The Harold and Muriel Block Institute for Clinical and Translational Research at Einstein and Montefiore (ICTR) aims to enhance the discipline of clinical and translational research by promoting multidisciplinary collaboration, addressing translational "blocks" in research, providing infrastructure and collaborative support and enhancing training, education and career development. The Belfer Institute has coordinated with the ICTR to identify courses in the methodologies of clinical and translational research that are appropriate for postdoctoral fellows.
Courses in Clinical/Translational Research Open to Postdoctoral Fellows
CLINICAL RESEARCH 101: FUNDAMENTALS OF CLINICAL RESEARCH METHODS: This course is appropriate for those who seek instruction in the basic principles of clinical research methods. Such instruction may be sought to complement a mentored research experience, to help spur interest in and ability to conduct clinical research or to enhance skills in critically reading clinical research literature. Taught in lecture format, the course enhances one's ability to design a feasible clinical research study; to be able to analyze and interpret univariate statistical comparisons; and to distinguish valid from invalid inferences in published clinical research.
Paul R. Marantz, M.D., M.P.H.
CLINICAL RESEARCH 201: EPIDEMIOLOGY AND CLINICAL RESEARCH DESIGN: This seminar course aims to introduce students to clinical research with a focus on epidemiology. The course uses an introductory epidemiology text, along with critical assessment of papers from the scientific (epidemiologic) literature, in order to learn about study designs — both their strengths and weaknesses and how such studies are conducted. Topics covered include basic statistics, cohort studies, case control studies, clinical trials and research ethics.
Paul R. Marantz, M.D., M.P.H.
Ellie Schoenbaum, M.D.
THE DESIGN AND ANALYSIS OF HEALTH OUTCOME/EFFECTIVENESS STUDIES: This course has two objectives: to extend knowledge and understanding of research design options that are alternatives to, or enhance or extend, RCT, cohort, and case-control study designs; and to introduce select statistical techniques that are related to these design alternatives. The course begins with an overview of "effectiveness" research and the concept of risk adjustment. The literature used in this course is multidisciplinary, borrowing from the behavioral sciences as well as the emerging disciplines of prevention science, public health, clinical research, health services research and comparative effectiveness. To better understand the statistical techniques being discussed, scholars will be provided with a data set, or can use their own. Each scholar will be expected to present and write up his or her analysis.
Arthur Blank, Ph.D.
E-mail: email@example.com; Arthur.Blank@einstein.yu.edu
COST-EFFECTIVENESS & DECISION ANALYSIS (Limited to three clinical or postdoctoral fellows per semester): This tutorial in cost-effectiveness and decision analysis provides hands-on experience in designing and implementing a cost-effectiveness study based on an actual project (pending, active or completed) in which the fellow is involved. Through periodic meetings with the instructor, data needs for analysis are identified, sources for obtaining those data from the literature or methods for gathering the data during the project (or both) are explored and an actual or mock analysis is constructed. Techniques taught include structuring and evaluating decision trees, Markov and other state-transition processes, micro-costing, macro-costing, discounting and other adjustments to the value of value streams over time, application and extrapolation of results of clinical and observational studies. At the end of the course, the student will have carried out a cost-effectiveness analysis on his or her own data, or a preliminary cost-effectiveness analysis based on expected data from the project. The results, if based on an actual completed project, should be suitable for publication. If based on expected data, they can serve as preliminary results for including cost-effectiveness analysis in an application for grant funding. Participation in this course is based on permission of the instructor and requires that the individual be actively involved in a real-world investigation to which cost-effectiveness will be applied, or will have completed writing a grant application to which cost-effectiveness will be added as a result of the course. (Dr. Clyde Schechter; dates and times have not yet been determined.)
Clyde Schechter, M.A., M.D.
HUMAN GENETICS: This course covers a broad range of topics in human genetics. It will begin with a discussion of the human genome and the clinical and basic science applications that emerged from the human genome initiative. This is followed by a review of the regulation of gene expression, focusing on basic molecular biology, evolutionary considerations and clinical implications. Then, a series of lectures covers chromosomal disorders, Mendelian disorders, complex traits genetics and the strategies used to identify disease-causing genes, followed by lectures on cancer genetics and epigenetics. Finally, clinical applications of genomic research with respect to pharmacogenomics and personalized medicine are discussed. At some point in the seminar series, clinical research scholars who sign up for the elective will be asked briefly to describe their areas of interest, after which we will discuss how genetic factors might play a role in study design and interpreting data.
Herb Lachman, M.D.