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This report of the Working Group on Clinical Trials and Regulatory Pathways provides practical policy recommendations to help deliver better, safer, and cheaper medicine and treatment to the 1 billion people suffering from neglected diseases.
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Millions of people die each year from neglected disease for which effective remedies are few and stymied by lack of investment. A surge in funding in the past decade is good news: dozens of candidate drugs and vaccines are now in the pipeline. But before these products can reach the people who need them, they must be tested in risky, expensive, and time-consuming clinical trials with highly vulnerable patients in resource- and infrastructure-poor countries. There is simply not enough funding tosupport the costs and regulatory oversight of such clinical trials.
The Working Group on Clinical Trials and Regulatory Pathways recommends a two-pronged approach to improve the quality and lower the cost of clinical trials in the developing world: (1) establish regional regulatory pathways for the oversight of clinical trials, and (2) build quality and cost-efficiency into trial planning and design. The Working Group provides specific recommendations for each and describes how stakeholders can begin implementing the changes.