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December 11, 2012

Comparative Effectiveness Research –
The Role of Evidence Synthesis and Non-randomized Real World Studies

Speakers for this Event:
  • Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI
       Learn More
  • Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America    Learn More
  • The promise of comparative effectiveness research (CER) is the comparison of competing interventions using valid evidence to allow physicians, policy makers, and patients to make informed healthcare decisions.

    The gold standard study design for CER is arguably the pragmatic randomized trial that imposes minimal restrictions on patient entry and clinical decision-making in routine practice. The challenge is that these trials are very costly and may take a long time to complete. Decision-makers therefore need to decide between the value of waiting for evidence from future pragmatic randomized trials or using suboptimal evidence from existing studies, such as randomized controlled trials (RCTs) for registration purposes or non-randomized observational evidence.

    New drugs are often compared with placebo or standard care, but not against each other, in trials aimed at obtaining approval for drug licensing. Even if there was an incentive to incorporate competing interventions in an RCT, the interventions of interest may have changed over time. Hence, for many indications there is no RCT that evaluates all competing interventions of interest. In the absence of head-to-head trials, an indirect comparison can provide useful comparative effectiveness evidence. If the available evidence base consists of a network of RCTs involving treatments compared directly or indirectly or both, it can be synthesized by means of network meta-analysis that can be useful CER.

    Observational studies can help detect important side effects and adverse events that licensing trials with shorter followup would not pick up. Furthermore, observational studies may identify relevant outcomes in populations excluded from registration trials. Methodological developments to minimize bias in observational studies have advanced tremendously over the past few decades allowing for comparative evidence with higher internal validity, despite the lack of randomization.

    Although network meta-analysis of RCTs and observational studies have their limitations, these studies can be useful for the appraisal of competing interventions to inform healthcare decision making.

    In this webinar we will discuss how evidence generated for regulatory purposes can be useful for CER.

    Key Learning Objectives:

    1. How can RCTs designed for drug licensing be combined and indirectly compared with other trials, what are the limitations, and when does it have value
    2. How can data obtained with registries and other observational (late phase) studies be used for CER purposes
    • Senior level executives involved in Marketing and Regulatory Affairs for pharma/biotech companies
    • Health Economics and Outcomes Researchers

    Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy

    • Lead for MAPI Consultancy services in North America, and is globally responsible for comparative- and cost-effectiveness studies. With 10+ years of research and consulting experience he assists clients with developing evidence to support reimbursement and market access of their products.
    • Extensive experience with evidence synthesis (meta-analysis, indirect and mixed treatment comparisons), economic modeling and HTA submissions. He is heavily involved in the development of evidence synthesis methods, is the chair of the AMCP/NPC/ISPOR Indirect Treatment Comparisons Taskforce, and an associate editor for the journal of Research Synthesis Methods.
    • Jeroen is an adjunct faculty at Tufts University School of Medicine in Boston and lectures in Pharmacoeconomics.
    • Education: PhD in Epidemiology from the Erasmus University in Rotterdam.

    Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America

    • 24 years experience in consulting and research in biostatistics, epidemiology and health outcomes
    • Design expertise in retrospective and prospective observational studies, secondary database analyses, PROs and economic studies. Statistical expertise in longitudinal modeling and correlated data methods, model building, propensity score matching
    • Previously head of Epidemiology and Health Outcomes, PPD, Inc. and Pharmacoeconomics and Health Outcomes at Supportive Oncology Services, Inc.
    • Previous academic faculty positions:
      - Associate Professor, Department of Psychiatry, Harvard Medical School
      - Associate Professor, Department of Behavioral Science, UT MD Anderson Cancer Center
    • Education: BS Biology San Diego State University, PhD Biostatistics University of Washington (Completed all coursework for PhD in Epidemiology)

    REGISTRAT-MAPI is the only global CRO dedicated exclusively to Late Phase research. We provide strategic and operational expertise as well as services in the design and conduct of late phase studies globally. We are committed to developing true partnerships with our biopharmaceutical and medical device company clients for ultimate project success.

    MAPI Consultancy sits at the heart of the MAPI Group and is a leading global expert in Health Economics & Outcomes Research and Strategic Market Access. Our purpose is to generate Patient Reported Outcomes (PROs), comparative and cost-effectiveness Evidence for our clients in the (bio)pharmaceutical or medical device industry to inform healthcare and reimbursement decision-making.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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