CTM-5200 Clinical Trials Research: Practice to Policy
This course provides students with an understanding of clinical research methods as well as current issues concerning drug and device development in the United States. Students will learn how to formulate a scientific literature search to inform their research efforts and will develop the skills that are necessary for critical evaluation of published studies. The design of clinical research will also be discussed in detail so that the student is prepared to recommend what type of study is best suited for answering a particular research question. This will include a discussion about prospective versus retrospective and cross-sectional designs, randomization and blinding methods, and parallel group versus cross-over studies. Next, students will learn about the various approaches for conducting a survey as a part of clinical research, with a discussion about the relative merits of conducting a survey versus using other sources of data. Specific study endpoints will also be discussed in detail, including economic/cost measures, health-related quality of life measures, and work productivity measures. Reliability and validity of study endpoints will be explored so that students are prepared to identify possible sources of error and bias in clinical studies. Finally, students will develop an understanding of current issues related to clinical research, including controversies surrounding the relationship between industry sponsors and researchers as well as the impact of biotechnology and the generics market on product development.