It’s time for clinical researchers to work with the U.S. Food and Drug Administration (FDA) to address the bias inherent in the current definitions used to inform adverse event (AE) reporting, argues Robert Jeanfreau, MD, CPI, owner/medical director at MedPharmics, LLC.
“At the outset, the term ‘adverse event’ in and of itself bespeaks a certain prejudice,” Jeanfreau writes in the February 2017 issue of Clinical Researcher. “An unintended and unrecognized effect of using the term is the introduction of a subtle source of error.”
What’s needed, Jeanfreau argues, is a look at the issue from a new perspective. “When we start out by labeling an event ‘adverse,’ you’ve already entered in some element of bias,” he says. In some cases, the more apt term might be “health event,” he suggests, because the occurrence might be a positive deviation, thus not an adverse event in the literal sense of the term.
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Speaking with ACRP, Jeanfreau offered examples of situations where flawed adverse event definitions could hamper trial efficacy:
- Looking at a diabetes drug that has an unrecognized effect of causing weight loss; it may have been administered both to someone who is overweight and to someone who is underweight. The latter may see the weight loss as an adverse event while the former may see it as a positive event. “If you take the stance that this is a change in health and don’t have a colored view [that automatically labels it ‘adverse’], then both phenomena would have been captured,” Jeanfreau says.
- Consider a situation where a drug causes a slight increase in hematocrit [packed blood cell volume, or the volume of red blood cells in blood] in an anemic patient; the investigator may not even identify that as an adverse event, as opposed to one that causes a decrease in the hematocrit level. That second situation could be reported as an adverse event. “When you start out by saying you are looking for adverse events, you could be overlooking aspects of how the drug works,” Jeanfreau notes.
Any change in how adverse events are officially defined would require input from the FDA, Jeanfreau says, adding, “It’s a significant [proposed] change.”
For more information, see Jeanfreau’s Clinical Researcher article, Is Bias Inherited in the Current Reporting Practices for Adverse Events?
Author: Michael Causey