Rutgers Cancer Institute of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903-2681
This course is designed to outline the concepts of clinical trials and the acquisition of clinically relevant data. It is required of all trainees and taken in the first year of training. The information provided is crucial for the student matriculating in the translational research program, The following topics are discussed: 1. Overview of clinical research process; 2. Study design; 3: Statistical considerations and design of clinical trials; 4: Establishing efficacy and endpoints; 5: Quality of life assessment; and 6: Regulatory considerations in design and implementation of clinical trials.
In order to assure that all trainees have a common basal level of basic science knowledge related to cancer, all trainees participate in a "tutorial" program in basic science fundamentals for cancer research in the fall of their first year in the program. This tutorial consists of nine informal "blackboard" sessions of one to one and a half hours in length, during which program faculty will discuss with the new trainees the basic science principles essential for translational cancer research. This tutorial will include three sessions on the fundamentals of cancer molecular biology, three sessions on fundamental immunology, and three sessions on the fundamentals of pharmacology.
This seminar meets twice monthly and include a short didactic section given by a relevant member of the training faculty followed by discussion of papers and “work in progress” by the trainees. Each trainee and their mentor present an overview and discussion of results once per year. The remaining sessions follow the form of a disease based course focusing on basic, clinical, and translational issues in particular malignancies, providing an overview of disease characteristics. Subjects and papers are chosen to give a comprehensive understanding of the etiology, biology, and therapy of the various malignancies. An additional advantage of this approach is that ongoing research and literature papers are discussed providing examples of studies encompassing both laboratory and clinical aspects of translation. This exposes to “cutting edge” translational approaches to the prevention, diagnosis and treatment of cancer.