Disclosure of competing financial interests and role of sponsors in phase III cancer trials
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.
References (32)
- et al.
Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial
Ann Oncol
(2002) - et al.
Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group
Eur J Cancer
(1999) - et al.
Edrecolomab alone or in combination with fluorouracil and folinic acid in the adjuvant treatment of stage III colon cancer: a randomised study
Lancet
(2002) - et al.
Sponsorship, authorship, and accountability
Lancet
(2001) Understanding financial conflicts of interest
N Engl J Med
(1993)Ethics issues in academic industry relationships in the life science
Acad Med
(1996)Uneasy alliance – clinical investigators and the pharmaceutical industry
N Engl J Med
(2000)Conflict of interest
Lancet
(1993)Uniform requirements for manuscripts submitted to biomedical journals
Ann Intern Med
(1997)- et al.
Declaring financial competing interests: survey of five general medical journals
BMJ
(2001)
Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: the ICON3 randomised trial
Lancet
Prospective, double-blind, placebo-controlled randomized trial of cimetidine in gastric cancer. British Stomach Cancer Group
Brit J Cancer
Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial
Brit J Cancer
Epoetin Alfa Study Group. Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial
J Clin Oncol
Treatment of former smokers with 9-cis-retinoic acid reverses loss of retinoic acid receptor-beta expression in the bronchial epithelium: results from a randomized placebo-controlled trial
J Natl Cancer Inst
Superiority of oxaliplatin and fluorouracil–leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil–leucovorin: interim results of a phase III trial
J Clin Oncol
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