Importance of DSMBs Posted on November 21, 2007 Alan F. Schatzberg (bio) examines the origin and purpose of the DSMB.

There are a number of issues that were thought to be best handled by having a separate group that could in fact monitor the study, particularly to determine whether adverse events had happened. Now, those that came out of — those were psychiatric examples, but there were others with gene therapy that came out of medicine and so there was a sense of usefulness for applying NIH funded studies. It’d been really around for a while in modest scale drug trials of pharmaceutical industry.

Around two issues, one, about looking at side effects and the risk-benefit ratio and two, at times in life threatening illnesses that might not have other treatments if a study was so positive that ethically it didn’t make sense to withhold people from the treatment or withhold people who were assigned the placebo that in fact one should go on and stop the study and just treat people. So, they were started. The NIMH has a DSMB for large scale trials and they have a variety of people who serve on it and they review kinds of — the data and the protocols et cetera. And local institutions will have them, and then some institutions, frequently if one is doing a study, one could set up one’s own DSMB and there are guidelines from it from the NIH or whatever.

So, we have a smoking cessation study that involves a an approved drug with an experiment use and we have a DSMB that is consisted of nationally well-known people who have some experience either in the area with that particular drug, who can in fact look at the data and comment as to whether there’s been an adverse event or if it’s risky or whatever, so it’s very, very helpful they usually meet a few times a year. Usually, virtually, you know, electronically, on the phone and they provide a feedback to the investigators. So, it’s useful.

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