Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 87

Who are the main players involved in the conduct of clinical research? To answer this question, let us first look at the reason clinical trials exist.

As we learned from the history of the evolution of clinical trials and drug development, there were incidents where many people were seriously or fatally harmed from using “medicinal” products that were sold on the market. The ensuing public outcry was heard by the government, and legislators created laws that evolved to ultimately require that a medicinal product must be proven to be safe and effective before it can be sold in the market place. (Chapter 1 Good Clinical Practice History)

Until a medicinal product is proven to be safe and effective, the product would be identified as “investigational.” The laws also state that the entity to decide if a product is safe and effective would be a representative of the government and that the method for first proving that a product is safe and effective would be through the conduct of a series of well‐controlled experiments, including trials on human subjects; hence, the requirement for clinical trials. The regulatory authorities established specific rules, regulations, and guidelines regarding clinical research for investigational products. The main players involved in clinical research conduct were identified as the Sponsor, Clinical Investigator, Institutional Review Board (IRB) or Independent Ethics Committee (IEC), the research participant, and the Regulatory Authority. The ICH E6(R2) guidance for Good Clinical Practice provides a unified standard for the generation of such clinical trial data that are intended to be submitted to regulatory authorities (ICH E6(R2) Introduction [1]).

ICH GCP Guidelines define roles and responsibilities for each player involved in the planning, executing, and reporting of a clinical trial: IRB/IEC, investigator, sponsor/CRO, regulatory agency, and research participant. This chapter will define the different types of players and describe their roles and interaction in clinical research. The details of each player's responsibilities are provided in the respective chapters for IRB/IEC (Chapter 8), investigator and sponsor (Chapter 9), the research volunteer (Chapter 10), and the regulatory authority (Chapter 11).