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Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix F: Discussion Paper: Transforming the Economics of Clinical Trials
Pages 183-192

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From page 183...
... 2 Participants in the activities of the IOM Forum on Drug Discovery, Development, and Translation. This discussion paper was presented in draft form at the Forum's November 2011 workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, and finalized by the authors following the workshop.
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From page 184...
... Understanding this process is critical to our understanding of ways in which we can address the underlying cost issues in clinical research. In his classic book The Innovator's Dilemma, Clay Christensen describes how new technology is brought to market by new companies through new business models, leading to cost and quality improvements over time (Christensen, 1997)
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From page 185...
... There are two components of this model -- the core technology for clinical research and the core business model for clinical research. A decade ago, clinical research relied largely on paper-based technology, in which site investigators would record their data on special, multipart case report forms (CRFs)
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From page 186...
... . As we consider approaches to enable business transformation that will keep pace with new technology and the escalating need for informa tion about the practice of medicine, it would be wise to first articulate a common goal for the clinical research enterprise: to facilitate the efficient conduct of high-quality clinical trials to address pressing medical ques tions and evaluate therapeutic interventions.
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From page 187...
... . As technology evolves and industry sponsors, academicians, or the regulators themselves identify practices and guidelines based on outmoded business processes, collaborative initiatives such as the Sensible Guidelines group (Yusuf et al., 2008)
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From page 188...
... It would be worthwhile also to consider the local cultural and financial incentives of academic and government institutions that engage in clinical research and clinical care. If clinical research is the collection of information about the practice of medicine, new technology and business models that promote efficiency should enable many more clinical ques tions to be addressed and enable more potential savings by identifying expensive but ineffective interventions.
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From page 189...
... Incum bent business models inherently fight business-process transformation when given the opportunity, either consciously or unconsciously. Experi ence is used to argue for the current business model with regulators, and, in the absence of organizations representing business transformation, this acts as a potent force.
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From page 190...
... CONCLUSION The economic crisis in clinical research is driven by the inability to transform the business model for research as the core informatics technology evolves. A concerted, multi-stakeholder effort to address adoption of new business models for clinical research is a critical step in unlocking the potential economic transformation of clinical research in the coming decade.
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From page 191...
... 3000 2000 1000 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Year FIGURE 1 Possible improved productivity effects of health information technology. SOURCE: Adapted from Hillestad et al., 2005.
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From page 192...
... generated from lost productivity gains that would have been enabled by technology and business transformation over time. SOURCE: Kevin Schulman and Preethi Sama, Duke University.
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Key Terms

  • business model
  • business transformation
  • business models
  • transformed clinical
  • trials enterprise

  • research business
  • research environment
  • potential economic
  • research process
  • clinical data

  • clinical care
  • existing business
  • business processes
  • legacy costs
  • health information

  • information industries
  • cost trajectory
  • cal research
  • trials transformation
  • lost productivity

  • ness transformation
  • opportunity cost
  • productivity gains
  • breast cancer
  • clinical evidence

  • traditional clinical
  • sponsor clinical
  • clinical trial
  • duke clinical
  • gathering clinical


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