Accra, July 16 GNA – A project that aims to provide decision makers with
independent and objective evidence on the safety and effectiveness of new
anti-malarial drugs is to take off in four African countries including Ghana.
The project, known as the INDEPTH Effectiveness and Safety Studies of
Anti-malarial Drugs (INESS), is to form a basis for malaria treatment policy in
Africa.
The Bill and Melinda Gates Foundation is injecting over 28 million dollars
into the project, which is set to take off in eight demographic surveillance sites
in Ghana, Tanzania, Burkina Faso and Mozambique.
Madam Jessica Milman, an officer with the Global Health Programme run
by the Gates Foundation, said this to a group of journalists from the African
Media and Malaria Research Network in Accra.
Under the four-year INESS project, which is a phase four drug studies, the
current first-line Artemisinin-based Combination Therapy (ACT) malaria drugs
in the four countries would be evaluated to provide information on their safety
and effectiveness.
There is still a lot of unavailable documentation on the ACTs, despite their
large scale utilization.
Drug development consists of four key phases: Phase one, two and three
clinical trials take place under controlled conditions on a few patients.
Such trials for malaria drugs have already been done in Africa and have
established the initial safety and efficacy of newer anti-malarial drugs.
However, large-scale phase four studies - thus far not undertaken in African
settings - are needed to determine the drugs' exact effectiveness and rare side
effects among others.
Madam Milman said the INESS study was a post-licensure study and the
Kintampo and Navrongo Health Research centres were among the eight sites
chosen in Africa to run the phase four trials.
The project would also look at the health systems in the countries in relation
to access and the costs of ACTs, patients' adherence, provider behaviour,
acceptability of the drugs, quality and safety, among others.
Madam Milman said the Gates Foundation had also provided over 17
million dollars to support on-going trials into a malaria vaccine in some
countries in Africa including Ghana.
The vaccine, RTS'S candidate drug, is expected for licensure and use in
Africa by 2014 and it is expected that it would become part of the Expanded
Programme on Immunization to inoculate children against malaria.
Madam Milman said the Gates Foundation was supporting institutions such
as Kintampo and others across Africa with infrastructure and human resource
capacity building and also helping to address various health challenges on the
continent such as tuberculosis, HIV and AIDS, and some neglected tropical
diseases.
She said the Kintampo Health Research centre would begin a phase three
clinical trial into the RTS'S vaccine next month August to test for the efficacy
of the vaccine.
GNA


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