TAG publishes 2nd edition of
Tuberculosis Research & Development: A Critical Assessment


Tuberculosis Research & Development:
A Critical Analysis
second edition
by Cindra Feuer
edited by Javid Syed and Mark Harrington
with Bob Huff
October 2006

Table of Contents:

    Foreword
    Executive Summary & Recommendations
  1. Introduction
    1.1 The Importance of TB R&D
    1.2 Limitations of Current TB Tools
    1.2 Objectives
    1.2 Methodology
    1.2 Limitations of the Data
  2. Results
    2.1 Donor Categories
    2.2 Research Investment Categories
    2.3 TB R&D: Ten Major Funders
    2.4 Other TB R&D Funders
    2.5 Challenges Estimating Industry R&D Investment
    2.6 Funding Recipients: PDPs and Research Consortia
  3. Tuberculosis R&D: A Close-up
    3.1 Basic Science
    3.2 TB Diagnostics
    3.3 TB Drugs
    3.4 TB Vaccines
    3.5 Operational Research
  4. Funding for TB R&D in Context
    4.1 TB R&D Relative to TB Control
    4.2 TB R&D Funding Relative to Other Diseases
  5. Recommendations
  6. Conclusions
  7. Appendix A: Top 40 TB R&D Funders in 2005
  8. Appendix B: Actual or Potential TB R&D Funders Not Reported On
  9. References

Tuberculosis Research & Development: A Critical Assessment

Recommendations

    Research Agenda
  1. A comprehensive, global TB R&D agenda is urgently needed. A TB R&D agenda needs to incorporate the entire spectrum of research that is needed to achieve the goals set forth in The Global Plan to Stop TB. This comprehensive research agenda should also address the need for major expansion of the basic and operational research foundation that would support new tool development. In addition, each of the Plan's New Tool Working Group used different (and in some cases incompletely documented) methods of calculating their ten year research needs. In particular the New Diagnostics Working Group estimate seems to be woefully short of the great need for investment in a breakthrough there, while the New Vaccines Working Group evidently lacks a detailed public workplan.
    2. Research Coordination
  2. TB R&D need to be better coordinated globally and nationally. TAG's analytic review demonstrates not only that TB R&D is severely underfunded, but that funders do not adequately coordinate their efforts globally, by research area, or in high burden countries. While philanthropic and public agencies were forthcoming with estimates for TB research, internal tracking systems were inconsistent and incomplete. Some funders did not code grants by specific disease, let alone research area or phase. TAG recommends the standardization of internal tracking systems according to disease (including the separation and coding of diseases that are studied in combination such as TB and HIV), research category, and research phase to enable more comprehensive annual tracking of R&D investments in all diseases of global health importance, including TB.
    3. Research Funding Transparency
  3. Pharmaceutical and biotechnology companies need to be transparent and open about their investments in TB R&D. The lack of transparency by some major players in the commercial sector prevents us from obtaining a clear understanding of the extent of private investment in TB R&D. Six of eighteen companies contacted provided detailed investment data for 2005 (two anonymously); four declined to provide any data; three did not respond; and five stated that they did not fund TB R&D. TAG recommends the private sector present its investments in TB R&D publicly. This will help inform efforts by policymakers, research funders, and TB control programmers worldwide to coordinate their investments in TB research.
    4. Reporting Consistency
  4. Recording and reporting for TB R&D funding needs to be consistent and comprehensive. TAG recommends that agencies responsible for tracking global R&D investments in TB create uniform and consistent criteria for tracking programs and for reporting on them annually. This work could be carried out by the Stop TB Partnership, if it were fully funded and staffed at an adequate and sustained level, with new expert staff dedicated to this work. It would be important for this research tracking effort to be seen as independent and unbiased. For this reason TAG suggests that the research tracking effort be carried out independent of the current New Tools Working Groups whose work will also be tracked. This will facilitate developing an accurate picture of R&D investments and needs forecasting specifically designed to measure progress toward achieving The Global Plan funding targets. In addition, R&D tracking needs to specify whether research is pre-clinical, clinical, or operational, to ensure that all phases of R&D and new tool development are adequately funded. For example, this report demonstrates that new drug development receives relatively greater investment than do other new tool areas, yet support for clinical trials for TB drug development remains anemic.
    5. Recommendations to Donors, Researchers, Policymakers, and High Burden Countries
  5. TB R&D investment must increase fivefold, from approximately $400 million per year to $2 billion per year for basic science, applied, and operational research in order to meet the ambitious R&D targets specified in The Global Plan.
  6. Donors and developing-country policymakers must commit to global and national plans for health-related research.
  7. Donors must support policies that strengthen healthcare systems in resource-constrained countries and high-burden countries.
  8. Donors must recognize and support public-private product development partnerships (PDPs) for their work in catalyzing basic, translational and clinical research, particularly on new tools.
  9. Donors must explore and support incentive mechanisms such as advanced market commitments to attract private industry to TB research.
  10. Donors and research agencies must incorporate activists in the TB community into research program planning and execution.11
  11. Donors, research agencies, and high-burden countries must support community advocacy efforts to elevate TB's political profile and mobilize community to demand care, prevention, treatment, and research.
  12. Donors, research agencies, and high-burden countries must demonstrate transparency and provide funding to allow for an ongoing and sustained effort to comprehensively map and annually update investments in TB R&D.
  13. Donors, research agencies, and planners must support scientists from outside fields, such as HIV/AIDS, to integrate expertise from different disciplines. Researchers must recruit new scientists to the field and promote innovative approaches to TB research.
  14. Regulatory agencies like the U.S. FDA, the EMEA, the South African Medicines Control Council (MCC), and others must commit to support guidelines to accelerate the study and licensure of new TB diagnostics, drugs, and vaccines.
  15. Policymakers must ensure that new tools recommended for use by the national or regional regulatory authorities will be fully incorporated into TB programs.
    16. Towards a Global TB Research Movement: Recommendations to Advocates
  16. TB research advocates should articulate the need for high-level commitment to support TB research, using evidence of this and future tracking reports to expose failures of commitment.
  17. TB research advocates should use economic and epidemiological data to engage ministries in donor countries and HBCs to allocate funding for TB research.
  18. TB research advocates should demand support for affected communities to create TB visibility and awareness, and to elevate TB's profile among policymakers and other political leadership.
  19. TB research advocates should build stronger linkages with the HIV community and other advocates, such as labor unions and poverty-reduction organizations working in at-risk or high-burden communities.
  20. TB research advocates should continually assess accomplishments of current and planned TB-research project funding to determine whether the allocated funds are well placed and sufficient.

Tuberculosis Research & Development: A Critical Assessment

TB/HIV Project Index TAG index

Treatment Action Group