title: Genomics-based early-phase clinical trials in oncology: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.
abstract: The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force discussed incorporation of genomic profiling into early (Phase I and II) clinical trials in oncology. The task force reviewed the challenges of standardising genomics data in a manner conducive to conducting clinical trials. Current barriers to successful and efficient implementation were identified and discussed, as well as the methods of genomic analysis, the proper setting for study and strategies to facilitate timely completion of genomics-based studies. The importance of properly capturing and cataloguing outcomes was also discussed. Several recommendations regarding the use of genomics in these trials are provided.
authors.affiliation: Georgetown University, Washington, DC, USA.
authors.forename: Stephen V
authors.initials: SV
authors.lastname: Liu
authors.affiliation: Foundation Medicine, Cambridge, MA, USA.
authors.forename: Vincent A
authors.initials: VA
authors.lastname: Miller
authors.affiliation: NDDO Education Foundation, Amsterdam, The Netherlands.
authors.forename: Marinus W
authors.initials: MW
authors.lastname: Lobbezoo
authors.affiliation: Georgetown University, Washington, DC, USA.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
mesh_terms: D026683:Advisory Committees; D002986:Clinical Trials as Topic; D015894:Genome, Human; D023281:Genomics; D006801:Humans; D020714:Maximum Tolerated Dose; D008495:Medical Oncology / Q000379:methods* / Q000458:organization & administration; D009369:Neoplasms / Q000628:therapy*; D015398:Signal Transduction; D035703:Therapies, Investigational / Q000379:methods; D016896:Treatment Outcome
keywords: Clinical trials; Genomics; Phase I