Tuesday, July 20, 2010

Are DSMBs Independent? NEJM Worries Not

In previous posts, such as:
http://brodyhooked.blogspot.com/2009/11/no-fair-peeking-more-questions-about.html

--I have expressed the opinion and concern that the data safety and monitoring boards (DSMBs) that are supposed to be an independent check on the conduct of a randomized controlled trial--for example, stopping a trial early if there is excess mortality among one study group--may not be as independent from the commercial sponsor of a trial as is officially stated. The reasons I thought this might be true were:
  • Anecdotal comments from friends closer to the ethical review of clinical trials than I am
  • The strange coincidence that a number of recent decisions by DSMBs to stop trials early seemed suspiciously favorable to the marketing aims of the drug company paying for the trial
As neither of the above is any sort of solid evidence, I had no really good grounds to express concerns. I therefore am happy to see that I appear to be in good company. The New England Journal of Medicine (subscription required) has published an editorial on-line by its editor, Dr. Jeffrey Drazen, and by drug industry expert Dr. Alastair J.J. Wood. The editorial describes two specific instances in which the integrity of the DSMB process appears to have been compromised. The editorialists therefore call for new steps to assure stricter firewalls between the management of the DMSB and the trial sponsor. They conclude, "For too long, sponsors of trials have considered the DSMB a necessary nuisance whose strings they can pull at will."

Drazen JM, Wood AJJ. Don't mess with the DSMB [editorial]. New England Journal of Medicine (10.1056/NEJMe1007445), epub July 7, 2010.

2 comments:

marilynmann said...

Howard,

I don't understand the title to your post. The point of the editorial is that the editors to the NEJM *are* worried about the independence of DSMBs.

Marilyn

Howard Brody said...

Sorry, Marilyn, I was trying to be too clipped. The title was meant to be read as, “Are DSMBs Independent? NEJM Worries THAT THEY ARE Not.” Thanks for writing, Howard