MERAC - Weill Cornell Medical College in Qatar

Report
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
Member of Middle East Rheumatoid Arthritis Consortium (MERAC)
Wessam G. Elhaq, Mohammed Hammoudeh, Saskia Mandey, Robert M.Plenge, Ziyad Mahfoud , Marjonneke, J Mook-Kanamori ,
Humeira Badsha, Cindy McKeon, Samar Al Emadi, , Layla Kazkaz, Imad Uthman, Hussein Halabi, Basel Masri, Rawan Shayboub,
1
Thurayya Arayssi
Disclaimer
Introduction
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.
The Middle East Rheumatoid Arthritis Consortium
(MERAC)TEAM Members
Introduction
Research Productivity Requirements
Individual, Institutional, and Leadership Characteristics That
Facilitate Research Productivity
Introduction
Research in the Arab Countries
•
Introduction
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
Number of articles published in the Arab world
Introduction
Pub/mill
USA
UK
Canada
France
Lebano
n
Kuwait
Qatar
1129
3347
3759
1805
347
267
226
Example of Research Funding in Arab Countries
Introduction
As shown, the government expenditure on research in Arab region is
10-30% as compared to that spent in developed countries
Our Goal
Introduction
“Create a network of outstanding
collaborators to target the health needs of
patients with inflammatory Rheumatic
Diseases in the Middle East”
Why Rheumatoid Arthritis ?
Introduction
•
Heritability for RA has been estimated to be between 53% and 65%
•
> 50 genetic variants have been identified by means of genomewide(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
The Middle East – RA practice studies
Introduction
Author (yr)
Country
#Patient
%RF+
HLA
%MTX
%
Biol.
Kazkaz (2007)
Syria
156
62.9
+SE
74
Badsha
(2007)
UAE
47
73
-
29
5
Baddoura
(2006)
Leb
298
69.5
-
-
-
Khalil
(2006)
Leb
97
-
-
52
-
Al Saeed (2006)
Kuwait
47
74.4
DRB1*
04
-
-
Al Swailem
(2006)
SA
70
90
DRB1*
04
Facilitating Factors
QNRF vision
Introduction
•
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
SSREP
2006
UREP
Existing program
New program
2010
2007
YSREP
NPRP
SSREP:
UREP:
YSREP:
NPRP:
NPRP-EP:
DFP:
2010
NPRPEP
2011
DFP
Secondary School Research Experience Program
Undergraduate Research Experience Program
Young Scientists Research Experience Program
National Priorities Research Program
NPRP Exceptional Proposals
Distinguished Fellowship Program
Adapted from QNRF presentation, Courtesy of Dr. K. Machaca.
Opportunity: WCMC-Q cores
Introduction
Basic Sciences
Clinical Research

Genomics
• IRB

Microscopy
• Clinical Research Support

Proteomics
• Biostatistics Core

Vivarium
Grant Management
Middle East Rheumatoid Arthritis
Consortium(MERAC)
Introduction
Qatar
UAE
•
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
Jordan
International
Collaborators
WCMCQ
Syria
Lebanon
KSA
First Study : Genetic studies of Rheumatoid Arthritis in
some Arab States (GRAAS)
Introduction
• Goals
•
Methodology( Network establishing)
•
Research plan & study timeline
•
Execution
•
Challenges & Strategies
•
Conclusions
Goals
Introduction
•
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
Methodology
1-Planning :
Introduction
• 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
Introduction
Challenges
Challenges -1. Planning
Introduction
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
Challenges-1.Planning
Introduction
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
Study timeline
MERAC Study Timeline 2011 - 2015
Introduction
2011
Activity
Mar
Planning
Approvals
Infrastructure
Enrolment
Shipment
DNA extration
Data analysis
Publications
Completion
2012
Sep
Mar
2013
Oct
Mar
2014
Oct
Mar
Oct
2015
Mar
Challenges-2.Funding
Introduction
•
Funding resources
•
Awareness of deadlines
•
Be educated about requirements
•
Appropriately detailed budget based on the market prices
Challenges- 3.IRB Approvals
Introduction
•
Ethical awareness of human subject research
•
Be aware of IRB approval processes in the different counties
•
Monitor IRB status & renewals at the multiple centers
Challenges - 4. Selecting team members
Introduction
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
Challenges- 5.Study manual & training material
Introduction
Development of password protected webpage that has study manual, training
material and video
• SOP & forms
• ICF video
Challenges - 6. Patient recruitment
Introduction
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
Challenges- 7. Data collection(clinical data)
Introduction
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
Challenges - 7. Data collection( blood data)
Introduction
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
Challenges - 8. Shipment
•
Introduction
Finding the appropriate courier
•
Securing the availability of dry ice needed for shipment
•
Getting the legalized customs documents in each site
•
Shipment cost
Challenges- 9. Monitoring
Introduction
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 :
1. Standardization
2. Training
3. Assessment
4. Retraining
Achievements
Introduction
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
Future Plans
Introduction
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
The Ten Commandments for Researchers
•
Fully understand the conditions
Introduction
of the country and society.

Commit to involving young
researchers in research projects, and
also to training them
•
Focus on beneficial scientific
research, and do not become
preoccupied with trivial matters.

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.
•
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
Acknowledgements
Introduction
Weill Cornell Medical College-Qatar
Saskia Mandey
Ziyad Mahfoud
Wessam G. Elhaq
Marjonneke Mook-Kanamori
Cindy McKeon
Rawan Shayboub
Thurayya Arayssi
King Faisal Specialist Hospital &
Research center, Jeddah, Kingdom of
Saudi Arabia
Hussein Halabi
Jordan Hospital, Amman, Jordan
Basel Masri
Hamad Medical Corporation, Doha, Qatar Tishreen Hospital, Damascus, Syria
Samar Al Emadi
Layla Kazkaz
Al Biraa Arthritis and Bone Clinic, Dubai,
UAE
Humeirah Badsha
American University of Beirut, Lebanon
Imad Uthman
Broad Institute, Cambridge, MA,
USA
Robert Plenge
Introduction
Thank You

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