Outsourcing clinical trials in emerging markets is a rising trend in the pharmaceutical industry. While such study sites offer distinct advantages for infectious diseases and diseases of poverty, gaps in resources must be addressed, particularly training, experience, critical thinking, and professional recognition of clinical trialists, to increase capacity and quality of clinical studies done in Africa and elsewhere.
Also, ICH-GCP 1996 guidelines are subject to sponsor's interpretation, and Western standards on data quality and ethics are not often appropriate for local research sites in the developing world. A pilot collaborative programme at pilot.globalhealthtrials.org has been created to promote country-based trials in developing countries covering a broad range of disease or condition.
doi:10.1371/journal.pntd.0000619
Read full article: Lang, et al. 2010. Clinical research in resource-limited setting
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