title: GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials.
abstract: We present guidelines to standardize the reporting of phase 1 and phase 2 neuro-oncology trials. The guidelines are also intended to assist with accurate interpretation of results from these trials, to facilitate the peer-review process, and to expedite the publication of important and accurate manuscripts. Our guidelines are summarized in a checklist format that can be used as a framework from which to construct a phase 1 or 2 clinical trial.
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, CA 94143, USA. changs@neurosurg.ucsf.edu
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Reynolds
authors.forename: Nicholas
authors.initials: N
authors.lastname: Butowski
authors.forename: Kathleen R
authors.initials: KR
authors.lastname: Lamborn
authors.forename: Jan C
authors.initials: JC
authors.lastname: Buckner
authors.forename: Richard S
authors.initials: RS
authors.lastname: Kaplan
authors.forename: Darell D
authors.initials: DD
authors.lastname: Bigner
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000592:standards*; D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D003627:Data Interpretation, Statistical; D006801:Humans; D009423:Nervous System Neoplasms / Q000628:therapy*