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 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 / Partners Societies, guideline bodies, etc Management Steering Group REG

Sponsorship: who & what does it mean? Sponsors OF REG: o Multiple sponsors – key to demonstrating independence o 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: 2 Hong Kong: 1 Singapore: 1 Denmark: 1 Germany: 3 Greece: 1 Bulgaria: 1 Italy: 2 Belgium: 1 France: 2 Netherlands: 6 Spain: 4 Sweden: 3 UK: 19 Ireland: 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 datasets o Primary care was the original champion of real-life research o 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: –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 grants o 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 independence o 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