Trial to test anti-malarial drugs takes off

A trial that would provide decision makers across Africa with objective evidence on the safety and effectiveness of new anti-malarial drugs known as artemisinin-based combination therapies (ACTs) has began at the Dodowa Health Research Centre in Ghana.
Other research sites in Kintampo and Navrongo in Ghana together with others in Tanzania, Mozambique and Burkina Faso are to carry out the four-year phase four trials.
A 28-million dollar facility from the Bill and Melinda Gates Foundation is funding the project.
Dr Margaret Gyapong, Director of the Dodowa Health Research Centre, said data on ACTs would be gathered from 52 chemical shops, house holds and health facilities in the Dangwe West district of Ghana, where the Dodowa Research Centre is based.
Speaking to members of the Ghana Chapter of the African Media and Malaria Research Network in Dodowa, she said 376 communities in the district would also be involved in the gathering of information on the safety and efficacy of the anti-malarial drugs. 

Despite their large-scale adoption in the treatment of malaria, ACTs, such as artesunate-amodiaquine, a first line malaria drug in Ghana have not been tested in larger populations.
The trial known as the INDEPTH Effectiveness and Safety Studies of Anti-Malarial Drugs (INESS) is a phase four study and aims at providing evidence on the ACTs to find out if they are efficacious, safe, affordable and accessible among other factors.
ACTs have officially replaced chloroquine in treating malaria across Africa because malaria parasites have become resistant to the old malaria drug.
It is therefore expected that the phase four trial would provide national, regional and international decision-makers and governments across Africa with objective evidence on the real-life safety and effectiveness of ACTs as a basis for malaria treatment policy.
Drug development processes consist of four stages with the phase one, two and three trial being carried out under controlled clinical conditions on few patients to establish the initial safety and efficacy of new products or drugs. The ACTs have undergone the three trial stages in and outside Africa.
The phase four trial or post marketing phase, where the drugs are already in use on the markets, seeks to examine the risks and benefits of the new drug in different and larger segments of the population.
This phase is important because it examines issues such as the longer-term effects of drug exposure on larger populations.
Post marketing surveillance is also important because even the most well designed phase three studies might not uncover every problem that could become apparent once a product is widely used.
Furthermore, the new product might be more widely used by groups that might not have been well studied in the clinical trials and there might be reports of adverse drug reactions once a drug becomes available on the open market.