Starting point. From the beginning of our project we immediately realized the relevance of the multi-level governance in the process of clinical trials. National, and international levels are interconnected and overlapped most of the time, linking different stakeholders in many forms. One of our main goals in this project will be to figure out how stakeholders and actors in the national and international interact, and, particularly, understand how these connections will impact in US clinical trials system.
From National. Clinical Trials are essentially a national process, where each country has built a particular clinical trials system. This is what Arthur Daemmrich called “therapeutic culture” which means that every nation has a very special system with specific characteristics such as stakeholders involved, ways of interactions, and types of internal processes on relating to the production and development of medicines and therapies. In the last decades, increasingly, countries are working in their own Science and Innovation policies in order to improve their international competitiveness and economic growth. For example, most countries are trying to foster and develop a better clinical trials system in order to be competitive in the new Knowledge-based Economy. Other involved stakeholders such as Pharmaceutical and device companies, Advocacy Groups, International Organizations, Investors, Professional Organizations, etc. are similarly connecting at an unprecedented rate, generating many trends on cooperation, partnership, competition and, also conflict at both national and international levels.
To International. Historically, the actors that govern the clinical trials systems were national, but in recent years, pharmaceutical drugs have become implicated at the international level as never before. This has become a worldwide phenomenon, and one of the main topics in the international health, trade, and security agendas. In the last decades, we have witnessed the emergence of a planetary system on clinical trials. As a result many processes are occurring at the same time, nationally and globally, creating new dynamics and feedback among stakeholders:
Globalization: Governments and industry sponsors in wealthy countries are moving trials to developing countries, following the same globalization process as other industries in order to reduce cost in human labor, shorten the timeline for clinical testing, and find new emergent markets.
Harmonization: It is possible to observe the development of a globally harmonized set of rules for drug regulations currently underway with the significant example of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) from 1996, and the Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants, sponsored and organized by World Health Organization (WHO) in 2011.
Regionalization: Finally, emergence of regional processes like the harmonization of rules on clinical trials in the European Union with the New European Law of 2014 raise important questions about national and international dynamics.
Our research project. All these processes, at the national, regional and international level, interconnect and overlap within the clinical trials system. This makes the international comparative study a complex topic with many variables and factors. A systems approach is necessary to study such a phenomena and we hope to be able to make a contribution to this project by outlining some trends, lessons, models, and indices. Only an international and interdisciplinary team can face this complexity. Here is our challenge!
Francisco Del Canto Viterale