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Generating Evidence for Genomic Diagnostic Test Development Workshop Summary (2011) / Chapter Skim
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6 Final Remarks
Pages 59-62

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From page 59...
... . With these perspectives and those given by other stakeholders during the workshop in mind, participants reviewed a variety of approaches to evidence generation, such as clinical trials, retrospective analysis of archived specimens, coverage with evidence development, and chains of evidence and analytic frameworks, and offered ideas and strategies that could help move evidence generation for genomic diagnostic test development forward.
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From page 60...
... Reimbursement and Coverage • D iscuss new economic/reimbursement models that place value on tests that can help identify when a particular treatment will not be beneficial and thereby prevent unnecessary costly therapeutic interventions. • D iscuss implementation of a system that does not pay for treatment if a prognostic or predictive genomic test is available and the results of that test do not support treatment in the patient.
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From page 61...
... • D iscuss with journal editors the importance of transparency in the reporting of diagnostic test validation studies toward establishing a strong, unbiased evidence base. Journals should publish only vali dation studies that meet study design quality criteria, and results should be published regardless of whether the outcome is positive or negative.
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From page 62...
... Identify the incentives for aligning these stakeholders in order to leverage specific clinical experiences and develop novel research initiatives. • T rain clinical investigators in diagnostic test development and in study design options and optimization.
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Key Terms

  • test development
  • genomic diagnostic
  • medical practice
  • genomic test
  • clinical trial

  • study design
  • evidence generation
  • trial specimens
  • genomic application
  • specific clinical

  • predictive genomic
  • controlled clinical
  • appropriate treatment
  • unbiased evidence
  • novel research

  • versus conducting
  • based review
  • research initiatives
  • participants reviewed
  • clinical experiences

  • archived specimens
  • leverage specific
  • develop novel
  • facilitating controlled
  • clinical trials

  • design quality
  • versus harms
  • supporting data
  • validation studies
  • analytic frameworks


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