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.
"Our access to trial protocols gave us additional information on sponsor involvement not possible to decipher from the published papers alone. A study of cancer trials found that only 18% of the industry-sponsored trials described the sponsors’ role and usually in vague terms . There are some limitations that should be taken into account though. "
[Show abstract][Hide abstract] ABSTRACT: Background
Bias in industry-sponsored trials is common and the interpretation of the results can be particularly distorted in favour of the sponsor’s product. We investigated sponsors’ involvement in the conduct and reporting of industry-sponsored trials.
We included all industry-sponsored trials published in The Lancet in 2008 and 2009 and corresponding trial protocols provided by The Lancet. For each protocol and publication, we extracted information on trial conduct and reporting.
We identified 169 publications of randomised trials and included 69 (41%) that were industry-sponsored, and 12 (7%) industry-funded but seemingly independently conducted as a subsample. Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. In 11 of the trials, there was a discrepancy between the information in the protocols and papers concerning who analysed the data. In four of the 12 seemingly independent trials, the protocol described sponsors’ involvement in writing the report while the published paper explicitly stated that the sponsor was not involved.
The sponsors are usually involved in the analysis and reporting of results in industry-sponsored trials, but their exact role is not always clear from the published papers. Journals should require more transparent reporting of the sponsors’ role in crucial elements such as data processing, statistical analysis and writing of the manuscript and should consider requiring access to trial protocols, independent data analysis and submission of the raw data.
"The answer is we do not know, unless this is disclosed as is part of an author's statement when neuropsychological research and publishing occurs with data gathered from a forensic setting. Our colleagues in other research areas have recognized this problem and require full disclosure (Boyd, Cho, & Bero, 2003; Buchkowsky & Jewesson, 2004; Charlton, 2005; Gilbody, House, & Sheldon, 2002; Grant & Iserson, 2005; Kanauss et al., 2005; Kielbasa et al., 2004; Marco & Larkin, 2000; Tuech et al., 2005). Journals that publish articles in neuropsychology, especially those journals that focus on forensic topics, should have a full disclosure policy with data publicly available so these COI issues can be scientifically addressed. "
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