BOX 1-1

Speaker’s Perspectives on Barriers to the Collection of Clinical Validity and Utility Data for Genomic Diagnostic Tests

  • Various stakeholders require different types and levels of evidence (e.g., doc­tors, patients, FDA, payers, evidence-based review groups)

  • Limited or nonexistent funding for randomized controlled trials of genomic tests

  • Length of time needed for clinical trials to be completed

  • High cost of archiving specimens from therapeutic clinical trials

  • Lack of access to annotated clinical specimens

nisms to obtain it so that the promise of the human genome project and genomic diagnostic testing can be fully realized.

The report that follows summarizes the presentations and discussions by the expert panelists. Chapter 2 provides the different stakeholder perspectives on the type and level of evidence needed for decision making. Approaches for evidence generation are discussed in Chapter 3. Chapters 4 and 5 examine ways to overcome the barriers to evidence generation and strategies for moving forward. Final remarks are provided in Chapter 6, and the workshop agenda, biographical sketches of the panelists, and list of attendees are included in the appendixes.

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