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Joining forces would save countries money on clinical trials, and speed up drug development for neglected diseases, says a report.
Inadequate regulatory capacity in developing countries means around 90 potentially life-saving drugs, diagnostics and vaccines are lingering in the pipeline, according to a report released yesterday (31 October).
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, says the report by the Center for Global Development (CGD), a think tank based in the United States.
This would speed up drug development, cut costs and save lives, it says.
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 launch of the major new open innovation platform for research on NTDs last week also promises to boost drug development.
But getting treatments to the stage where they can be used involves extensive and expensive clinical trials. Countries often have limited regulatory capacity and unclear approval processes, particularly in Africa, and the need for a single trial to be approved separately in several countries can cause years of delays.
"A single procedure by which multiple countries can work together to approve and oversee clinical trials would allow participating countries to pool scarce regulatory resources, create an efficient platform for capacity building, reduce inconsistencies across national requirements and speed product development and delivery to patients," the report says.
The savings could then be ploughed back into product development, it adds.
Amanda Glassman, CGD’s director for global health policy, said: "There has already been interest from the African Union in putting together something like this using regulatory agencies that already exist in South Africa and Ghana".
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.
And the Central American Commission of Ministries of Health has been working on joint oversight of clinical trials in its region, Glassman added.
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", said Glassman.
But simply increasing funding for phase III trials is not enough, the report says. Reducing the cost of trials, and a more streamlined approach to patient safety in poor settings, are required.
See below for the embedded full report: