Clinical trials law and policy : human subjects protection and global dynamics

This thesis deals with the implications of clinical research specifically, clinical trials in terms of law and policy at the international level. Chapter One presents a comprehensive review of the literature relating to the law and policy of clinical trials, with a specific focus on their international dimension. Chapter Two describes the main rights touched upon by the conduction of and participation in clinical trials. Chapter Three describes the main stakeholders involved in clinical trials (human subjects, sponsors, and investigators) and how their interests align or collide in the face of the need to balance three traditional healthcare competing paradigms: access, cost, and quality. Chapter Four deals with the concerns raised by the globalization of clinical trials, building on one of the most renowned contributions in the field of clinical trials ethics literature. Chapter Five presents a comparative analysis of the European Union and United States clinical trial legal frameworks. Chapter Six focuses on the issue of clinical trials data transparency. The case for registration is taken into consideration because the global dimension of the issue is particularly relevant and the development of an in international set of standards in this context has been successfully achieved thanks to synergy between different stakeholders. Finally, Chapter Seven adopts a more practical approach. It introduces the results of several interviews conducted with clinical trials sponsors, patients and consumer organizations, and investigators and presents the findings of a simple empirical analysis focused on recruitment-dynamics.



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