An important goal of early-phase clinical trials is to discover a drug’s possible side effects.
An important goal of early-phase clinical trials is to discover a drug’s possible side effects. But despite FDA guidelines seeking to standardize this reporting, a University of Colorado Cancer Center study finds significant variation in how drug side effects are reported, potentially making some drugs seem safer or less safe than they really are.
“Without standardizing how we present such data, there is the potential for misinformation about these side effects,” says Emily Simons, MD, MPH, senior resident at University of Colorado School of Medicine and the first author of the study.
The group including senior author D. Ross Camidge, MD, PhD, got interested in the topic after seeing how differently the side effects of new drugs for treating lung cancer were being presented – and realizing that differences in reporting methods could over- or under-estimate the apparent safety of such drugs.
“Sometimes you only report an adverse event that happens in, say, 10 percent or more of patients on a trial. However, if you split related side-effects into lots of little sub-groups, perhaps no one event reaches this 10 percent threshold and nothing gets reported,” Simons says. “In contrast, if you combine rationally grouped events – like confusion and memory issues – then this group passes 10 percent and you could clearly see the side effects as, for example, very broadly affecting higher functions of the brain.”
Read more at University of Colorado Anschutz Medical Campus
Image: Emily Simons, MD, MHP and colleagues show that variations in how side effects are reported in early-phase clinical trials can make drugs seem safer or less safe. (Credit: University of Colorado Cancer Center)
