Ter illustratie, het NIDIAG project

Transcription

1 Ter illustratie, het NIDIAG project Marleen Boelaert Instituut Tropische Geneeskunde

2 NIDIAG: Syndromic approach to Neglected Infectious Diseases at Primary Care Level

3 Hoe is dit project tot stand gekomen? Waarom heeft dit voorstel het gehaald? Wat zijn de zwakke en sterke punten van consortium opzet? Interacties met scientific officer in Brussel? Waar let ik op nu ik een volgend voorstel ontwikkel voor een HORIZON 2020 oproep?

4 1. Hoe is dit tot stand gekomen? EU 7th Framework Program(FP7) - 6 billion between 2007 to 2013 for health research Call addressed by NIDIAG: THEME HEALTH : Comprehensive control of neglected infectious diseases (NID) On multiplex diagnostic platforms

5 13 partners

6 - July 2009: start proposal development - Nov 2009: project submitted (5.9 Mio ) - March 2010: invitation to negotiate contract - April : revised proposal submitted - Dec : grant agreement signed (5 Mio ) - Start date: 1 nov 2010 for five years - No cost-extension for 6 months (march2016)

7 2. Waarom heeft dit het gehaald? Omdat expert panel unaniem hoge scores gaf op: 1. scientific excellence 2. impact 3. management

8 What is the problem? Most NIDs can be considered severe and treatable Diagnostic issues not well addressed in NID : little evidence, mostly expert opinion, too narrow Single-disease perspective Recent technological advances are untapped potential What do we propose? NIDIAG adopts a radically different strategy: 1. Start from the patient presenting with symptoms 2. Bridge the world of clinicians and test developers 3. Integrated, evidenced-based, syndromic approach

9 3 Clinical syndromes Neurological Syndrome (HAT, neuro-syphilis, CNS TB, cerebral malarial, ) Persistent Fever Syndrome (HAT, VL, enteric fever, malaria, TB, HIV, melioidosis, ) Digestive Syndrome (Schistosomiasis, soil-transmitted helminths ) Most NIDs are captured in the clinical definition of these 3 syndromes Most frequently encountered clinical syndrome at PHC in Disease Endemic Countries

10 NIDIAG s research objectives Objective 1- To develop and validate an integrated syndromic approach based on diagnosis/treatment algorithms for three clinical syndromes that include both neglected and non-neglected diseases frequently encountered in primary care settings. Objective 2- To develop novel diagnostic platforms/assays tailored to specific epidemiological contexts at primary care level in NID-endemic settings. Objective 3- To document the cost-savings and increased efficacy of this integrated syndromic approach for the clinical management of NID, and produce recommendations to policy makers for its broad implementation.

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12 WP2: Clinical epidemiology network (leader F.Chappuis UNIGE) Determine the prevalence of NIDs and other diseases in patients who present to primary health care facilities with three specific clinical syndromes in DEC Identify clinical symptoms and signs that are diagnostic predictors of NIDs and their differential diagnosis Assess the diagnostic performance of readily available diagnostic tools and novel assays in the field in Phase III prospective designs. Incorporate the acquired epidemiological and clinical knowledge and fielddesigned RDTs into diagnosis-treatment algorithms. Evaluate the performance of these algorithms by conducting prospective studies in primary health care settings in several Asian and African countries

13 WP2: clinical epidemiology network Digestive syndrome Persistent ( 2wks) abdominal pain Persistent ( 2wks) diarrhoea Blood in the stools Bloody diarrhoea Persistent fever ( 1wk) Neurological syndrome Seizure Altered consciousness Sensory-motor deficits Cognitive decline Persistent headaches Targeted NID: - Intestinal schistosomiasis - Intestinal helminths - Intestinal protozoa - Intestinal bacteria

14 WP3: Diagnostic development (M.Miles LSHTM) Establish the target profile of Rapid Diagnostic Tests (RDTs) platforms for the three NID-related clinical syndromes, based on the fundamental requirements for use in the PHC setting Screen peer-reviewed literature and industry information and compare adequateness of available RDTs for NIDs Develop for each of the 3 clinical syndromes, several low hanging fruits into testable prototypes and exploit recent technological advances to improve diagnostic platforms for NIDs: 1. For persistent fever syndrome: provide improved serology and antigen detection, with VL as a model system 2. For digestive tract associated NIDs: explore further development of stool antigen detection systems 3. For the neurological syndrome: develop a single-format antibody detection test for HAT and assess the contribution of point-of-care fluorescence microscopy in the field diagnosis of NIDs.

15 WP4: Reference Laboratory (P.Lutumba INRB & J Jacobs IMT) Conduct phase-ii lab evaluations of new diagnostic tools developed both internally (WP3) and externally (external contributors see WP3, task 3.f) Constitute a panel of reference samples for NIDs in cryo-bank to facilitate diagnostic test development Provide the clinical network (WP2) with state-of-the-art laboratory diagnosis tools to achieve exhaustive differential diagnosis for the three clinical syndromes in study regions Strengthen human and institutional capacity for laboratory NID diagnosis in DEC

16 WP5: Economic evaluation Provide economic evidence on optimal diagnostic-treatment strategies at the primary care level in NID-endemic countries. WP6: Quality Assurance System Provide overall scientific and technical oversight for the project. Implement a system of procedures that assures best practice in accordance with ICH/GCP guidelines at all project levels WP7: Dissemination and translation to policy Make the knowledge gained by NIDIAG accessible to the scientific community and a number of distinct target audiences Develop a policy dialogue with DEC health systems allowing for project results to influence clinical management policies IMPACT!!!

17 WP1: Management and coordination of the consortium Define a management framework for the NIDIAG consortium Act as interface between the NIDIAG consortium and the European Commission. Ensure compliance with the rules and regulations established by the European Commission and the consortium agreement Ensure the work and tasks are performed on time, within budget and to the highest quality Inform and update each partner, including the Commission, on the project status, scientific issues, the work planning

18 WP 1: Coordination & Management Task 1.a Contractual, financial and regulatory affairs management Task 1.b Knowledge / information management Task 1.c Work Plan definition Task 1.d Setting up a framework for the NIDIAG periodic reporting Task 1.e Intellectual property management Task 1.f Dissemination and Communication support activities Task 1.g Ethics and gender equity programme Task 1.h Logistic supports for meeting organisation

19 WP1 Deliverables Del N # Deliverables title Expected date 1.1 NIDIAG logo, graphical chart, communication supports (website, extranet, poster, leaflet, newsletter) 1.2 NIDIAG Kick-Off, Consortium and Executive Council Meetings (Month 1, 6, 12, 18, 24, 30, 36, 40, 48) 1.3 Periodic NIDIAG progress and management reports with cost statement sets 1.4 Daily administrative follow-up of the Consortium (finance, amendments, regulatory aspects) 3 DONE Month 18, 36, 54 In progress

20 13 partners

21 NIDIAG coordination: The Governing and decision-making structure The Governing Council Formed by all partners. Decision-making body. 1 vote per Beneficiary. Majority of 2/3 with a The Executive Council Project Management Team (PMT) quorum of 75% of its members. Meets Decision-drafting via annual meetings body. Decide via s Coordinator (M Boelaert, co-leader of WP1, leader of WP5) WP leaders: Jerome (WP1), Francois (WP2), Michael (WP3), Pascal (WP4), Rosanna (WP6), Yodi and Moussa (WP7) European Commission (EC) Coordinator (COO) Governing Council (GovC) Executive Council (ExC) The Coordinator The sole contact point with the EC Marleen Boelaert - ITG Reports to the Commission. Signs all consortium s letters. Receives the Prepayment Independant Advisory Boards (SAB and EAB) WP teams Partners contributing to a WP. WP leader coordinates. Workpackage Teams (WT) Ind. Advisory Boards 5 independent experts. Confidentiality agreements signed Science: Zeno Bisoffi; Steve Reed; Simon Croft ; Momar Ndao Bioethics: Faiza Osman Sudan; Francis Crawley

22 Hoe is dit project tot stand gekomen? Waarom heeft dit voorstel het gehaald? Wat zijn de zwakke en sterke punten van consortium opzet? Interacties met scientific officer in Brussel? Waar let ik op nu ik een volgend voorstel ontwikkel voor een HORIZON 2020 oproep?

23 Alle vragen welkom!