There is agreement on the fact that in the last half century economic globalization has had a strong development. Proponents and proponents underline the benefits in particular of economic growth and well-being, while critics point the finger at the exacerbation of economic disparities and the exploitation of low- and middle-income workers, especially in developing countries. Pharmaceutical companies and medical device manufacturers have seen globalization as a fundamental component of their industrial model.
This has especially happened in the field of clinical trials. On the other hand, this pattern of globalization continues to raise important questions about the economics and ethics of clinical research and how trial results can be used in practice. The global clinical trials market was valued at USD 48.07 billion in 2021 and is projected to reach a value of USD 80.53 billion by 2028, growing by 5.9% over the forecast period (2022 -2028).
ClinicalTrials.gov is a clinical trials registry. It is maintained by the US National Library of Medicine at the National Institutes of Health and currently lists 445,181 studies with sites in all 50 states and 221 countries.
It is known that clinical trials are conducted in four phases and regulatory bodies constantly monitor them throughout the study. Taking into account, according to WHO data published in April 2021, that the burden of chronic diseases is increasing. This should increase interest in clinical trials and stimulate the creation of new medicines. Since the turn of the century, the number of researchers based outside the United States has grown 15% annually suggesting that the same globalization process is underway in clinical research as in other industries. In a first-rate medical center in India, a clinical case costs a few thousand dollars less than one tenth of the cost in a center in the United States. The difference is in the labor costs of physicians, nurses, and study development coordinators. It takes between 10 and 15 years to develop a new drug with a cost of 2.5 billion, but the main cost is in the trials.
The globalization of clinical trials also shortens the time for clinical trials. The largest mean annual growth in clinical trials from 2005 to 2012 occurred in the Asian (30%) and Latin American/Caribbean (12%) regions; other geographic areas had growth rates lower than the world average (8%). That is, it occurred in low-middle income (33%) and low-income (21%) regions. The emerging economies of low- and middle-income countries (Iran, China, Egypt) recorded the greatest country-specific growth, including South Korea, Japan, India, Brazil and Turkey.
The advantages of conducting medical trials in developing countries are clear. Relationships among clinical researchers are growing globally. The safety and efficacy of drugs and devices is of concern to all of us. Nonetheless, the globalization of clinical trials raises ethical and scientific concerns. Local control bodies are structured only for their internal market. Above all, we know little about the conduct and quality of research in these countries that have relatively little clinical research experience. EMA has published a "Reflection Paper" on the ethical and good clinical practice (GCP) aspects of trials of medicines for human use conducted outside the European Union. The guarantees on the conduct and clinical management of the trials are, in the final analysis, in the hands of the contract research organizations.
Antonio Barracca
