Archive

Archive for May, 2009

Clinical trials and Cancer drugs

May 26th, 2009

Another recent (and disturbing) study about the scope of COI in clinical trials has appeared in the journal Cancer. Such empirical studies are an important contribution to a developing literature on COI, and a critical step in building the evidence base necessary to justify the ethical and policy arguments for the need to deal clearly with COI in academic research. As the authors of this study note (quoted from the following news story: 29 Percent Of Cancer Studies Report Conflict Of Interest.),

“Given the frequency we observed for conflicts of interest and the fact that conflicts were associated with study outcomes, I would suggest that merely disclosing conflicts is probably not enough. It’s becoming increasingly clear that we need to look more at how we can disentangle cancer research from industry ties,” says study author Reshma Jagsi, M.D., D.Phil., assistant professor of radiation oncology at the U-M Medical School.

For a smart analysis of the challenges of managing COI in bioscience research, and the importance of developing empirical evidence on the subject, see this this blog post by Patti Tereskerz, “Can We Bank on Objectivity? Proposed NIH Rules Aim to Curb Influence of Industry Dollars“, over at Science Progress.

Bryn Williams-Jones

DHHS Consultation

May 14th, 2009

So it looks like the U.S. Department of Health and Human Services is thinking about redoing its COI policy: HHS Considers Revising Financial Conflict-of-Interest Rules. According to this story, the NIH will be soliciting comments on the following topics:

• expansion of the scope of the regulation and disclosure of interests;
• definition of “significant financial interest”;
• identification and management of conflicts by institutions;
• assurance of institutional compliance;
• provision of additional information to federal officials by research institutions; and
• broadening of the regulations to address institutional conflicts of interest

Given the ambiguity of current US Federal guidelines (particularly with regards to “Significant Financial Interests”), a broad public consultation and review can only be a good thing.

Bryn Williams-Jones