Elsevier

European Journal of Cancer

Volume 41, Issue 15, October 2005, Pages 2237-2240
European Journal of Cancer

Disclosure of competing financial interests and role of sponsors in phase III cancer trials

https://doi.org/10.1016/j.ejca.2004.12.036Get rights and content

Abstract

Financial relationships between industry, researchers and academic institutions are becoming increasingly complex, raising concern about sponsors’ involvement in the conduct of biomedical research. A review of published randomised trials (RCTs) in cancer research was performed to assess adherence to the 1997 disclosure requirements and to document the nature of the disclosed interests. Source(s) of study support, author–sponsor relationships and the role of the study sponsor were assessed for all RCTs published between 1999 and 2003 in 12 international journals. A total of 655 cancer RCTs were identified. Of these, 516 (78.8%) disclosed the source of sponsorship. The nature of the relationship between the authors and the study sponsor was included in 219 of the 227 industry-sponsored studies. The most commonly cited relationships were (131 studies had multiple relations): grants (93.6%); employment (39.2%); consultant/honorarium (12.7%) and stock ownership and participation in a speaker’s bureau (12, 5.5% each). Only 41 (18%) of the 227 industry-sponsored RCTs reported the role of the sponsor. Of these, 20 explicitly stated that the sponsor had no role in the study. Twenty-one papers described the sponsor’s role, the degree of sponsor involvement was variable and usually described vaguely. Among these papers, four stated that researchers had full access to all data, one that the researchers had no limits on publication and one that ‘the decision to submit the paper for publication was determined by the study sponsor’. In conclusion, no researcher should be expected to produce ‘findings’ without full access to the data, freedom from interference in analysis and interpretation and liberty to publish all results, however disappointing to the stakeholder they may be. In the meantime, researchers do well to arm themselves with the rules for research partnerships and editors to take on the role of watchdog.

Introduction

Conflict of interest has been defined as a set of conditions in which professional judgement concerning a primary interest (such as patient welfare or the validity of research) can be influenced by a secondary interest (such as financial gain) [1].

Financial relationships between industry, researchers and academic institutions are growing increasingly complex, raising concern about sponsors’ considerable, and perhaps inappropriate, involvement in the conduct of biomedical research 2, 3.

Editors have been concerned about this for a long time. In 1985, the International Committee of Medical Journals Editors produced a statement on conflicts of interest [4]. The 1997 Uniform Requirements for Manuscripts to Biomedical Journals [5] recommend that all published studies should include information on sources of funding, financial conflicts of interest of the authors, and specific descriptions of ‘the type and degree of involvement of the supporting agency’. For industry support, authors are asked to describe the sponsor’s role in the design, analysis and reporting of the study data [5]. If there has been no such involvement, the manuscript is expected explicitly to state this fact [5]. More than 500 journals subscribe to these requirements.

Previous work has shown that many published papers do not contain statements of financial competing interest [6]. However, little is known about authors’ adherence. It is not known whether these findings apply to cancer randomised controlled trials (RCTs).

Section snippets

Methods

All phase III cancer RCTs trials published in the following journals: New England Journal of Medicine, Lancet, British Medical Journal, Journal of the American Medical Association, British Journal of Cancer, Journal of Clinical Oncology, Lung Cancer, Annals of Oncology, European Journal of Cancer, Clinical Cancer Research, Cancer and Journal of National Cancer Institute from January 1999 to December 2003 were identified. To identify eligible articles, all issues of these journals were

Results

We identified 655 cancer RCTs: 280 (9.2%) in Journal of Clinical Oncology 72 (11%) in Cancer 60 (9.2%) in Annals of Oncology, 52 (8%) in Journal of National Cancer Institute, 48 (7.3%) in New England Journal of Medicine, 42 (6.4%) in Lancet, 38 (5.8%) in British Journal of Cancer, 28 (4.3%) in European Journal of Cancer, 16 (2.4%) in Lung Cancer, 12 (1.8%) in Clinical Cancer Research, 5 (0.8%) in Journal of the American Medical Association, and 2 (0.3%) in British Medical Journal. Of these, 516

Discussion

Financial and other competing interests have recently received increasing attention [28]. This concern has coincided with the reduced availability of public research funding, which has, in turn, resulted in scientist’s increasing reliance on industry support.

The costs of medical research have increased to levels that even the wealthiest university or co-operative group can no longer afford. Public funds cannot do the job; partnerships with industry are mandatory, but we have to manage them

Conflict of interest statement

None declared.

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