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The Comparative Effectiveness Research Wave: Solving Surfing Techniques
Seminar at the International Society for Pharmacoeconomics and Outcomes
Research (ISPOR)
Annual Meeting
Orlando, FL -- May 18, 2009 |
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Whether we like it or not, the new evidence
‘wave’ includes comparative trials and with it comes the need to
solve new surfing techniques. The future comparative
effectiveness (CE) research agenda inevitably will (and should!)
include comparative real world (aka “pragmatic”) trials.
Traditional research designs are extremely expensive and lengthy
making them not very practical. Further, there tends to be high
uncertainty due to the nature of the messy real world. This
session posed a Bayesian adaptive design approach as a possible
solution to reduce uncertainty of findings, cost, and time, and
featured a series of working papers to address four specific
technical issues (click the title of any presentation for the
PDF version of the presentation given):
Session Chair: Bryan R. Luce, PhD, MBA,
Senior Vice President, United BioSource Corporation
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Introduction of session
by Session Chair
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ROI
elasticity of manufacturers’ sponsoring real world
comparative trials (aka: Just how much does cost, time, risk
need to be decreased for a manufacturer to fund a CE trial
of its product?)
Speaker: Anirban Basu, PhD, Asst. Professor, Hospital
Medicine, Dept of Medicine, University of Chicago
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Building
off the existing evidence (aka: The world may be flat, but
is the prior?)
Speaker: David J. Vanness, PhD, Research Scientist,
United BioSource Corporation
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Getting to
“Yes”. (aka, When do we know (what is the minimal threshold)
when we have “just enough” evidence for a real world (read,
coverage decision maker; clinical guideline committee)
decision?
Speaker: Bryan R. Luce, PhD, MBA, Senior Vice President,
United BioSource Corporation
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The role
of dynamic predictive simulation in guiding the pragmatic,
adaptive trial
Speaker: J. Jaime Caro, MDCM, FRCPC, FACP, Senior Vice
President & Senior Research Scientist, Health Economics,
United BioSource Corporation
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Issues in Comparative Effectiveness Research: Seeking Efficiency
Exploring Bayesian Adaptive Trial Methods
Short Course Offered in Conjunction with
SMDM
Annual
Meeting
Philadelphia, PA -- October 22, 2008 |
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Given the
exploratory issue being addressed and the rapid evolution of
this field, this “short course” was structured more as a
highly interactive issues panel and work in progress workshop
rather than a didactic three hour "this is how you do it". The
short course focused on the opportunity and
methodological/operational challenges to adopting (or
“adapting”) Bayesian adaptive methods for pragmatic clinical
trials (PCTs) in the quest to efficiently develop usable
comparative effectiveness research (CER) evidence.
Objectives:
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Describe
Bayesian adaptive trial methodology
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Provide
examples of previous applications of Bayesian adaptive
trials in pharmaceutical Phase 2 studies
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Present
initial ideas and engage in discussion regarding the
opportunity and methodological/operational challenges to
adopting Bayesian adaptive methods for pragmatic clinical
trials (PCTs)
in the quest to develop usable comparative effectiveness
research (CER) evidence efficiently
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Evaluate
patient-level medical costs
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Evaluate
stochastic uncertainty in cost-effectiveness analysis
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