Document Detail


Presentation of nonfinal results of randomized controlled trials at major oncology meetings.
MedLine Citation:
PMID:  19620490     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To assess the frequency, implications, and factors associated with reporting nonfinal analyses (NFAs) of randomized controlled trials (RCTs) as abstract publications. METHODS: We identified 138 consecutive reports of RCTs testing systemic therapy for lymphoma, breast, colorectal, or non-small-cell lung cancer published in six major journals between 2000 and 2004. We then searched proceedings of seven major cancer meetings, 1990 to 2004, for abstracts related to these publications which presented efficacy results. Articles and abstracts were compared for discordance in sample size, median follow-up, results, and conclusions. Abstracts were evaluated for statements explicitly noting or implying that results were not final. Factors associated with discordance were assessed by uni- and multivariate analyses. RESULTS: We identified 303 related abstracts; 197 were eligible. In 86 abstracts (44%), results were stated or implied to be NFA; this was explicitly stated in 41 (21%). The NFAs included 12 where accrual was ongoing. Discordance with article was found in 124 abstracts (63%) and was more common with NFAs (67 of 86 [78%] v 57 of 111 [51%]; P = .0001). When compared with articles, authors' conclusions were substantively different in 17 abstracts (10%). Factors most associated with data discordance were lymphoma trial (odds ratio [OR], 3.8; 95% CI, 1.5 to 10.8), cooperative group trial (OR, 2.8; 95% CI, 1.4 to 5.6), and presentation of a NFA (OR, 2.9; 95% CI, 1.5 to 5.8). CONCLUSION: Meeting abstracts often include NFAs and are frequently discordant with subsequent article publication.
Authors:
Christopher M Booth; Aurélie Le Maître; Keyue Ding; Kristen Farn; Michael Fralick; Cameron Phillips; David W Cescon; Ralph M Meyer
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-07-20
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  27     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-19     Completed Date:  2009-09-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3938-44     Citation Subset:  IM    
Affiliation:
National Cancer Institute of Canada Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. boothc@kgh.kari.net
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MeSH Terms
Descriptor/Qualifier:
Abstracting and Indexing as Topic*
Breast Neoplasms / therapy
Colorectal Neoplasms / therapy
Congresses as Topic*
Humans
Lung Neoplasms / therapy
Lymphoma / therapy
Neoplasms / therapy*
Publishing*
Randomized Controlled Trials as Topic*

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


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