If you follow this topic long enough, after a while you start to wonder if they're republishing studies about the relationship between pharmaceutical industry support and clinical trials. You know you've seen this before.
A study released this month looked at 235 cancer drug trials over an 18-month period in the Journal of Clinical Oncology.1 It tested the hypothesis that authors who play key scientific roles in such trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. Their conclusion: Authors who perform the designated key roles were four times more likely than authors who have less influential roles to have financial ties to industry. This relationship was present whether the study was sponsored or not but was stronger for industry-sponsored trials.
Now, is that glass half-empty or half-full? Industry support of drug trials is the new normal; indeed many worthwhile studies would never occur without industry support.
And in every medical specialty today, the leading lights tend to be physicians and researchers who have ties to industry. But simple disclosure of industry relationships and support is not enough. Without fuller disclosure of the dollar amount of support, other non-cash benefits provided, and industry's influence on the study and its publication, questions remain. As the author of this study said, "The potential for bias appears to be even greater than was previously thought."
On the final point, the influence on publication, this profession provides a disturbing example of the need for caution.
Last January, researchers at the
In the 29 industry-supported trials, the published abstract conclusion was not consistent with the results of the main outcome measure in 62 percent of the articles; in the 10 non-industry-supported articles, no inconsistency was found. Worse, while just 24 percent of the industry-funded publications had a statistically significant main outcome measure, 90 percent of these had what the authors called "proindustry abstract conclusions."
1. JCO Jan 11 2010: doi:10.1200/JCO.2008.21.6606
2. Am J Ophthalmol 2009;147:33–38