The Globalization of Clinical Trials

Economic globalization has become increasingly prevalent over the past few decades, and the clinical research industry is no exception. Since 2002, the number of active FDA regulated investigators based outside of the US has grown by 15% annually; compare this to the decrease of 5.5% amongst U.S. based investigators. Even though globalization in the clinical trials sector is relatively new, it already has its proponents and critics which leads to the question, who benefits from the globalization of clinical trials?

The number of clinical trials being conducted outside of the United States and Europe has doubled over the past 10 years, leading to a brand-new market of participants and an increase in research in developing countries. One of the benefits of bringing clinical trials oversees is the enormous reduction in cost. Most of this cost difference is due to the lower salaries of physicians, nurses and other staff in the developing countries. The timeline for these oversees clinical trials is also reduced; since there is a larger pool of participants to choose from in developing countries, this can help to accelerate recruitment for these clinical trials. The population size is also attractive to pharmaceutical companies because it can help them overcome regulatory barriers for drug approval. These are some of the important reasons why globalization can impact the clinical trial world. Moving clinical trials to developing countries can help to escape the red tape and expensive regulations in the wealthier countries around the world. Since the cost of conducting clinical trials has become more expensive than the federal funding that they receive, finding a way to make the process more cost effective can have a great impact on research facilities. Globalization can lead to fostering positive relationships amongst the clinical research community and the developing world.

However, there are downsides to this increase in globalization, mainly ethical and scientific concerns. One of the major concerns is ethical oversight; developing countries are comprised of people with lower economic and educational status than those in the developed world. These disparities in the type of participants available to clinical research sites could jeopardize the rights of those patients. This could lead to a lack of understanding about the study taking place or the use of a placebo in clinical trials. In some situations, the financial compensation for research participation could be larger than the patient’s annual wages. The standards of health care in the developing world might give research facilities the ability to conduct ethically concerning trials. Another issue with the globalization of the clinical trial industry is the lack of transparency that can occur. The International Committee of Medical Journal Editors issued guidelines for investigators for participation in study design, access to data and control over result publication. Investigators in these countries might not be as familiar with these guidelines like their counterparts in the U.S. and Europe, leading to less access to trial data or publishing results.

There are obvious benefits and concerns when looking at the globalization of clinical trials. Long-term solutions to this rapid expansion would need to be examined by representatives from both the developed and the developing worlds to include a comprehensive idea of the future of the industry.