Thursday, November 10, 2011

USA Africa Dialogue Series - Improving clinical trials and regulatory pathways to fight neglected diseases

Developing countries should take a streamlined, regional approach to regulating clinical trials for drugs against neglected tropical diseases (NTDs), in which a single approval would cover multiple countries. Most NTDs have no effective treatments but, thanks to a large investment in recent years from philanthropic foundations, nearly 240 drug and vaccine candidates are now in development, 90 of which are waiting for late stage clinical trials.

The African Union is also about to receive grants from the Bill and Melinda Gates Foundation via the World Bank and the New Partnership for Africa's Development (NEPAD) to carry out joint assessments of clinical trials. Clinical trials represent as much as 70 per cent of the cost, and most of the time, required to develop a drug or vaccine, says the report. Developing all 90 promising candidates that are ready for phase III trials will cause a funding crunch.

http://www.cgdev.org/files/1425588_file_Bollyky_Clinical_Trials_FINAL.pdf 

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