No matter how compelling, medical research has historically not guaranteed swift regulatory approval, but researchers are finding ways to speed up translation of their conclusions into policy.
In the fight against malaria, it took years of consistent medical results on insecticide-treated bed nets to gain the World Health Organization’s (WHO) recommendation in 2007. Governments will generally not implement an intervention without the WHO stamp of approval.
“After the evidence was collected, it took another decade for effective use of this intervention,” said Fred Binka, dean of the school of public health at the University of Ghana and former board member of WHO’s Roll Back Malaria Initiative.
“The problem was, who was to drive this evidence forward, when was it enough, and how do you move to policy?” Poor communication between researchers could also lead to confusion, difficulty and stalled policy recommendations, Binka noted.
But they are learning how to get approval in less time. After six years of experiments, talks began between WHO and researchers testing seasonal malaria chemoprevention (SMC) in areas of sub-Saharan Africa where the disease is endemic. The WHO recommendation came in March 2012, just one year after the final trial results were published.
About eight out of every 10 healthy children living in endemic areas who are given four doses of anti-malarial drugs during high-transmission periods do not contract malaria. SMC treatment was previously called intermittent preventative treatment against malaria in children.
To speed the approval process, researchers consulted with WHO policy-makers while trials were still in the planning stages, SMC trial coordinator Diadier Diallo told IRIN.
Similarly, scientists working on a malaria vaccine are optimistic that they will receive a WHO recommendation soon after trial results are reported in 2014. The RTS,S vaccine encourages the production of antibodies and T-cells - part of the immune system - which weaken the malaria parasite and reduce its ability to reproduce in the liver.
“All evidence points towards a potential licence for the RTS,S vaccine in 2014 or 2015, with implementation in 2015,” said Brian Greenwood, a professor at the London School of Hygiene & Tropical Medicine (LSHTM) and head of the Malaria Capacity Development Consortium, which is hosted by the university to boost malaria research strength in Africa.
Photo: The Global Fund/John Rae
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When tests are completed, RTS,S will have cost its makers an estimated $220 million since 2007.
Not all methods to control malaria, among other diseases, have taken the “gold standard” approach of scientific trials, said Immo Kleinschmidt, a researcher in the Tropical Epidemiology Group at LSHTM. Rather, common sense and communities have often promoted their use.
“It’s been proposed to adopt a ‘parachute approach’ to evidence-based trials, based on the simple observation that parachutes have never been evaluated through trials yet we don’t doubt their effectiveness,” said Kleinschmidt.
In this approach communities become testing grounds, where - like parachutes - if malaria control methods are properly functioning and effectively used, they will reduce infection and/or the risk of it.
For instance, in 2006 WHO used mostly historical data rather than findings from large trials to promote indoor residual spraying. But such instances are the exception. Community studies alone rarely provide the needed assurance to roll out new malaria interventions, said Kleinschmidt, who agreed that large experiments are always the ideal, but said tests may not work out as planned.
“We should strive to produce evidence of the highest quality, but often we have to resort to designs that don’t necessarily meet the standard, because the real world is inevitably more messy than the ivory tower.”