Wednesday, September 06, 2006

Risks to healthy volunteers in research studies

Jeffrey Drazen in today's New England Journal of Medicine provides editorial commentary on risks to healthy volunteers in clinical research, prompted by a study also published in today's NEJM (subscription to the journal required to read the full study).

Drazen notes, "Clinical research can be a risky endeavor. In this issue of the Journal, Suntharalingam et al. describe the events that occurred when six healthy volunteers received a dose (0.1 mg per kilogram of body weight) of TGN1412...In all six patients, the cytokine-release syndrome developed, including multiorgan failure. Two of the patients required mechanical ventilation, and all received renal-replacement therapy. All six had severe hypotension, and peripheral ischemia developed in one patient to the extent that surgical treatment was required."

Drazen concludes, "As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimize risk, but the future health of the world population demands that we not let adverse events put an end to medical progress. We must treat those at risk with respect and great care, but the work must go on. The troubling fact of the matter is that without people who are willing to place themselves at risk to advance our knowledge, we will be frozen in our current state of understanding. And this state simply may not be good enough to enable us to meet the next unexpected challenge that comes our way."

Further commentary on the rationale for attempting the therapy and why it may have gone wrong in these healthy volunteers is included in a perspective piece by Sharpe and Abbas.

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