In the developed world, companies drive the diagnostics research agenda so that once a prototype is developed; the products will be driven through the various phases of evaluation, introduction and adoption. The lack of a profitable market has resulted in apathy on the part of the diagnostics industry to develop diagnostics appropriate for the developing world. Public sector efforts at funding diagnostic development have increased in recent years but have been uncoordinated and fragmented.
This BL will build on the foundation established as described and pull together public and private sector players in the existing fragmented landscape to ensure that patients in resource poor settings have access to new and appropriate diagnostic tools.
DR will facilitate the work of major public sector test developers such as the Foundation for Innovative New Diagnostics (FIND) and the Program for Appropriate Technology in Health (PATH) by providing well-characterized specimens and strains from its network of biobanks. TDR provides seed funding through its Bright Ideas Programmers for innovations which can be transitioned into FIND and PATH for larger investments into a diagnostic product. For test evaluation:
TDR is a unique position to provide independent or bias-free evaluation data to member states so that they can select the most appropriate test for their control programmers. Private companies and public sector test developers such as FIND and PATH are perceived to have an inherent conflict of interest in conducting evaluations of the tests on which they have made large investments. TDR collaborates with over 30 public health and research institutions on field trials and demonstration projects on the utility and cost-effectiveness of new tests to provide UN member states with evidence for policy. These include the US Centers for Disease Control and Prevention, Institute for Tropical Medicine, Antwerp, Belgium, London School of Hygiene and Tropical Medicine, International Consortium on Diagnostics in Canada, Infectious Diseases Research Institute in Seattle, USA, National Institute for Medical Research in Tanzania, Kenyan Medical Research Institute, Fundacao Alfredo da Matta in Brazil, Instituto de Medicina Tropical “Pedro Kouri” in Cuba and the National Center for STIs in China.
For test introduction and sustainable adoption: TDR works with WHO partners, including the STOP TB Partnership, the Global Malaria Programmed, WHO’s Neglected Tropical Diseases, WHO’s Reproductive Health Research Programmed, country disease control programmers, research institutions, NGOs such as Médecins Sans Frontiers to conduct test introduction and implementation research to increase access to diagnostics and to ensure that diagnostic tools are used appropriately.
ACTIVITIES AND END PRODUCTS
4.1 KEY ACTIVITIES Objective
To define needs and set standards for diagnostic quality by:
a) Synthesizing existing knowledge by conducting systematic reviews to identify gaps in knowledge and define needs
b) Modeling the test performance needed to maximize impact and cost effectiveness
c) Convening meetings to define diagnostic needs, product specifications and contexts for use, with special considerations for diagnostics that will enhance access for the poor and address issue of gender inequity
d) Developing and promoting standards for diagnostic research by convening consultations to develop guidelines for the design and conduct of diagnostic evaluations
e) Advocating for more stringent regulatory control of diagnostics in the developing world
a) Providing information on needs and product specifications to promote, facilitate public and private sector developer engagement
b) providing a diagnostics target prioritization forum for accelerating the discovery or novel diagnostic targets (in collaboration with Business Line 3) c) funding “bright ideas” projects for novel or improved test formats d) establishing a network of biobanks to provide well-characterized reagents and strains and specimens to facilitate test development and evaluation
Objective 3.
To assess and assuring diagnostic performance and quality by: a) assessing and strengthening diagnostics trial sites, including the provision of training and accreditation for Good Clinical Practice and Good Clinical Laboratory Practice (GCLP) b) establishing international standards for the design and conduct of diagnostic evaluations c) funding assessments of diagnostic test performance and operational characteristics to determine whether they are appropriate for settings intended use d) improving quality of diagnosis by assisting countries with the establishment of quality assurance and proficiency networks e) developing a prequalification scheme to ensure UN member states have access to quality assured diagnostics
Objective 4.
To increase access to diagnostics in the developing world by:
a) Inclusion of diagnostics of acceptable performance and operational characteristics into the WHO Bulk Procurement at negotiated pricing
b) Developing a policy platform for accelerating the translation of research evidence on the utility of diagnostics into control policy
c) developing a road map and framework for the introduction and sustainable adoption of appropriate diagnostics in the developing world, including the development of a advocacy package that details estimation of disease burden, attributable benefit of accessible and/or improved diagnostics in alleviating disease burden, results of systematic reviews on the effectiveness of current tools and mathematical model outputs on estimated impact and cost-effectiveness
d) convening consultations to develop user guides and manuals e) conducting studies to validate model outputs to provide evidence for policy development f) conducting operations research to demonstrate feasibility and effectiveness of new tools, and socioeconomic and gender-based research to ensure equitable access.
4.2 END PRODUCTS
The end products associated with these activities are in 2 broad categories:
Disease-related products including:
diagnostic needs and product specifications defined for each priority disease
novel diagnostic targets for priority diseases
data on the performance and operational characteristics of commercially available tests for priority diseases
inclusion of at least 2 diagnostics in the WHO Bulk Procurement Scheme for each priority disease
Products that is cross-cutting for all diseases including:
Diagnostics pre-qualification schemes established for all priority diseases
Quality assurance schemes for diagnostics with accepted performance
International standards for the design and conduct of diagnostic evaluations published for each disease
A framework and policy platform for accelerating the translation of diagnostic research evidence into policy
A validated framework and roadmap for the introduction and sustainable adoption of promising diagnostics into the developing world
Specifically, the end products by objective are as follows:
To define diagnostic needs and set standards for diagnostic quality:
Diagnostics needs and product specifications defined for each priority disease (2010)
Publication and dissemination of systematic reviews (2010)
Published guidelines for design and conduct of diagnostic evaluations (2009)
Network of diagnostic trial sites that are GCP and GCLP compliant (2012)
Improved regulatory control of diagnostics in countries (2009-2013)
Mathematic models available for countries to adapt for estimating impact and cost effectiveness of improved diagnostics (2011)
To facilitate test development
TDR biobanks as source of reference materials for test developers (2009)
Enlarged spectrum of stakeholders engaged in diagnostic test development (2011)
Annual funding of Bright Ideas Projects (ongoing)
Launch of a forum for accelerating diagnostic target prioritization with engagement of developing country scientists (2008) 3. To assess and assure diagnostic performance and quality
Network of diagnostic trial sites established with the capacity to conduct their own diagnostics research (2011)
Diagnostics clinical trial site directory available online (2008)
Publication of the results of at least ten evaluations of diagnostics appropriate for primary health care settings in developing countries (2012)
Establishment of a diagnostics pre-qualification scheme for priority diseases (2012)
National quality assurance programmed established in countries planning to adopt new diagnostics (2012) 4. To increasing access to diagnostics in the developing world:
Preferential pricing and bulk procurement of new diagnostics available (2013)
Countries adopting new diagnostics based on assessment of evidence (2013)
Framework and policy platform developed for accelerating the translation of research evidence into policy for countries considering adoption of new diagnostics (2011)
Validated roadmap for the adoption, introduction and sustainable implementation of new diagnostics (2011)
User guides developed by countries for the use of diagnostics for each priority disease (2012)
Dynamic models for estimating the impact and cost-effectiveness available to countries for different strategies for introduction and implementation of new diagnostics (2013)
Systems for monitoring continued effectiveness of diagnostics in countries (2013)
Increased access to diagnostics for women and poor or marginalized populations (2013)
4.3 INTERIM IMPLEMENTATION MILESTONES
As the diagnostic business plan involves a matrix of activities under 4 objectives for 7 diseases along a path leading from test development through test evaluation to their eventual introduction and adoption, the description of the implementation plan can be somewhat complex. The focus of diagnostic activities for each of TDR’s priority diseases depend on the current needs for that disease in terms of test development, test evaluation or test introduction and sustainable adoption. For example, Human African Trypanosomiasis (HAT), visceral leishmaniasis (VL) and tuberculosis (TB) require intensive investment in the area of test development as existing diagnostics are neither sensitive nor accessible. For schistosomiasis and dengue, a number of diagnostics are currently being evaluated. For sexually transmitted infections and malaria, commercially available tests have been evaluated in laboratory and field trials and some have acceptable performance. Thus TDR’s current efforts are focused on assisting countries with developing training materials, user guides and quality assurance programmers and formulating policy for introduction and sustainable adoption.
Disease-related products including:
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