Globalization In Clinical Research
Globalization has become the most significant trend of almost all public activities over the last two decades. Western international corporations re-located the most part of their plants oversees a long time ago. Cars, clothes, food, toys, drugs…almost everything is manufactured today in “so-called emerging regions, especially in … Latin American and Asian countries” (Thiers, F., Sinkskey, A. & Berndt, E., 2008). But as globalization moves forward it discovers new, ‘virgin’ and more cost-effective regions. With no doubt the major and the most promising players here are China and India. And it is true for clinical research trends as well.
What were the main causes of research industry globalization and shift to emerging regions? We can try and list the most common for clinical research industry:
- Expensive labor resources in the developed countries (USA, Western Europe).
- Exhausted potential for growth of market.
- Prolonged time for patients’ recruitment at remarkably higher costs.
- Very strict regulations (though it is also a burden for shift, as “the US Food and Drug Administration does not approve data from trials in which more than 20% of subjects are from developing countries” (Jayaraman, K., 2004))
What are the main opportunities in the emerging regions that make them so attractive for shift? According to Thiers, F., Sinkskey, A. & Berndt, E. (2008), these are mainly the counterparts of the causes for this move from wealthy developed regions:
- opportunity to reach targeted recruitment goal over a short period of time, which allows pursuit of clinical trials at lower costs;
- emerging CROs that cover clinical trials globally;
- market development potential and favorable regulatory and operational environments in emerging regions;
- worldwide harmonization and unification of clinical research regulations.
Unfortunately, apart from opportunities, there are problems and burdens for such shift. The main are:
- ethical concerns (enrollment of patients, conduction of trials procedures) and violation of informed consent procedures.
- often poor quality of data – problems with data integrity, adequacy of medical history description, documentation maintenance, etc.
- confidentiality issues – both in patients and in retrieved trial data.
- “possible inadequacy in regulatory control and overview of clinical research
- chip labor…[compromising] quality data, reliability and confidentiality” (Thiers, F., Sinkskey, A. & Berndt, E., 2008).
- “one of the major issues being faced is appropriately educated and trained personnel” (University of Liverpool/Laureate Online Education, 2009).
Jayaraman, K. (2004) ‘Outsourcing clinical trials to India rash and risky, critics warn’, Nature Medicine 10 (5), pp.440.
Thiers, F., Sinkskey, A. & Berndt, E. (2008) ‘Trends in the globalization of clinical trials’, Nature Reviews Drug Discovery, 7 (1) pp.13−14.
University of Liverpool/Laureate Online Education (2007). Introduction to Clinical Research: WEEK 8 The world, Your world [Online].
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