REG set up: first steps…
Alison Chisholm
7.40 am – 7:45 am
Initial wish
“Set up an independent
collaboration platform that will
raise the quality and profile of
real-life (respiratory) research
and achieve better integration
of high-quality real-life data into
clinical practice guidelines for
the benefit of patients and
practitioners”
• Work began in October 2012.o 6-month “set-up phase”o Expect it to run for 4 years
(1 April 2013– 31 April 2017)
• Registered as a not-for-profit social enterprise in early 2013:o Social enterprise: an
organization with a “social mission” that uses its means to achieve its goal rather than to maximize profits.
Set up an independent organization
IDENTIFY RESEARCH NEEDS & CONDUCT
HIGH-QUALITY RESEARCH
COMMUNICATE, DISSEMINATE & EDUCATE:
RAISE AWARENESS, SHARE EXPERTISE
SET, PROMOTE & RAISE STANDARDS
WORK WITH GUIDELINE GROUPS & AUTHORITIES TO BETTER
INTEGRATE REAL-LIFE RESEARCH
Founding Member:David Price
Director:Alison Chisholm
Structure
Multiple sponsors ensure the group’s independence
Internal Research & Implementation
Collaborators
External Collaborators / PartnersSocieties,
guideline bodies, etc
Management Steering Group
REG
Sponsorship: who & what does it mean?• Sponsors OF REG:
o Multiple sponsors – key to demonstrating independenceo Current sponsors have a combination of: unrestricted grants,
reduced-cost data analysis & statistical support and free data access
o Contact Alison for more information about sponsorship.• REG funding:o From pooled sponsor monies, REG will fund activities aligned
with REG’s driving principle, e.g.:– Studies: data procurement, protocol development, ≥1 month of
data analyst & statistical time, abstract development, ≥1 publication
– Publications: coordination, editorial and writing support, submission fees
– Meetings: at key respiratory congresses and events – Lobbying, advocacy: collaborative projects
International network of collaborators
Australia: 2
Canada: 3
China: 2Hong Kong: 1Singapore: 1
Denmark: 1Germany: 3Greece: 1Bulgaria: 1Italy: 2Belgium: 1
France: 2
Netherlands: 6Spain: 4Sweden: 3UK: 19Ireland: 1
USA: 20
South Africa: 1
Brazil: 1
75 independent respiratory experts
united across 20 different countries
Management Committee: sets the strategy and provides rapid decision-making. Members include: a pediatrician, an allergist, a health economist, primary & secondary care representatives, methodologists…
External collaborators: partners• International Primary Care’s Respiratory Group
(IPCRG) UNLOCK Group:o UNLOCK has been working to set minimum
quality standards for observational study datasetso Primary care was the original champion of real-life
researcho Joint ERS session proposal for the 2014 European
Respiratory Society (ERS) Congress
• Applying to set up networks through the:
o ERS Clinical Research Collaborations
o European Medical Authority Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Raise awareness of REG, starting the dialogue...
• Communication platforms developed:o Website:
www.effectivenessevaluation.org
– Central repository for those working in real-life respiratory research
o Twitter, LinkedIn
• Discussions stimulated by:
o Spring newsletters
o Year 1 activity plan, based on:
– Management Steering Committee Meeting discussions (London February 2013)
– REG collaborator suggestions
Sponsorship
• Current sponsors offer a combination of:o Teva & Boehringer Ingelheim: unrestricted grantso Research in Real Life: access to reduced-cost data analysis
& statistical support o Optimum Patient Care: access to the Optimum Patient
Care Research Database (OPCRD) – a UK respiratory database containing EMRs and PROs for ~400,000 respiratory patients
• Grow the pool of sponsors:o Demonstrate independenceo Fund more activities to make the initiative more successful
1. Set the group up as an independent organisation
2. Develop a network of collaborators & devise a structure
3. Open channels of communication:
o Internally: REG collaborators to identify the challenges to be addressed
o Externally: potential partner organisations & sponsors
4. Devise and implement an action plan:o More than a discussion forum
o Establish a position of authority:
– Conduct high-quality research
o Tackle the challenges facing the field:
– Define, promote, communicate standards
– Raise awareness of the field and promote best practice.
– Collaboration with guideline bodies and licensing authorities to better integrate real-life research
Next steps…
Hand over to the REG collaborators to say a few words about some of the
activities REG is sponsoring in year 1
YEAR 1 ACTIVITIES
Research studies