Describe the key events in the historical development of the modern pharmaceutical industry.
Outline the key codes of practice and regulatory processes.
Explain how clinical trials fit within the drug development process.
Describe the economic environment within which pharmaceutical companies operate.
The context of the pharmaceutical industry and modern medicine is established. The module's four perspectives on clinical trials are set out.
Factors that gave rise to the modern framework of regulation of clinical trials are traced.
Codes and regulations
The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonisation of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice.
The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed.
Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed.
Multiple-choice mastery assessment.