Self-Reported Conflicts of Interest of Authors, Trial
Sponsorship, and the Interpretation of Editorials and
Related Phase III Trials in Oncology
Giovanni M. Bariani, Anezka C.R. de Celis Ferrari, Paulo M. Hoff, Monika K. Krzyzanowska,
and Rachel P. Riechelmann
See accompanying editorial doi: 10.1200/JCO.2013.48.8817
Giovanni M. Bariani, Anezka C.R. de
Celis Ferrari, Paulo M. Hoff, and Rachel
P. Riechelmann, Instituto do Ca ˆncer do
Estado de Sa ˜o Paulo, Sa ˜ o Paulo, Brazil;
and Monika K. Krzyzanowska, Princess
Margaret Hospital, Toronto, Ontario,
Canada.
Published online ahead of print at
www.jco.org on April 29, 2013.
Presented at the 48th Annual Meeting
of the American Society of Clinical
Oncology, Chicago, IL, June 1-5, 2012.
Authors’ disclosures of potential con-
flicts of interest and author contribu-
tions are found at the end of this
article.
Corresponding author: Rachel P.
Riechelmann, MD, PhD, Clinical
Research Unit, Instituto do Ca ˆncer do
Estado de Sa ˜ o Paulo, Av. Dr. Arnaldo
251, 12° andar, 01246-000 Sa ˜o Paulo
SP, Brazil; e-mail: rachel.riechelmann@
icesp.org.br.
© 2013 by American Society of Clinical
Oncology
0732-183X/13/3199-1/$20.00
DOI: 10.1200/JCO.2012.46.6706
A B S T R A C T
Purpose
Growing participation by industry in cancer research has resulted in increased reporting of conflicts
of interest (COI). We aimed to test any association between authors’ conclusions and self-
reported COI or trial sponsorship in cancer studies.
Methods
Editorials and related phase III trials published in six clinical oncology journals in the last 3.5 years
were analyzed independently by two investigators who classified study conclusions according to
authors’ endorsement of the experimental therapy. Logistic regression multivariable models were
used to assess predictors of favorable conclusions of editorialists and of phase III authors.
Results
From January 2008 to October 2011, 1,485 articles were retrieved: 150 phase III trials and 150
editorials were eligible. Among the phase III trials, 82 (54.7%) had positive results, and 78 (52.0%)
were entirely or partially funded by industry. Any COI were disclosed in 103 phase III trials (68.7%)
and in 71 editorials (47.3%). Multivariable analysis showed that phase III trial results were the only
significant predictor for a positive conclusion by trial authors (odds ratio [OR], 92.2; 95% CI, 19.7
to 431.6; P .001). Sponsorship did not predict for positive conclusion by phase III authors (OR,
0.86; 95% CI, 0.3 to 2.5; P = .788). The only factor associated with positive conclusions by
editorial authors was a positive conclusion by phase III trial authors (OR, 36.3; 95% CI, 6.8 to
194.2; P .001).
Conclusion
The interpretation of recently published phase III cancer trials by their authors or by editorialists
was not influenced by financial relationships or industry sponsorship. Increased awareness of COI
policies may have led to more integrity in cancer research reporting.
J Clin Oncol 31. © 2013 by American Society of Clinical Oncology
INTRODUCTION
Pharmaceutical industry collaboration in clinical re-
search has increased over time,
1
particularly in on-
cology.
2
Performing cancer clinical trials requires
significant financial resources, which makes indus-
try sponsorship almost a necessity. Likewise, newly
approved cancer drugs are expensive, making the
development of cancer drugs an attractive field for
industry investment. Consequently, financial ties
between sponsors and investigators have become
common in oncology. In a cross-sectional survey of
studies published in the Journal of Clinical Oncology
(JCO) in 2005, at least one financial relationship
between authors and pharmaceutical companies
was disclosed in 69% of trials and in 51% of editori-
als.
3
Another study showed that 58% of trials pub-
lished in JCO in 2005 and 2006 had at least one
author who disclosed any monetary relationship
with industry.
4
Obviously, such widespread finan-
cial ties of authors with industry have concerned the
community about their influence on research devel-
opment and interpretation.
5-7
Conflicts of interest (COI) is a widely used term
to denote the presence of secondary interests, usu-
ally financial, between industry and authors of clin-
ical research.
8
Since 1997, the International
Committee of Medical Journal Editors has rec-
ommended the publication of source of funding
and financial ties between authors and sponsors
in an attempt to control for bias.
9
However, COI
of investigators with for-profit organizations have
JOURNAL OF CLINICAL ONCOLOGY
O R I G I N A L R E P O R T
© 2013 by American Society of Clinical Oncology 1
http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2012.46.6706 The latest version is at
Published Ahead of Print on April 29, 2013 as 10.1200/JCO.2012.46.6706
Copyright 2013 by American Society of Clinical Oncology