title: Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies.
abstract: OBJECTIVE
  Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Understanding stakeholders' assessment of the current evidence base for clinical practice and coverage decisions should be a critical step in influencing research, policy, and practice.
  
  
  METHODS
  Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test.
  
  
  RESULTS
  At baseline, the level of confidence in the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for epidermal growth factor receptor mutation and Lynch syndrome testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX, intermediate levels of confidence for [corrected] epidermal growth factor receptor mutation testing and stable levels of confidence [corrected] for Lynch syndrome testing. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach.
  
  
  CONCLUSIONS
  Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis.
authors.affiliation: Center for Medical Technology Policy, Baltimore, MD, USA.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Deverka
authors.forename: Sheri D
authors.initials: SD
authors.lastname: Schully
authors.forename: Naoko
authors.initials: N
authors.lastname: Ishibe
authors.forename: Josh J
authors.initials: JJ
authors.lastname: Carlson
authors.forename: Andrew
authors.initials: A
authors.lastname: Freedman
authors.forename: Katrina A B
authors.initials: KA
authors.lastname: Goddard
authors.forename: Muin J
authors.initials: MJ
authors.lastname: Khoury
authors.forename: Scott D
authors.initials: SD
authors.lastname: Ramsey
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000235:genetics; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000235:genetics; D003123:Colorectal Neoplasms, Hereditary Nonpolyposis / Q000175:diagnosis* / Q000235:genetics; D003657:Decision Making; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D005820:Genetic Testing / Q000379:methods*; D023281:Genomics / Q000379:methods*; D006801:Humans; D009154:Mutation; D017410:Practice Guidelines as Topic; D015203:Reproducibility of Results
chemical_list: C512478:EGFR protein, human; D066246:ErbB Receptors