Studies (3 units)
- HRP 258 Introduction to Probability and Statistics for Clinical Research (3 units)