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 manu...

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Bibliographic Details
Published in:Neuro-oncology (Charlottesville, Va.) Va.), 2005-10, Vol.7 (4), p.425-434
Main Authors: Chang, Susan M, Reynolds, Sharon L, Butowski, Nicholas, Lamborn, Kathleen R, Buckner, Jan C, Kaplan, Richard S, Bigner, Darell D
Format: Article
Language:English
Subjects:
Clinical Trials, Phase I as Topic - standards
Clinical Trials, Phase II as Topic - standards
Data Interpretation, Statistical
Humans
Nervous System Neoplasms - therapy
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Summary: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.
ISSN:1522-8517
1523-5866
DOI:10.1215/S1152851705000554