title: How comparative effectiveness research can help advance 'personalized medicine' in cancer treatment.
abstract: The use of biomarkers to "personalize" cancer treatment--identifying discrete genes, proteins, or other indicators that can differentiate one type of cancer from another and enable the use of highly tailored therapies--offers tremendous potential for improved outcomes and lower treatment costs. However, the rapid development of cancer biomarker, or genomic, tests--combined with a paucity of evidence to support the effectiveness of the tests--presents a challenge for patients, clinicians, and other stakeholders. In this article we propose that comparative effectiveness research be used to strengthen what is now a haphazard process for developing and marketing cancer biomarker tests. We suggest novel funding approaches and a systematic process for moving from regulatory approval to the generation of evidence that meets the needs of stakeholders and, ultimately, patients.
authors.affiliation: Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. sramsey@fhcrc.org
authors.forename: Scott D
authors.initials: SD
authors.lastname: Ramsey
authors.forename: David
authors.initials: D
authors.lastname: Veenstra
authors.forename: Sean R
authors.initials: SR
authors.lastname: Tunis
authors.forename: Louis
authors.initials: L
authors.lastname: Garrison
authors.forename: John J
authors.initials: JJ
authors.lastname: Crowley
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Baker
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D002986:Clinical Trials as Topic; D057186:Comparative Effectiveness Research; D023281:Genomics; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D057285:Precision Medicine; D014481:United States
chemical_list: D014408:Biomarkers, Tumor