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Protocol design and subject safety above the fold

One of the IRB’s criteria for approval of research is “Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.

While questions remain about the recent clinical trial in France that led to the death of one participant and serious adverse events in others, the study’s design and proposed dosing regimen are among the aspects under scrutiny. You may recall the TGN1412 phase 1 study of 2006, when “after very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening conditions involving multiorgan failure for which they were moved to intensive care unit.” (Click on link for the reference.)

One concern raised in the earlier trial was that the volunteers were all dosed at about the same time, rather than having staggered doses which would have allowed time to watch for reactions before dosing additional subjects. Was this also an issue in the French study? A recent online posting in the journal Nature discusses the possibility, although it also states that more information is needed to draw any conclusions. The Nature article also includes links to the study protocol of the most recent study.