Funding Source Influence on Clinical Trial Conclusions Hard To Escape By Rachael Myers Lowe, cancerpage.com (August 1, 2002) - Even when publishers enact stringent ethical guidelines requiring full discloser of potential conflicts of interest, reporting on clinical trial outcomes can be affected by the trial's funding source and analysts must be more sensitive to this inescapable fact when reviewing trial conclusions. That's the finding of a report in the August 3 edition of the British Medical Journal (BMJ). Danish researchers examined articles about 159 randomized trials covering numerous medical disciplines published between 1997 and 2001 in the British Medial Journal. They looked at who funded the studies and author conclusions about the experimental treatment being studied. Ninety-nine of the trials were investigating experimental drugs, the rest were non-pharmaceutical interventions. The researchers sought to identify any factors about a clinical trial that might cloud an author's professional judgment in reporting trial results. Such interests included financial, personal, academic and political influences. For-profit and not-for-profit funding sources were examined separately. Lise Kjaergard and Bodil Als-Nielsen of the Center for Clinical Intervention Research at Copenhagen University Hospital concluded that investigational treatments were "significantly" more likely to receive a favorable review in trials funded by for-profit organizations that stand to benefit financially from a favorable report. A weaker correlation was found between favorable conclusions and mixed funding sources or not-for-profit funding sources. Authors' conclusions were judged on a 6 point scale, where the experimental intervention is highly preferred and should be adopted as standard of care (6) to the control intervention is highly preferred and should be standard of care (1.) "Authors' conclusions in trials funded by for profit organizations alone significantly favoured experimental interventions compared with trials without competing interests, trials funded by both for profit and non profit organizations, and trials with other competing interests," the report stated. Furthermore, "the combined evidence supports suggestions that systematic reviews should include sensitivity analyses with regard to funding," the report concludes. Great efforts have been made in recent years to keep clinical trial reporting honest. Institutional Review Boards at research institutions guard patient safety and enforce ethical guidelines. And last year, a dozen of the most prestigious medical journals instituted policies to limit the pharmaceutical industry’s influence on reporting within their publications. The journal editors said at the time they were spurred into action by several examples in recent years of drug companies being accused of attempting to hide findings that were not to their liking or misrepresenting such results as positive. BMJ articles were chosen for this study because of the journal's clearly stated policy requiring authors to report conflicting interests. As a result, the authors suggest it's possible their findings under-report funding's impact on research findings. "It is possible that the requirement to disclose competing interests will discourage authors with competing interests from submitting biased trials to the BMJ. Accordingly, we may have underestimated the general association between competing interests and authors' conclusions," the report says. "Our findings may be relevant only to trials published in the BMJ, although we cannot identify any reason which this should be the case," the authors said. SOURCE: British Medical Journal 2002; 325: 249-252. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.