Displaying 1-2 of 2 key documents
Source: Working Group on Clinical Trials and Regulatory Pathways | November 2011
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.
Source: WHO | 2005
This report from the WHO assesses the potential for creating early warning systems for vector-borne disease. It reviews the current state of research for several diseases such as dengue fever, leishmaniasis, malaria and West Nile virus.
The report includes an algorithmic framework for developing early warning systems, outlining data requirements and the different components of the system. It also contains two useful tables: one on the sensitivity of different infectious diseases to climate; and one summarising the existing research, identifying in which region the disease is most common, data availability and proposed actions.
A key problem in developing early warning systems, as highlighted by this report, is that non-climatic risk factors such as population immunity and food security strongly affect the potential for a disease outbreak. Equally challenging is the poor disease surveillance in many developing countries — the authors call on these countries to strengthen these systems, to help in the fight against climate change.
The report concludes that it will be important for researchers not to design these systems in isolation — health policymakers should be included at all stages of the design.