Clinical research studies continue to shift south and east.
The advantages of outsourcing to emerging countries are clear: reduced costs, easier patient recruitment, and access to larger numbers of qualified patients in a growing spectrum of diseases.
Even so, sponsors remain challenged to address regulatory differences and overcome linguistic and cultural barriers. Foreign sponsors also have the additional burden of ensuring that international ethical standards are maintained.
The current issue of Applied Clinical Trials has a good article on this topic. Language & Culture in Global Clinical Trials shows that by taking language, culture, and socioeconomic factors into account, sponsors are protecting the public image of clinical research. In addition, the authors recommend that to overcome barriers to global clinical trials, sponsors
must establish a local presence; work with reputable investigators and sites; and partner with language service providers and CROs that have experience in a particular area.The article contains many good references and is available on ACT's web site.
For more on the globalization of clinical research, take a look at the following articles:
- Overseas clinical trials - appalling or good business?
- The challenges of global clinical trials
- Insurance for international clinical trials
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Categories: clinical research