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Challenges of setting up a multi-country research consortium across the Middle East The Middle East rheumatoid arthritis consortium (MERAC) Mohammed Hammoudeh , M.D Division of Rheumatology, Department of Medicine, Hamad Medical Corporation, Doha, Qatar

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    1. Challenges of setting up a multi-country research consortium across the Middle EastThe Middle East rheumatoid arthritis consortium(MERAC) Mohammed Hammoudeh, M.D Division of Rheumatology, Department of Medicine, Hamad Medical Corporation, Doha, Qatar Member of Middle East Rheumatoid Arthritis Consortium (MERAC) Wessam G. Elhaq, Mohammed Hammoudeh,SaskiaMandey, Robert M.Plenge, ZiyadMahfoud,Marjonneke, J Mook-Kanamori, HumeiraBadsha, Cindy McKeon,Samar Al Emadi,,LaylaKazkaz, ImadUthman, Hussein Halabi, Basel Masri,RawanShayboub,ThurayyaArayssi

    2. Disclaimer As faculty of Weill Cornell Medical College in Qatar we are committed to providing transparency for any and all external relationships prior to giving an academic presentation. Mohammed Hammoudeh M.D. I DO NOT have a financial interest in commercial products or service.

    3. The Middle East Rheumatoid Arthritis Consortium (MERAC)TEAM Members

    4. Research Productivity Requirements Individual, Institutional, and Leadership Characteristics That Facilitate Research Productivity

    5. Research in the Arab Countries Little is known: There is no pan-national monitor that could prepare quantitative and qualitative research indices for the Arab region and guarantee the credibility of data produced. Funding is low: The amounts spent by Arab countries on research and development is little. Infrastructure is weak :Constraints on scientific research in Arab countries are not limited to the absence or weakness of institutional structures or their lack of staff. They also include the weakness of relevant administrative arrangements and legal frameworks We cannot work together: Joint research projects among Arab scientific research institutions working in similar fields remain extremely rare even within the same country

    6. Number of articles published in the Arab world

    7. Example of Research Funding in Arab Countries As shown, the government expenditure on research in Arab region is 10-30% as compared to that spent in developed countries

    8. Our Goal “Create a network of outstanding collaborators to target the health needs of patients with inflammatory Rheumatic Diseases in the Middle East”

    9. Why Rheumatoid Arthritis ? • Heritability for RA has been estimated to be between 53% and 65% • > 50 genetic variants have been identified by means of genome-wide(GWAS) association studies to be associated with RA in North American and European populations • Little is known about the risk alleles contributing to RA among the patients of Arab ancestry in the Middle East

    10. The Middle East – RA practice studies

    11. SSREP UREP Facilitating FactorsQNRF vision DFP YSREP NPRP NPRP-EP • Established in 2006, QNRF as the sole research funding agency in Qatar seeks to build national human potential by funding research and other activities to accelerate development of opportunities for education and training in basic and applied research related to needs in Qatar. 2010 2006 2010 2007 2010 2011 SSREP: Secondary School Research Experience Program Existing program UREP: Undergraduate Research Experience Program YSREP: Young Scientists Research Experience Program New program NPRP: National Priorities Research Program NPRP-EP: NPRP Exceptional Proposals DFP: Distinguished Fellowship Program Adapted from QNRF presentation, Courtesy of Dr. K. Machaca.

    12. Opportunity: WCMC-Q cores Clinical Research Basic Sciences • IRB • Clinical Research Support • Biostatistics Core • Genomics • Microscopy • Proteomics • Vivarium Grant Management

    13. Middle East Rheumatoid Arthritis Consortium(MERAC) • 6 Clinical and research centers • 8 regional rheumatologists • International collaborators • Develop DNA and clinical databank • Study Rheumatic Diseases (RA) in the Middle East • Submit for funding from regional and international sources

    14. First Study : Genetic studies of Rheumatoid Arthritis in some Arab States(GRAAS) Goals Methodology( Network establishing) Research plan & study timeline Execution Challenges & Strategies Conclusions

    15. Goals Setting up the infrastructure to enroll and collect at least 2000 rheumatoid arthritis patients of Arab ancestry (cases) and 2000 (controls) from 5 Rheumatology centers across 5 Arab Nations Investigate the role of rheumatoid arthritis risk alleles in patients of Arab ancestry Study the demographic and clinical characteristics of these patients Ensure High quality verifiable data

    16. Methodology 1-Planning : Selection of qualified sites & collaborators4 research plan study timeline 2- Funding 3- IRB Approvals 4-Infrastructure Recruiting team members Develop a study manual & training materials Communication 5-Patient Recruitment 6- Data collection Web-based data collection Blood collection & DNA extraction 7-Shipment 8-Data analysis 9- Study monitoring 10- Publication

    17. Challenges

    18. Challenges -1. Planning Selecting qualified sites & collaborators: • Prior research experience • Motivation and commitment • Large patient base • Resources: Freezers, computers…..etc. Developing the research plan: • Creating initial drafts • Reaching consensus for final draft

    19. Challenges-1.Planning Developing a Study Timeline: Be generous when working out time frames Defining the research objectives Define the actual stages of your research Set a realistic timeline Resolving external constraints & meeting deadlines

    20. Study timeline

    21. Challenges-2.Funding • Funding resources • Awareness of deadlines • Be educated about requirements • Appropriately detailed budget based on the market prices

    22. Challenges- 3.IRB Approvals • Ethical awareness of human subject research • Be aware of IRB approval processes in the different counties • Monitor IRB status & renewals at the multiple centers

    23. Challenges - 4. Selecting team members Human Resources: • Finding a previously trained research associate(RA) was difficult • Standardization of staff practice across the different sites • Availability of specialists & making RA attractive to young physicians

    24. Challenges- 5.Study manual & training material Development of password protected webpage that has study manual, training material and video • SOP & forms • ICF video

    25. Challenges - 6. Patient recruitment Total number of patients to be recruited per year with equal number of controls To increase the number of recruited subjects : -Increase the population awareness( brochures & flyers) - Consider a Control Drive: to enroll a greater number of controls totally free from any underlying auto-immune disease & who are not relatives of the cases

    26. Challenges- 7. Data collection(clinical data) Web-based data collection( electronic data entry) • Creation of an electronic survey( questionnaire) to enter the full data of each subject during the enrolment session • Secure internet connection availability in all the collaborating sites • Carry out day-to-day communication with the other sites • Back-up plans in facing web glitches • Collect , monitor, & clean data from all the collaborating centers • Getting on board the expertise in biostatistics, computer programming & data management

    27. Challenges - 7. Data collection( blood data) Blood collection & DNA extraction • Lab space availability • Equipment availability : Freezers, fridges, centrifuge…..etc. • Materials & lab supplies availability : DNA extraction Kits, tubes, pipettes…etc. • Securing of the blood samples

    28. Challenges - 8. Shipment • Finding the appropriate courier • Securing the availability of dry ice needed for shipment • Getting the legalized customs documents in each site • Shipment cost

    29. Challenges- 9. Monitoring Study monitoring: Site visits Audit reports Finance monitoring: Budget monitoring Reimbursement processes Budget re-allocation Data monitoring: Monitoring of the data quality & center performance Ensuring high data quality & inter-site consistency : Standardization Training Assessment Retraining

    30. Achievements 1. A tight, well established multicenter research network with all the constituents to perform ,monitor , publish reliable results & outcomes 2. Productivity after one year One publication One poster presentation Two oral presentations

    31. Future Plans To set up a Scientific advisory Board (SAB) & executive committee for MERAC monitoring the consortium by: • Review of applications for collaboration and requests for sharing material from the investigators outside the consortium • Review of the publications before submission • Advise the consortium in new research area

    32. The Ten Commandments for Researchers • Commit to involving young researchers in research projects, and also to training them • Write highly competitive research proposals, and submit them in requests for support from international institutions. • Publish in respected international journals • Persistently pursue self-education • Believe in and be proud of the scientific research profession. Fully understand the conditions of the country and society. Focus on beneficial scientific research, and do not become preoccupied with trivial matters. Carefully select research projects and methodologies improve communication skills in foreign languages Build local and regional/international networks of cooperation. http://www.mbrfoundation.ae/English/pages/AKR2009.aspx, accessed March 24 2011

    33. Acknowledgements King Faisal Specialist Hospital & Research center, Jeddah, Kingdom of Saudi Arabia Hussein Halabi Jordan Hospital, Amman, Jordan Basel Masri Tishreen Hospital, Damascus, Syria LaylaKazkaz Broad Institute, Cambridge, MA, USA Robert Plenge Weill Cornell Medical College-Qatar Saskia Mandey ZiyadMahfoud Wessam G. Elhaq MarjonnekeMook-Kanamori Cindy McKeon RawanShayboub ThurayyaArayssi Hamad Medical Corporation, Doha, Qatar SamarAl Emadi Al Biraa Arthritis and Bone Clinic, Dubai, UAE HumeirahBadsha American University of Beirut, Lebanon ImadUthman

    34. Thank You