As with so many industries in today’s globalized world, clinical research is increasingly electing to outsource its work to other countries, including China, India, Russia, and Brazil. By 2012, it expected that some 65 percent of FDA-regulated clinical trials conducted by major pharmaceutical companies will be outsourced.
What is driving the trend? Advantages include the following:
• Reduced operational costs
• Simplified recruitment
• Better access to large pools of qualified patients
• Positive patient attitudes toward clinical trials
• The growth in the spectrum of diseases in emerging countries that are also present in developed countries
As a result, non-U.S.-originated regulatory submissions account for an ever greater percentage of regulatory submissions. And related agencies are being forced to adapt. The FDA, for example, has set up formal offices in China and India to oversee this developing facet of clinical trial operations.
The challenges in the face of such a significant change in clinical research practice are many and significant. Regulatory differences, for example, remain a major hurdle as does ensuring that international ethical standards are followed.
Language and linguistic demands also figure at or near the top of the list. As with medical translation elsewhere in the industry, language, cultural, and socioeconomic factors must be considered. Insufficient attention to these critical details can severely undermine outsourcing efforts.
For this reason, the authors of a recent paper on the subject entitled “Language and Culture in Global Clinical Trials” recommend that those conducting trials establish a local presence; work with reputable partners; and seek out experienced language service providers.
Till next time,