GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials.
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.
Chang
Susan M
SM
Department of Neurological Surgery, University of California, San Francisco, CA 94143, USA. changs@neurosurg.ucsf.edu
Reynolds
Sharon L
SL
Butowski
Nicholas
N
Lamborn
Kathleen R
KR
Buckner
Jan C
JC
Kaplan
Richard S
RS
Bigner
Darell D
DD
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*