Ethics of clinical trials outsourcing and conduct in LMICs, with a focus on India.Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage. Over the last few years, there has been continuing outrage on the issue of rising outsourcing of clinical trials to India, with concerns about little benefit or relevance to the public health needs of the country. While this dust has not even settled, allegations of unethical conduct in clinical trials have again brought a focus on the need for regulatory reform and stringent ethical safeguards. India, as an emerging economy needs to continue to promote a strong culture of research and development, including in the health sector. However, attention needs to be paid to ensuring that stringent quality checks are built in, and that investigators conduct research in an impeccable manner. Failure to do so will dent the credibility of the research enterprise, affecting not just investigators or institutions conducting research, but also those planning to do so.
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Bookmarked by Anant Bhan on 10 May 2012
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Today we have launched the pilot for the Global Health Clinical Trials website. We aim for this to be a ...
Thiscourse covers the essentials of study design and protocol development, bioethics,good clinical practice (GCP), data management, regulatory affairs, safety monitoring,and practical management skills.
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Secondary analysis of clinical trial data reveals dengue burden
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