Clinical trials ‘essential’ in the fight against malaria
Research Collaborations between European and sub-Saharan African partners are a way of sharing expertise to develop life-saving medicines and vaccines.
The figures are stark, admits Dr Michael Makanga, Executive Director of the European & Developing Countries Clinical Trials Partnership (EDCTP), which funds collaborative research to accelerate the development of new or improved medicines and vaccines to fight poverty-related infectious diseases in sub-Saharan Africa. “Globally, there are 850,000 deaths from malaria every year, with over 90 per cent of these occurring in sub-Saharan Africa,” he says. “And the majority of these are children under five.”
Clearly, what is needed — and urgently — are more antimalarials, vaccines, diagnostics and interventions in vector control (an essential part of malaria prevention). Before these can come to market, however, clinical research and clinical trials are necessary to ensure they are safe and effective for humans under controlled and real life situations.
Prioritising children and pregnant women
Clinical trials highlight where research priorities should be focussed, for example children under five.
Unfortunately, trials are agonisingly slow, taking many years on average, yet their outcomes have eventually yielded successful treatments for, for example, children and have provided more evidence for better clinical management of pregnant women with malaria, and malaria patients who have other infections, such as HIV. Their importance cannot be overstated. The medicines developed and future vaccines as a result of clinical trials save lives.
Currently, about 15 drugs and 18 vaccines are in clinical development, and 28 diagnostics and 12 vector control candidates are in combined early and late development around the world. “Not all will be successful,” cautions Dr Makanga. “But even those which provide negative results can help prevent either further damage, or show other funders not to waste resources in a particular area.”
Trials also highlight where research priorities should be focussed. In the field of diagnostics, for example, this includes infection identification, drug resistance and tracking patients’ progress. “We prioritise research and development on novel drugs and combinations, especially non-artemisinin products and studies in children, pregnant women and drug-drug interactions in malaria patients with co-infections. For prevention we aim to invest in the development of second generation vaccines that target both Plasmodium falciparum and vivax species of malaria.
Malaria research 2003-2016
Research should be of the highest scientific and ethical rigour, irrespective of where it is conducted.
In the fight against malaria, shared expertise is vital, which is why the EDCTP supports clinical research collaborations with European and sub-Saharan African partners. “Malaria is predominantly a sub-Saharan African problem,” says Makanga. “So, in order to address the issue in the most relevant and appropriate way, we have to engage people in the affected countries at all levels, including policymakers. The research has to be driven by local needs and we’re not simply generating scientific data. We are generating knowledge to be translated into policy and practice.
Involving European partners is not only important for their financial and technical resources, the results will be of direct benefit to Europe too, given the global nature of many infectious diseases and, secondly, the global population movements through tourism, trade, employment and migration.
An important research enabling challenge is to ensure strong ethical review and regulatory oversight of clinical research in Africa. “All research should be of the highest scientific and ethical rigour, irrespective of where it is conducted,” says Makanga. “Improved capacity in these areas prevents major bottlenecks in research and development and ultimately speeds up the process of bringing treatment to market.”
The European & Developing Countries Clinical Trials Partnership (EDCTP), which currently has 14 European and 14 African member countries and is supported by the European Union, has been behind numerous research and development success stories in the field of malaria treatment.