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Respiratory Effectiveness Group Inaugural Collaborators’ Meeting. Venue: Franklin Hall 3; Marriott Downtown, Philadelphia Date: Sunday 19 May, 2013 Time: 7.30–10.00am Contact: Alison Chisholm, REG Director: alison @ effectivenessevaluation.org.

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respiratory effectiveness group inaugural collaborators meeting

Respiratory Effectiveness Group Inaugural Collaborators’ Meeting

Venue: Franklin Hall 3; Marriott Downtown, Philadelphia

Date: Sunday 19 May, 2013

Time: 7.30–10.00am

Contact: Alison Chisholm, REG Director: alison@effectivenessevaluation.org

part 1 respiratory effectiveness year in review

Part 1Respiratory Effectiveness ½ Year in Review

OPEN SESSION FOR REG COLLABORATORS; CURRENT AND POTENTIAL SPONSORS WELCOMED7.30 am – 8:15 am

meeting objectives
Meeting Objectives
  • Meet each other
  • Review
    • The motivation for the group
    • What’s been achieved so far
    • What REG is funding in its first year
  • Share experience
    • What other real-life work REG collaborators are involve in?
  • Definition and Standards
    • Discuss and agree the framework for a standards document for all types of real-life research
  • Guidelines Group
    • Discuss how REGcan work with guideline groups to see real-life data better integrated within the guidelines
the origins of t he respiratory effectiveness group reg

The Origins of the Respiratory Effectiveness Group (REG)

David Price, University of Aberdeen and REG founder7.30 am – 7:40 am

evolving landscape timeline
Evolving landscape: timeline

2008

2009

  • Brussels Declaration on Asthma: stated a need to include evidence from real world studies in treatment guidelines
  • Michael Rawlins (NICE Chairman): RCTs should be complemented by a diversity of approaches that involve analysing the totality of the evidence base

ATS/ERS

Large, prospective studies in ʻreal-worldʼ settings (e.g., trials designed pragmatically to reflect everyday clinical practice) to ensure they provide content validity as well as reflect clinically meaningful outcomes

2010

ARIA / GA2LEN

Proposed the use of composite measures when evaluating asthma control and called for the measurement properties to be validated in clinical trials

2011

2012

NHLBI expert workshop

Highlighted areas that need strengthening in order to optimize the potential of real-life/comparative effectiveness (CER) research in pulmonary diseases, sleep, and critical care.

REG was founded!

drivers for change eu perspective
Drivers for change: EU perspective
  • Clinical drivers:
    • On-going need to improve patient outcomes
    • Evidence-based decisions require representative data
  • Budget pressures increasing the need to demostrate:
    • Affordability of therapies
    • Value of therapies
  • Pharma
    • Bringing products to market is only the first step
      • Licensing ≠ approved
      • Licensing ≠ reimbursement
      • Licensing ≠ usage
    • Increasing need to invest in demosntrating the value proposition for new and existing products
clinical drivers representative data
Clinical drivers: representative data

Efficacy

x

Population

  • Reversibility
  • Severity
  • Age / sex mix
  • Attitude to disease
  • Smoke exposure
  • Concomitant disease
  • Individual variation in response

“real-life” population of patients

Effectiveness

clinical drivers representative data1
Clinical drivers: representative data

Criteria for selecting asthma patients to a clinical trial:

  • Lung function 50–80% predicted
  • Bronchodilator reversibility
  • No co-morbidities
  • Non smokers or ex-smokers <10 pack years
  • Good treatment compliance
  • Symptomatic and regular relief medication use
  • Good inhaler technique

Travers et al. Thorax 2007

norwegian study of asthma patients to identify who would be eligible for standard clinical trials
Norwegian study of asthma patients to identify who would be eligible for standard clinical trials

1.2%

Patient population

Herland K, et al. Respir Med. 2005;99:11-9

clinical drivers representative data2
Clinical drivers: representative data

Does it matter if we exclude patients with:

  • Lesser reversibility than 20%
  • Active rhinitis
  • Smokers
  • Lower adherence
  • Poor inhaler technique

AND

  • Design the study not like real-life?
  • Study only lasts 3 months?

Yes!

real life research is it new
Real-life research: Is it new?
  • Existing fields and terminology linked to real-life research:
    • Comparative effectiveness research (CER)
    • Epidemiology (pharmacoepidemiology)
    • Health economics (pharmacoeconomics)
    • Health policy (drug policy)
    • Pragmatic randomized controlled trials
    • Personalized medicine
    • Outcomes research (patient-centered outcomes research)
    • Treatment “value proposition”
evidence base hierarchy continuum
Evidence base: hierarchy—continuum

Contemporary View

Traditional View

Evidence continuum – complementary study designs

RCTs Pragmatic Observational trials studies

Experiment, observation, mathematics, individually and collectively, have a crucial role in providing the evidential basis for modern therapeutics. Arguments about the importance of each are an unnecessary distraction. Hierarchies of evidence should be replaced by accepting – indeed embracing – a diversity of approaches.

Sir Michael Rawlins, Head of NICE, Lancet 2008

commercial drivers
Commercial drivers…
  • Testing What We Think We Know. New York Times - August 19, 2012

“The truth is that for a large part of medical practice, we don’t know what works. But we pay for it anyway.”

H. Gilbert Welch, MD,Geisel School of Medicine at Dartmouth

development of guidelines
Development of guidelines

Observational

studies

(pharmaco-

epidemiology):

Safety

Cost-effectiveness

Effectiveness

Interventional

studies

(RCT):

Efficacy

Safety

Effectiveness