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Safer, Faster, Cheaper Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases

This report provides policy recommendations to help deliver safer and cheaper medical products to people suffering from neglected diseases in developing countries, where they are needed the most.

Although more drugs and vaccines are reaching late-stage clinical development, says the report, they are held back by a lack of funding to support clinical trials, as well as clinical research and regulatory capacity in settings where neglected diseases are endemic. This undermines safety and the validity of clinical data.

The report recommends a two-pronged approach to improving the quality and regulation of clinical trials in the developing world: establishing regional regulatory pathways for the oversight of clinical trials, and building quality and cost-efficiency into trial design and implementation. It also recommends practical steps that can be taken by donors, drug and vaccine developers, and regulatory authorities to begin implementing the changes.

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