"Don't Mess with the DSMB"

I quote the opening of an editorial in the New England Journal of Medicine.

If the lyrics of the popular Jim Croce song from the early 1970s were adapted for a clinical trialist anthem, the refrain would likely be

You don't tug on Superman's cape

You don't spit into the wind

You don't pull the mask off that old Lone Ranger

And you don't mess around with the DSMB.

Since the DSMB (data and safety monitoring board) is charged with ensuring that clinical equipoise is maintained as trial data are accrued, it is considered very bad, even self-destructive, behavior for people who are involved with the study to interact with DSMB members on trial-related issues. Traditionally, there has been a wall between investigators, sponsors, and the DSMB.This wall prevents preliminary findings from leaking out in ways that would prejudice the trial. For example, if it was known that the DSMB was examining a marginal increase in cardiovascular risk in a trial, then trial investigators might bias future recruitment by excluding patients at risk for such events. In the proper performance of clinical trials, you "don't mess around with the DSMB."

Recently, a new type of problem has emerged that puts the integrity of the whole clinical-trial enterprise at risk. Two examples of this problem have appeared in the Journal in the past few years. In these cases, the integrity of the DSMB has been thwarted or violated.