Design, Performance, and Monitoring of Clinical Trials

You will first understand the concept and definition of the clinical trials. Then, the importance and necessity of its implementation will be described. At the next step, this chapter tries to clarify the importance of phases of clinical trials (phases III and IV). In this part, you should pay attention to the type of biomedical studies including pharmaceutical, cell, gene, and tissue investigations which are mentioned. You will learn about fundamentals of clinical trials after their clarification. According to international standards and guidelines, inclusion and exclusion criteria of eligible participants will be demonstrated, and intervention includes concepts like diagnostic intervention. Furthermore, a snapshot of clinical trial monitoring, risk assessment, and its various types will be exhibited with a brief focus on registration and obstacles.