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Generating Evidence for Genomic Diagnostic Test Development Workshop Summary (2011) / Chapter Skim
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5 Considerations Moving Forward
Pages 53-58

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From page 53...
... In light of the barriers and complexities associated with the various models of evidence generation discussed and of the need for more timely evidence gathering in order to better meet the needs of patients and providers, the workshop participants considered what the next steps should be in generating new evidence for the development of genomic diagnostic tests. MEDICAL PRACTICE VERSUS EVIDENCE-BASED RECOMMENDATIONS Roger Klein, a member of EGAPP, asked why medical practice often diverges from the recommendations issued by evidence-based review groups.
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From page 54...
... For example, FDA recently cleared the breast cancer recurrence test, MammaPrint, for more broad use in all age groups, while the Blue Cross and Blue Shield Association TEC determined that Oncotype DX met its criteria but MammaPrint did not, and EGAPP has concluded there is insufficient evidence to recommend for or against either test. Piper responded that the Oncotype DX test was reviewed by TEC several times, and the final vote to cover the test was very close.
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From page 55...
... Hayes explained that ASCO's Oncotype DX decision was based on the review of studies that asked clinically relevant questions regarding node-negative, estrogen receptor–positive women and tamoxifen that were applicable to practice. Becker said that one of the most important differences between the tests was the fact that Oncotype DX claimed to be able to therapeutically manage patients, while MammaPrint could not specifically make that claim.
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From page 56...
... It will also be important to compare these questions with the priorities of the medical system at large, one participant commented. The point was made again that the success of Oncotype DX was due to the fact that the clinical question came first, then the developer figured out what kind of dataset was needed to answer the question and found the most appropriate previously conducted clinical trial.
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From page 57...
... The Consolidated Standards of Reporting Trials have helped to ensure transparency in clinical trial reporting, as have the requirements by many journals that authors provide details about basic research studies, such as the specific reagents used. But for some reason, the translational area in between basic and clinical research has been left behind.
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From page 58...
... It was further suggested that the roundtable engage major journal editors and urge them to pay more attention to tumor marker studies with regard to design, quality, and transparency. PUBLIC EXPECTATIONS Participants discussed the need for a public education effort regarding genomic interventions.
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Key Terms

  • clinical trials
  • diagnostic test
  • clinical trial
  • clinical utility
  • fda clearance

  • blue cross
  • medical practice
  • evidence generation
  • blue shield
  • test result

  • help close
  • genetic alliance
  • appropriate treatment
  • recurrence test
  • timely evidence

  • tions outside
  • relevant questions
  • protocols publicly
  • participants discussed
  • participant noted

  • shield plans
  • help define
  • fda requires
  • generation discussed
  • moderator sharon

  • treatment decisions
  • complexities associated
  • manage patients
  • diagnostic tests
  • insufficient evidence


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