| Reporting of studies on new medicines in major medical journals: a case study in breast cancer. | |
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MedLine Citation:
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PMID: 20305673 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A comparison of the results of pivotal trials on three new medicines for advanced breast cancer published in medical journals with those presented in the US Food and Drug Administration (FDA) reviews showed that analyses reported in journals were of lower quality and were given a favorable interpretation by minimizing toxicity and ignoring methodological shortcomings. Several proposals to strengthen the quality of reporting of clinical trials in medical journals and to support reliable assessment of the therapeutic value of new medicines are discussed. |
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Authors:
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A I Vitry |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 87 ISSN: 1532-6535 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-03-22 Completed Date: 2010-04-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: United States |
Other Details:
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Languages: eng Pagination: 398-400 Citation Subset: AIM; IM |
Affiliation:
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Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia, Australia. agnes.vitry@unisa.edu.au |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antibodies, Monoclonal
/
adverse effects,
therapeutic use Antineoplastic Agents / administration & dosage, adverse effects, therapeutic use Breast Neoplasms / drug therapy* Clinical Trials as Topic / methods*, standards Female Humans Paclitaxel / administration & dosage, adverse effects, therapeutic use Periodicals as Topic* Quinazolines / adverse effects, therapeutic use United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 0/Antineoplastic Agents; 0/Quinazolines; 0/bevacizumab; 0/lapatinib; 33069-62-4/Paclitaxel |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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