Literature DB >> 16212807

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, Darell D Bigner.   

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.

Mesh:

Year:  2005        PMID: 16212807      PMCID: PMC1871726          DOI: 10.1215/S1152851705000554

Source DB:  PubMed          Journal:  Neuro Oncol        ISSN: 1522-8517            Impact factor:   12.300


  22 in total

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Authors: 
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Review 5.  Primary and secondary glioblastomas: from concept to clinical diagnosis.

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Review 7.  Interactions between antiepileptic and chemotherapeutic drugs.

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8.  Prognostic factors for survival of patients with glioblastoma: recursive partitioning analysis.

Authors:  Kathleen R Lamborn; Susan M Chang; Michael D Prados
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Authors:  Michael D Prados; W K A Yung; Kurt A Jaeckle; H Ian Robins; Minesh P Mehta; Howard A Fine; Patrick Y Wen; Timothy F Cloughesy; Susan M Chang; M Kelly Nicholas; David Schiff; Harry S Greenberg; Larry Junck; Karen L Fink; Kenneth R Hess; John Kuhn
Journal:  Neuro Oncol       Date:  2004-01       Impact factor: 12.300

10.  [The new WHO classification of tumors of the nervous system 2000. Pathology and genetics].

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Journal:  Pathologe       Date:  2002-07       Impact factor: 1.011

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  11 in total

1.  Quality assessment of phase I dose-finding cancer trials: proposal of a checklist.

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3.  The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

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5.  Pediatric phase II trials of poly-ICLC in the management of newly diagnosed and recurrent brain tumors.

Authors:  Lisa L R Hartman; John R Crawford; Milan T Makale; Mehrzad Milburn; Shweta Joshi; Andres M Salazar; Beth Hasenauer; Scott R VandenBerg; Tobey J MacDonald; Donald L Durden
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6.  GNOSIS: guidelines for neuro-oncology: standards for investigational studies--reporting of surgically based therapeutic clinical trials.

Authors:  Susan Chang; Michael Vogelbaum; Frederick F Lang; Stephen Haines; Sandeep Kunwar; E Antonio Chiocca; Alessandro Olivi; Alfredo Quinones-Hinojosa; Andrew Parsa; Ronald Warnick
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7.  Real-world validity of randomized controlled phase III trials in newly diagnosed glioblastoma: to whom do the results of the trials apply?

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Review 9.  Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review.

Authors:  Luca G Campana; A James P Clover; Sara Valpione; Pietro Quaglino; Julie Gehl; Christian Kunte; Marko Snoj; Maja Cemazar; Carlo R Rossi; Damijan Miklavcic; Gregor Sersa
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Review 10.  Reporting guidelines for oncology research: helping to maximise the impact of your research.

Authors:  Angela MacCarthy; Shona Kirtley; Jennifer A de Beyer; Douglas G Altman; Iveta Simera
Journal:  Br J Cancer       Date:  2018-02-22       Impact factor: 7.640

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