REG set up: first steps…

Alison Chisholm7.40 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 RESEARCHCOMMUNICATE,

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 Collaborationso 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 newsletterso 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 organisation2. 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 & sponsors4. Devise and implement an action plan:

o More than a discussion forumo Establish a position of authority:

– Conduct high-quality researcho 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