Time to analyse tropical disease research
>by Robert Ridley and Hans Remme (Director, TDR; Coordinator, Science Strategy and Knowledge, TDR), May 06
SUMMARY: With so many organizations now at work in global health research, there is a greater need than ever to develop a shared agenda with commonly agreed priorities - so that each group can contribute unique value. An analysis by the Special Programme for Research and Training in Tropical diseases (TDR) should provide insights for a new strategy.
The field of tropical disease research has changed dramatically in the last ten years - and many of these changes are positive. The announcements of large new sums of funding from the Bill & Melinda Gates Foundation, and from developmental agencies and governments, as well as the establishment of many new organizations, notably including several public-private partnerships (PPPs), appear to lead to the conclusion that progress is well underway, and priorities set.
TDR was formally established in 1978 and anticipates its 30th birthday in 2007, it is therefore an appropriate time to consider the global state of tropical disease research - what has been accomplished and what is still needed. Closer to home, it is time to ask: where does TDR play a role? As TDR goes through this process we hope it will also be of value to the wider community.
When the Special Programme for Research and Training in Tropical Diseases (TDR) was established almost thirty years ago as a co-sponsored programme, it was set up specifically because there was so little focus in the area of tropical diseases research - particularly on how to translate research into practical outcomes such as the development of new tools like drugs and vaccines, and their optimal use within a public health context. There was also a need to build research capability in the developing countries, where the diseases were endemic. The need for new approaches was so acute that it required the establishment of an intergovernmental programme – TDR - now sponsored by UNICEF, UNDP, the World Bank and WHO.
Since then there have been some notable advances through partnerships and collaborations. Around half of the new drugs for neglected tropical diseases have been developed through such activities through TDR support and collaboration with pharmaceutical companies; and now there are a multitude of new initiatives and organizations on the verge of developing more new drugs and diagnostics. TDR has also supported research that has led to new delivery mechanisms to get these products to the poorest communities at the periphery of the health care system. For example, it is proud to have been an early supporter of the research that led to ivermectin based onchocerciasis (river blindness) control programmes in Africa. The approach of community directed treatment pioneered in these programmes is now being studied to see if it can be used to manage multiple conditions - and not just river blindness. The interview with Uche Amazigo in this issue [page 6] explains the history and the promise of this approach.
Overall, TDR has supported more than 10 000 projects, trained more than 1 000 developing-country scientists, and contributed to numerous partnerships and collaborative endeavours that have resulted in significant health impact. For example it coordinated multi-centre studies that provided evidence for improved vector control approaches against Chagas' disease. More recently it coordinated with multiple partners the generation of definitive evidence for the policy of introducing artemisinin combination therapy for the treatment of malaria. Further evidence has since been generated within individual countries, especially in Africa, with support from WHO as a whole and notably the African regional office.
TDR has also had an institutional impact in the area of international health research. Working with many partners, it incubated and helped support the establishment of PPPs such as the Medicines for Malaria Venture (MMV) and the Foundation for Innovative New Diagnostics (FIND) - and also supported the development of the Drugs for Neglected Diseases Initiative (DNDi). In addition, it played a critical role in the establishment of organizations such as the Global Forum for Health Research (GFHR) and the Multilateral Initiative for Malaria (MIM).
But where should TDR focus its endeavours for the next ten years, given all these new players and funding? Even with today's expanded funding, there are still limits. And with so many organizations, there is a greater need than ever to develop a shared agenda with commonly agreed priorities - so that each group can be contributing unique value to the health impact that is needed.
Changing global public health environment
Some of the more significant changes in just the past ten years include:
The establishment of the Millennium Development Goals, placing health at the forefront of human development and raising the issues of focused, realizable health targets high on the international agenda. Increasingly, through the reports of the Commission for Africa and others, capacity for research, science and technology have been highlighted as critical elements for improving health and sustaining development.
Increased public awareness and political commitment to global public health issues, and infectious diseases in particular, given that they observe no borders and are recognized as a massive threat to human and national development, economic returns and the redefined domain of human security.
Increases in donor grants for tropical and infectious diseases, especially malaria and TB R&D. There was a 60% compounded average growth rate for malaria R&D funds between 2002 and 2004. Increases in budgets are also expected for organizations focusing on product development through PPPs.
A growing number of players and initiatives. Ninety-two public-private partnerships have been formed to date, with 34 focusing specifically on product development. There is a growing need for analysis to inform donors and stakeholders on issues of prioritization and research needs.
An anticipated rise in activity for the development of pharmaceutical products in several disease areas (e.g. malaria, HIV, TB, visceral leishmaniasis and African trypanosomiasis). Malaria has one of the richest pipelines, with six new product combinations expected in the next five years.
An increasing number of initiatives for controlling and/or eliminating neglected tropical diseases, based on new tools and methodologies developed over the last 30 years, with an increasing emphasis placed on the need for integrated approaches. Four of TDR's target diseases (Chagas, leprosy, lymphatic filariasis and onchocerciasis) are targeted for global elimination, and one, visceral leishmaniasis, is targeted for regional elimination on the Indian sub-continent.
The rise in significance of the disease burden of several classes of infectious disease - such that the overall infectious disease burden is likely to remain very significant for some time to come. This includes HIV/AIDS, with an increase in expected deaths from 50 per 100 000 to 95 per 100 000 by 2030, with consequent impact on other diseases, notably TB. The rise also includes emergent and re-emergent infections, such as Severe Acute Respiratory Syndrome (SARS), Avian influenza and Ebola, and other highly neglected parasitic diseases.
An increasing regional variation in epidemiological and disease patterns, with most of the infectious disease burden focused on Africa and southern Asia.
More research conducted in and by developing country institutions, as seen in a 14% annual increase in the number of tropical diseases publications from disease-endemic country researchers since 2000. There remains, nonetheless, a major gap between the financial and human resources for health research in developed countries compared to developing countries, and also between middle and low-income countries.
Mapping the gaps
To analyse the situation of international health research, it helps to view research as a continuum leading to health impact, as seen in this graphic.
(Source: WHO/TDR, Nature Medicine 2004, 1-4)
The process begins on the left with the phase of exploratory and discovery research, followed by: product development, evaluation and implementation; managing and distributing the knowledge gained; and developing the capacity to conduct and sustain the research within the disease-endemic countries.
However, this process is not always linear, moving from left to right. There are iterative loops feeding back information among the phases in a cyclical manner. Constant throughout all phases is the need to build adequate research capacity in developing countries, so that research gains can be adapted, adopted, owned and sustained by developing country institutions. Effective strategic knowledge management is also needed to ensure the adequate collection, assessment and distribution of the latest evidence, guidelines and research.
In 2006, we see - in the next graphic - the uneven distribution of funding and attention across this spectrum that we believe needs to be addressed. One area increasingly highlighted as needing attention is research into how best to use new tools and implement them within the health system.
(Source: WHO/TDR, Nature Medicine 2004, 10, 1-4)
A continued need for innovation
In product research and development, there is now significant funding, though not necessarily sufficient, for the "big three" -- HIV/AIDS, malaria and TB. But there is very little for the other neglected diseases, and even less for researchers from the disease-endemic countries to participate in this process. We are currently exploring mechanisms that can combine these two goals by bringing developing country scientists together with pharmaceutical companies and universities to investigate promising new leads for drugs and diagnostics.
Implementation research
Many new PPPs have attracted funding to create new drugs, vaccines and diagnostics. These are in the early to middle stages of development. If the PPPs are able to produce what they anticipate, there will be a growing need for field-testing these products in real-life settings. It is one thing to know that a drug works in a laboratory setting and under controlled clinical trials, and quite another to see whether it works and can be administered properly in rural villages with limited access to healthcare systems and workers and a reliance, for example, on community workers. We anticipate a greatly increased need for evaluation and implementation research to identify best practices to support health systems.
Research capability strengthening and utilization
Gains in health research can only be truly sustainable if researchers and research institutions in developing countries are fully integrated into the priority setting of the global research agenda and in implementing it.
Sustaining the effort
Given the many players in the field, many observers cite two additional needs:
Distributing and making information accessible so that everyone has access to the latest research and resources.
Facilitating priority setting - helping to bring the many players together, to work with the governments and funders to develop shared agendas, goals, outcomes and measures of impact.
Measuring R&D needs
What we want to see tomorrow should drive what we do today. There is a continual need to review and analyse what needs to be done, as well as what can be done. In the past, TDR has developed performance indicators to monitor and measure achievements and success. We need to look into the appropriate measures for tomorrow's needs. Measurements like number of scientific articles published and meetings attended are short-term indicators. These will continue to be important, but we are also looking beyond at medium and long-term indicators. For example, which diseases should have which kinds of tools? There will always be limited resources, and a broad, inclusive discussion among governments, policy makers, philanthropic organisations, researchers, and the private sector is needed to have a productive discussion and develop shared goals.
Towards a new vision
This article analyzes some of the gaps that exist in addressing health research and the main focus of many of the new organizations.. An assessment of TDR's mission, mandate and operations will be undertaken soon by TDR's governing bodies. Together with these analyses and discussion an updated vision for the next decade will be developed that can both build on the past but look to the future.
top |