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

Laboratoire d'Ethique Médicale et Médecine Légale, Faculté de Médecine de Paris 5, 45 rue des Saints-Pères, 75006 Paris, France.
European Journal of Cancer (Impact Factor: 4.82). 11/2005; 41(15):2237-40. DOI: 10.1016/j.ejca.2004.12.036
Source: PubMed

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.

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    ABSTRACT: BACKGROUND: It is unknown whether changes in study sponsorship have affected the proportion of prospective research on surgery, radiotherapy, and pharmacotherapy for head and neck squamous cell carcinoma (HNSCC) being published over time. PATIENTS AND METHODS: We examined prospective studies from PubMed, Ovid MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from 1980, 1985, 1990, 1995, 2000, 2005, and 2010. Chi-squared tests were used to identify significant associations between sponsorship and authorship, treatments within study protocols, and presentation of results, whereas time-based trends were analyzed using the Cochran-Armitage test. RESULTS: Among 309 articles, industry (70, 22.7%) and the U.S. Government (65, 21%) were the most common sponsors. There was a significant increase in the proportion of industry-sponsored research (p for trend = .013) and a decline in U.S. government-sponsored research (p for trend = .001) over time. The inclusion of surgery in treatment protocols declined over the past four decades (p for trend = .003). Protocols incorporating pharmacotherapy were more likely to have industry support than those without pharmacotherapy (p = .001), whereas protocols with radiotherapy (p = .003) or surgery (p = .002) were less likely to have industry support. CONCLUSION: Industry is the predominant sponsor of prospective HNSCC research, with an emphasis on pharmacotherapy.
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