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Neuro Oncol 2005 7(4):425-434; DOI:10.1215/S1152851705000554
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Editorials

GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies—reporting of phase 1 and phase 2 clinical trials

Susan M. Chang1, Sharon L. Reynolds, Nicholas Butowski, Kathleen R. Lamborn, Jan C. Buckner, Richard S. Kaplan and Darell D. Bigner

Department of Neurological Surgery, University of California San Francisco, San Francisco, CA 94143, USA (S.M.C., S.L.R, N.B., K.R.L.; Department of Oncology, Mayo Clinic Cancer Center; Rochester, MN 55905, USA (J.C.B.); National Cancer Research Network, Leeds LS16 6QB, UK (R.S.K.); Comprehensive Cancer Center, Duke University Medical Center, Durham, NC 27710, USA (D.D.B.)

1 Address correspondence to Susan M. Chang, Department of Neurological Surgery, University of California San Francisco, 400 Parnassus Ave., A 808, Box 0372, San Francisco, CA 94143-0372. (changs{at}neurosurg.ucsf.edu).

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.







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Copyright 2005 by Society for Neuro-Oncology