Document Detail


Bone pain from granulocyte colony stimulating factor: does clinical trial sponsorship by a pharmaceutical company influence its reporting?
MedLine Citation:
PMID:  19708947     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
It is alleged that pharmaceutical companies sometimes unfairly present clinical trial results. To our knowledge, studies have not explored whether such alleged unfair reporting also occurs in the testing of palliative care agents in cancer patients, a particularly vulnerable group. Therefore, a systematic search was conducted to retrieve all published, prospective clinical trials that used granulocyte colony stimulating factor starting in 2003. Because granulocyte colony stimulating factor can cause severe bone pain - a concerning but historically under-reported symptom in cancer patients - this symptom was assessed to determine whether differences in reporting occurred based on pharmaceutical company-sponsorship. A total of 239 published clinical trials met the present study's eligibility criteria and were retrievable. Within this entire group of studies, 65 (27%) were pharmaceutical company-sponsored, and only 31 (13%) reported on bone pain. However, pharmaceutical company-sponsored trials reported on bone pain at a higher rate compared with other studies: 23% versus 9% (P= 0.005), and this conclusion did not change after adjusting for dose, use of the slow release formulation and year of publication. The reporting of adverse events from cancer symptom control and palliative care interventions should be improved - especially in trials not sponsored by pharmaceutical companies.
Authors:
Y Aldairy; P L Nguyen; A Jatoi
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  European journal of cancer care     Volume:  20     ISSN:  1365-2354     ISO Abbreviation:  Eur J Cancer Care (Engl)     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2010-12-20     Completed Date:  2011-05-25     Revised Date:  2014-06-19    
Medline Journal Info:
Nlm Unique ID:  9301979     Medline TA:  Eur J Cancer Care (Engl)     Country:  England    
Other Details:
Languages:  eng     Pagination:  72-6     Citation Subset:  N    
Copyright Information:
© 2009 The Authors. European Journal of Cancer Care © 2009 Blackwell Publishing Ltd.
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MeSH Terms
Descriptor/Qualifier:
Bone Diseases / chemically induced*
Clinical Trials as Topic / standards*
Drug Industry*
Granulocyte Colony-Stimulating Factor / adverse effects*,  therapeutic use
Humans
Neoplasms / drug therapy*
Pain / chemically induced*
Prospective Studies
Research Support as Topic*
Grant Support
ID/Acronym/Agency:
K24 CA131099/CA/NCI NIH HHS; K24 CA131099-04/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
143011-72-7/Granulocyte Colony-Stimulating Factor

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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