Moving research results into action

TDR news item
8 May 2013

A child dies from malaria every minute¹, with nine out of every 10 malaria deaths worldwide occurring in Africa. Work is underway to eliminate malaria; two projects started at TDR and now being developed in The World Health Organization’s (WHO’s) Global Malaria Programme (GMP) highlight the central role of research in tackling such diseases and show how TDR can work: by initiating the research that provides evidence for both policy and practice.

The first project provides vital information for national disease programmes on the quality of Rapid Diagnostic Tests (RDTs) for malaria, while the second expands community case management of malaria to encompass malaria, pneumonia and diarrhoeal disease – three devastating childhood killers.

“Both of these areas started out as research, and those results are now being used to scale up programmes that will save lives,” says Dr Robert Newman, Director of WHO’s Global Malaria Programme.

Dr John Reeder, Director of TDR, is delighted by the success of the transition of these research projects into action and “looks forward to building the relationship between TDR and the disease control programmes even further, to ensure that research is targeted to make a real impact”.

Malaria diagnostics: helping control programmes select the right diagnostic tests

TDR

Dr Jane Cunningham, a former TDR staff member now working for GMP, has worked with the Foundation for Innovative New Diagnostics (FIND) to secure funding (9.4 million US dollars over 5 years) from UNITAID to develop a sustainable quality control system for malaria RDTs. This includes continued evaluation of RDT quality, pre- and post-purchase, as well as a transition plan to a system that is largely financed by manufacturers and decentralized to national disease control programmes.

Quick and accurate diagnosis of malaria is essential if loss of life is to be reduced and antimalarial drug wastage avoided. WHO currently recommends that everyone suspected of having malaria be tested for the parasite prior to treatment; good quality RDTs can meet this role by detecting parasite proteins in the blood of infected individuals. Their speed, simplicity and accuracy make them ideal for remote, resource constrained settings.

However, procurement officers are overwhelmed with choice. Over 200 tests are available worldwide commercially, showing variable quality under field conditions and differences in ability to detect the various parasite strains (the two most common being Plasmodium falciparum and Plasmodium vivax).

"Before the evaluation programme, only a small percentage of RDTs were meeting the WHO procurement criteria, but 2011 data suggest 83% of tests now do so."

2011 FIND survey

Dr Cunningham was a key player in coordinating the first four rounds of RDT evaluations carried out since 2008 under a WHO-FIND Malaria Evaluation Programme. This partnership of TDR, WHO, FIND, the US Centers for Disease Control and Prevention (CDC) and others has led to 168 products being evaluated (Rounds 1-4), encompassing 128 unique products and 29 product resubmissions.

The results of the RDT evaluations have been used by GMP to develop RDT procurement recommendations, with the latest guidelines setting a new RDT quality threshold: RDTs must detect 75% of samples at low parasite concentration with a low number of false positives and invalid results. FIND has incorporated evaluation results into a web-based interactive guide further aiding countries in their procurement decisions. Not only is the programme of work providing data on test performance but it is also appears to be having a positive impact on test performance and shifting markets towards better quality tests. The latter was illustrated in a 2011 FIND survey of 17 major RDT manufacturers which revealed that before the evaluation programme, only a small percentage of RDTs were meeting the WHO procurement criteria while 2011 data suggest 83% of tests did so.

Dr Cunningham now carries out the work she began at TDR in GMP. Round 5 of product testing is now underway and plans for transitioning to a long term sustainable model are underway. As she highlights, there are great benefits of now working under the GMP umbrella: “My work is immediately relevant to all who are working in GMP, underpinning both surveillance, control and case management efforts”.

Making the project sustainable involves moving from the current use of clinical samples that must be collected in the field and are costly to characterize, store and ship, to using recombinant antigens which can be manufactured. FIND is leading the selection, development and evaluation of recombinant antigen panels that can be used to evaluate RDTs and test lots of RDTs before they are deployed to the field or in the field, if test quality is suspect.

Overall, the RDT evaluation programme that has been developed for malaria RDTs could serve as a model to assess other types of RDT for other diseases, meaning TDR’s initial investment may have an even broader value.

Malaria treatment: scaling up integrated community case management to tackle other childhood killers

TDR

Another former TDR member now working in GMP, Dr Franco Pagnoni, has helped secure a five year, 74.5 million Canadian dollar grant from the Canadian International Development Agency to support integrated community case management (iCCM) in five African countries: the Democratic Republic of the Congo, Malawi, Mozambique, the Niger and Nigeria. Community case management of malaria has gradually evolved from a successful strategy for home management of malaria to this far broader strategy that addresses three major childhood killers in low-income countries: malaria, pneumonia and diarrhoea.

Dr Pagnoni played a key role in the initial malaria-focused studies at TDR. It was those research results, in part, that led to the development of this new proposal to develop the Rapid Access Expansion (RAcE) implementation programme. Community health workers will be supplied with diagnostic tests and drugs by various non-governmental organizations (NGOs) and be trained to diagnose, treat or refer cases of malaria, pneumonia and diarrhoea.

"Successful implementation of the programme could save tens of thousands of lives of children aged between two and 59 months in the five countries alone, and would mean it could go on to save lives elsewhere in Africa as well as countries in other continents."

Dr Robert Newman, Director of WHO’s Global Malaria Programme

The initial RAcE programme will be overseen by WHO staff posted at headquarters in Geneva as well in the regional and country offices of Africa, representing a collaboration between staff working on malaria and maternal and child health at the three levels of WHO. Dr Pagnoni emphasizes the importance of WHO’s involvement: “The fact that, by definition, WHO is a partner with ministries of health means that the latter’s involvement with the programme is much stronger” – a detail that will ensure the programme meets real needs in countries and that will favour sustainability of the programme after handover to the ministries of health”.

Proposals were selected from among a number of large NGOs, and Dr Pagnoni is now leading the team coordinating the work of consortia led by Save the Children in Malawi and Mozambique, the International Rescue Committee in the Democratic Republic of the Congo and World Vision in the Niger. Successful implementation of the programme could save ten of thousands of lives of children aged between two and 59 months in the five countries alone, and would mean it could go on to save lives elsewhere in Africa as well as countries in other continents.