Drug development process: clinical trials and regulations

This chapter provides a comprehensive overview of the drug development process, focusing on the pivotal roles of clinical trials and regulatory oversight. It delves into the phases of preclinical research, drug discovery, and the transition to clinical trials while outlining the legal frameworks of significant organizations such as the FDA and EMA. The chapter examines the various stages of clinical trials, including postmarketing surveillance, large-scale efficacy research, and early safety testing. It highlights advancements like personalized medicine, adaptive trial designs, and digital health technology while addressing current issues such as high prices, regulatory barriers, and patient recruitment. The chapter also discusses potential future paths, including emerging trends, prospective regulatory changes, and the ongoing need to enhance the drug development process to improve patient care and medical science.