Methodology in Clinical Investigation
This yearlong course presents principles and practices used in the planning and execution of patient-oriented research, including principles and methods in biostatistics, clinical epidemiology, clinical trial development, and good clinical practices of research.
Provides an introduction to the concepts, theory and application of statistical techniques commonly used in epidemiology and clinical research. The lab may include enrichment topics, related to the lecture topic of the week, and will include descriptions of publicly available databases (SEER, NHANES), other cohort studies (Framingham, A-bomb Survivors), and design of studies (e.g. for grant proposals), etc.
- Explores the concepts, theory, and application of interventional clinical trials, and the statistics commonly used to analyze these studies. This BiostatisticsClinical Investigation course builds on a basic understanding of biostatistics, epidemology, and introductory clinical trials. CI201A is not a pre-requisite for this course, however, CI120B will build on the design and analysis of the observational studies outlined during the first quarter course.
Provides a review of the clinical trial process including more detail in the design of clinical studies. The conduct of such studies is imperative to the well being of each participant as well as the integrity of study results. The history of regulatory oversight will be reviewed as well as each of the steps necessary to develop, initiate and manage a clinical trial according to Good Clinical Practice (GCP). CI201A and B are not pre-requisites for this course - however, CI201C will build on the design and analyses of the studies outlined during those quarters and discuss Good Clinical Practice as it relates to clinical research.
Scientific Writing and Evaluation CI207
Communication and writing are essential skills for individuals interested in a career in clinical investigation. Early career advancement is often dependent on sucessful grant applications and publication of manuscripts. This course will address topices in competitive grant writing and literature evaluation. The emphasis is on developing a fundable, clinical R01 application suitable for peer review. This course is designed to provide an understanding of now to develop a fundable proposal and a feasible protocol for clinical trial, the class will combine didactic instruction with small group discussions and "hands-on" learning. Evaluations will be through oral presentations and a completed R01 grant.