Part II: The Global Strategy
2. Control: Overcoming Malaria
4. The Malaria Research Agenda: B. Research to Inform Policy
Research to inform policy defines the type of interventions and programs best suited for the different regional, country and local settings and plays an important role in policy decisions at international and national levels. Of all of the preventive and therapeutic interventions available, only a subset may be appropriate for a particular country or district. What is appropriate can also change as transmission declines and epidemiology changes with improved control measures. Evidence is therefore necessary to guide decisions for Essential Drug Lists, WHO policies, international guidelines (for example the recommendation against artemisinin monotherapies) and country-level policies (e.g. whether LLINs and / or IRS appropriate for the country setting). This research is sponsored by several large international partners, e.g. World Health Organization, Multilateral Initiative on Malaria / Research and Training in Tropical Diseases (MIM / TDR)MIM / TDR is embedded in the UNICEF / UNDP / World Bank / WHO Special Program for Research and Training in Tropical Diseases. MIM
/ TDR evaluates research grant applications from African malaria scientists and awards funds via a competitive peer-review process.
Click for source, the Global Fund, the Bill and Melinda Gates Foundation, and several bilateral organizations.
The challenges facing research to inform policy include insufficient resources, lack of replicable studies, and gaps in the understanding of health systems research.
Insufficient resources. While many recognize the importance of evidence in informing policy decisions, insufficient resources at international and country levels are devoted to research to help guide policy-makers. Policies often need to be specific to be useful. However, policies are sometimes applied more broadly than appropriate to large regions when it may actually only be relevant to a particular setting within the region. Specific issues related to scale-up, control, and elimination are detailed below.
Study replicability. Another overarching issue is the lack of replicability of studies across countries with similar settings. Studies should be designed so that their results can be compared and applied across multiple countries with similar epidemiological and systems settings, informing policy decisions across countries, rather than only those of an individual country. Certainly some studies are context-specific and may only apply to one country; however, opportunities exist to encourage synergies between current research efforts where appropriate. Additionally, ministries of health and malaria control programs need to be engaged on research conducted to enable faster acceptance of results and new drugs once they have been launched.
Health systems research. Another major gap in knowledge is health systems research to inform cross-disease policy issues. Some health systems policies can have significant impacts, positive and negative, on a malaria control program’s effectiveness, and can vary by setting. Research related to costs, clinic user fees, human resources policy, taxes and tariffs on public health interventions, and country health expenditure and how these influence uptake and impact of control efforts will be helpful for policy-makers.
Control stage. There are several research needs which directly relate to the ability to scale-up and control the disease.
Diagnostic research. There is currently disagreement regarding guidelines for diagnosis in children under 5 in high transmission settings. Clinical diagnosis alone has been widely accepted in areas of high transmission and where laboratory access is poor; however some experts feel that this is outdated and that parasitological diagnosis should be encouraged. This change emerges from 1) declining transmission making differential diagnosis more useful, 2) high drug costs and risk of resistance, making presumptive treatment less viable, and 3) improvement of and increased access to diagnostic technology with RDTs. Research to understand the implications of this change in policy should be undertaken, in order to inform local practices.
Vector control. Unclear evidence and recommendations regarding the settings in which IRS and LLINs are most useful are issues. For example, some experts feel IRS is better suited for urban settings where it may be more operationally feasible, while others feel IRS may have more impact in rural settings. Additionally, some believe LLINs can be used more broadly than previously thought. While country circumstances are unique and should inform policy, more research to help guide these decisions is necessary. Additionally, there are questions regarding the impact of combining LLINs and IRS, and the settings in which their combined used could increase effectiveness.
Intermittent preventive treatment (IPT). There is also a gap in knowledge, and hence policy, on intermittent preventive treatment for infants and children, as well as the extent of the appropriateness of IPT for pregnant women in high transmission areas outside of Africa. More research is necessary to create definitive recommendations in this area.
Preventive coverage in sustained control. As countries become successful with control programs and incidence declines, a greater understanding of the required level of preventive coverage to sustain control is needed. Countries in lower transmission settings may be able to relax preventive coverage, but this is hypothetical and unknown. Regarding high transmission settings, it is currently assumed that high levels of coverage must be sustained for long periods of time, but this will vary across settings and levels have not been confirmed by research. If lower coverage levels were sufficient to sustain control, significant costs could be saved.
Resistance monitoring. Ongoing genetic monitoring of resistance rates in mosquito populations is needed to inform policy. Specifically this would include frequent and widespread monitoring of sodium channel mutations (knockdown resistance) in mosquito populations.
Elimination stage. While interest and research on elimination are increasing, elimination still represents a small proportion of total research efforts; some priorities are detailed below.
Elimination readiness research. General indicative recommendations regarding when countries should embark on elimination exists, but further real-world evidence is needed to help diverse countries understand the implications of starting such a program.
Broad-based benefits to elimination. Related to this is the need for a greater understanding of the broad-based benefits of a country or region eliminating malaria. For example, should eliminating malaria in areas historically responsible for resistance be a global priority? More research, and perhaps modeling, should be conducted to understand this impact.
Economic benefits of elimination. There is currently no economic research on the costs and benefits of elimination in different settings. The Malaria Elimination Group is developing a prospectus, to be published in 2009, that will address this issue, but a greater understanding of this area will be helpful in guiding countries in initiating an elimination campaign.
Deployment of policies for new tools and approaches. As R&D results in the development of new and improved tools, there will be a suite of research needed to inform global and country-level policy on their deployment. Related to this are the cost of new interventions and the need for cost effectiveness studies showing where new interventions would be most appropriate. For example, RTS,S is expected to be launched in 2013, and clear policy is needed to determine which locations may be most suitable for this first generation vaccine considering its efficacy levels and cost.
Related to the use of new tools, there are some interventions and approaches which are historically controversial but could benefit elimination campaigns and need more research. Mass drug administration is a controversial approach that may have potential applications in some settings but lacks sufficient evidence for definitive recommendations.
General priorities. Based on the challenges above, the overarching priorities should be:
- Advocacy to increase financial resources devoted to policy-informing research at national and international levels;
- Increasing training opportunities for those involved in research, especially within endemic countries;
- Increasing replicability of research at international levels for multiple settings and regions through greater coordination across stakeholders and engagement of RBM Working Groups and Sub-Regional Networks; and
- Increasing health systems research.
Priorities in the scale-up and sustained control stages. Research to help inform policies relevant to immediate scale-up of interventions are needed for all regions. The key priorities are as follows:
- Research regarding the use of parasitological diagnosis in children under 5 in high transmission settings;
- Greater understanding of settings in which IRS and LLINs may be most effective and appropriate, as well as the impact of combining IRS and LLINs (and where this could be most advantageous);
- More research resulting in clear recommendations for Intermittent Preventive Treatment for infants (IPTi) and children (IPTc) as well as a greater understanding of all the settings in which IPTp is appropriate; and
- Research on minimum required preventive intervention coverage levels to sustain control for low and high transmission settings after achieving certain levels of incidence.
Priorities in the elimination stage.
- Research should be undertaken to define priority areas where elimination would benefit the global community for public-good reasons (e.g. eliminating malaria in areas of Southeast Asia which have been historically the first to encounter emergence of resistance).
- Economic research on the cost and benefits for different settings to pursue and achieve elimination.
- Research to define policy for new tools and approaches (e.g. vaccines, mass drug administration).
Organization Implications: Developing the Agenda for Research to Define Policy
While there have been some collaboration in the past, a group that includes all major stakeholders should be convened regularly to revisit the research agenda in light of increased impact from current control efforts and new strategies. This will include coordinating existing research efforts and planned work, and defining gaps in coverage of specific topics and in the resources to support high-priority projects. An initial focus will be projects needed to accompany scale-up in the 2010 timeframe. The group will also define a sustainable process and a focal body to regularly update the research agenda based on findings and new circumstances and to act as a forum for reviewing and disseminating results.
Additionally, further engagement of RBM Working Groups (WGs) and Sub-Regional Networks (SRNs) in setting the research agenda should be prioritized. They should be involved in the above convening, while researchers should be included in WG and SRN meetings. Creating a focal point within the RBM Secretariat will also help ensure this collaboration occurs.