Large Clinical Trials and Registries-Clinical Research Institutes
The growing need for high-quality scientific evidence to inform medical practice and decision-making is placing increasing pressure on the clinical research enterprise. Although new diagnostic and therapeutic technologies offer dramatic opportunities to improve health outcomes, they continue to drive up health-care costs while resources for evaluating such technologies are becoming increasingly constrained. In this environment, researchers and clinicians must have a thorough grasp of the strengths and limitations of various research methods and be able to critically evaluate and apply not only traditional approaches, but also novel techniques now emerging in the era of "big data." In this chapter, we will explore the history, background, and general concepts of clinical research. We will also examine trial design; ethical, legal, and organizational aspects of clinical research; application of statistical methods; and the integration of these concepts into practice. Finally, we will visit current controversies in clinical research and explore future possibilities.
