The City of Hope Clinical Investigation Training Program (CITP) is a yearlong (4 quarter) curriculum designed to present the principles and practices used in the planning and execution of patient-oriented research including principles and methods in biostatistics, clinical epidemiology, clinical trial development, ethics, and good clinical practices of research. Each course can be taken in any order throughout the year. A certificate in Clinical Research is awarded to scholars successfully completing the Program.
Provides an overview of epidemiologic methods and their application to observational studies. Scholars will develop/enhance their ability to evaluate observational studies, including the adequacy of study design and the validity of stated conclusions. Scholars will also acquire the necessary conceptual frameworkto plan an observational study in collaboration with a statistical co-investigator.
Provides anintroduction to the concepts, theory, and application of interventional clinical trials and the statistics commonly used to analyze these studies. This is a Biostatistics/Clinical Investiagation course that builds on basic background of biostatistics, and introductory clinical trials. This course will explore the fundamentals of clinical investigation including: the definition of study goals, application and theory, objectives and outcomes, trial design and outcome monitoring, and result reporting, as well as a brief review of the underlying statistical methods.
Provides a review of the clinical study process as well as continued instruction in trial development. Scholars will experience the "Nuts and Bolts" of a clinical study, from submission, to committee review, activation, and monitoring. Each scholar will actively participate in the submission of a "mock" clinical protocol. The proper design, conduct, and analysis of a clinical study are imperative to the well being of each participant as well as the integrity of the study results. Responsible conduct of research and good clinical practice will be emphasized throughout the course as they are the cornerstones to an effective and efficient clinical study.
This course will alternate yearly, and address topics in protocol writing and development (CI550) and career development awards (CI551). The emphasis of CI550 will be on developing a complete and feasible protocol leading to an efficient, effective clinical study. The classes will combine didactic instruction with small group discussions and "hands on" learning. The emphasis of CI551 will be on early career advancement, competitivegrant writing, and literature evaluation. This course will focus on developing a fundable, career development award suitable for peer review. Evaluations will be through oral presentations and a completed career development application.