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This brief outlines the recommendations from the report of the Center for Global Development’s Working Group on Clinical Trials and Regulatory Pathways
More than a billion people suffer from neglected diseases, and millions die each year. Effective remedies have been few because of low investment, but with a surge in funding in the past decade, dozens of candidate drugs and vaccines are now in the pipeline. Before these products can reach the people who need them, they must be tested in large-scale clinical trials that are expensive, time-consuming, and risky. These trials must be conducted with highly vulnerable patients in resource- and infrastructure-poor countries where the neglected disease burden exists. There is not enough funding to support the costs and regulatory oversight of these clinical trials. A two-pronged approach to improve the quality and lower the cost of clinical trials in the developing world is needed:
Establish regional regulatory pathways for the oversight of clinical trials.
Build quality and cost-efficiency into trial planning and design.