With significant increases in the number of clinical trials abroad; between 1995 and 2005, the number of countries serving as trial sites outside of the United States more than doubled; increasing numbers of clinical investigators, patient visits, study sites outside of US are required. These increases have fuelled the continuing debate surrounding global standards of care and benefit sharing. Concerns have been raised over: cost savings, shift to "disease-burden driven" research, access to large, treatment + naive patient populations = shorter timelines for clinical and naive testing, possibility of in-country drug approval and access to expanding emerging markets and also the increasingly complex and expensive regulatory environment in US.
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Throughout vaccine history there has been numerous attempts to regulate clinical trials and research. International Statements on Research Ethics include:
Â· Nuremburg Code (1947)
Â· Declaration of Helsinki (1964)
Â· Belmont Report (1978)
Â· Council for International Organizations of Medical Sciences (CIOMS) (1982)
Â· International Conference on Harmonization's Good Clinical Practice (ICH GCP) (1996)
Why not download the full presentation and find out all about ethical concerns in the globalization of clinical trials:
Â· What disadvantages to trials conducted outside the developed world – are we depriving patients at home?
Â· The need for greater international cooperation among industry sponsors, CROs and interested governments
Â· Advantages to sourcing a global mechanism to identify ethical and scientific standards for clinical research outside the developed world
Heather Kelly, Associate Director, OneWorld Health