Is it unethical to conduct clinical studies in developing countries?
More and more clinical trials are being conducted outside of the United States. And many of those international trials are being organized in developing countries. The New England Journal of Medicine's recent article on the globalization of clinical research says that this trend is fraught with both ethical and medical concerns.
The main reasons for conducting clinical trials in developing countries? Easier patient recruitment and lower costs. Sure, but the main draw is that there are fewer regulations, says U.S. News & World Report.
Aside from the ethical concerns raised in the NEJM article, there are business concerns about off-shoring clinical research. But it's no surprise that the world is shrinking - and clinical research is impacted by this, just like all other parts of the drug development process. What has lagged is our ability to effectively manage the studies that are being conducted around the world.
There are many challenges associated with globalization, centering on logistics, regulation, and communication. Language communication and translations also pose difficulties. For instance, language challenges associated with conversion to electronic data methods involving languages with alphabets other than Latin must also be taken into account. In multinational trials, documentation must be consistently and accurately translated to avoid miscommunications. Informed consent must take language and cultural differences into account. Finally, cultural factors which affect medical attitudes and patient compliance must be well understood.
It's no wonder that there is so much interest in learning how to organize, plan, and execute international clinical trials!
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Categories: clinical research