title: Clinical Trials in Precision Oncology.
abstract: BACKGROUND
  Availability of genomic information used in the management of cancer treatment has outpaced both regulatory and reimbursement efforts. Many types of clinical trials are underway to validate the utility of emerging genome-based biomarkers for diagnostic, prognostic, and predictive applications. Clinical trials are a key source of evidence required for US Food and Drug Administration approval of therapies and companion diagnostics and for establishing the acceptance criteria for reimbursement.
  
  
  BACKGROUND
  Determining the eligibility of patients for molecular-based clinical trials and the interpretation of data emerging from clinical trials is significantly hampered by 2 primary factors: the lack of specific reporting standards for biomarkers in clinical trials and the lack of adherence to official gene and variant naming standards. Clinical trial registries need specifics on the mutation required for enrollment as opposed to allowing a generic mutation entry such as, "EGFR mutation." The use of clinical trials data in bioinformatics analysis and reporting is also gated by the lack of robust, state of the art programmatic access support. An initiative is needed to develop community standards for clinical trial descriptions and outcome reporting that are modeled after similar efforts in the genomics research community.
  
  
  CONCLUSIONS
  Systematic implementation of reporting standards is needed to insure consistency and specificity of biomarker data, which will in turn enable better comparison and assessment of clinical trial outcomes across multiple studies. Reporting standards will facilitate improved identification of relevant clinical trials, aggregation and comparison of information across independent trials, and programmatic access to clinical trials databases.
authors.affiliation: The Jackson Laboratory for Genomic Medicine, Farmington, CT; susan.mockus@jax.org.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Mockus
authors.affiliation: The Jackson Laboratory for Genomic Medicine, Farmington, CT;
authors.forename: Sara E
authors.initials: SE
authors.lastname: Patterson
authors.affiliation: The Jackson Laboratory for Genomic Medicine, Farmington, CT;
authors.forename: Cara
authors.initials: C
authors.lastname: Statz
authors.affiliation: The Jackson Laboratory, Bar Harbor, ME;
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Bult
authors.affiliation: Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth, Lebanon, NH.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Tsongalis
mesh_terms: D014408:Biomarkers, Tumor; D002986:Clinical Trials as Topic; D018773:Genes, erbB-1 / Q000235:genetics; D014644:Genetic Variation; D006801:Humans; D011237:Predictive Value of Tests
chemical_list: D014408:Biomarkers, Tumor