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