More—and Better—Information Needed
Although women have some conditions at much higher rates than men, and experience more adverse effects than men, and may need smaller dosages than men, they are frequently lumped in the same category as men. An article discussed on the site The Hill points out that “Despite the inclusion of women and diverse races in the trials, adverse events and safety issues were not reported by demographic subgroups.”
The article calls upon the FDA to “require manufacturers to not just collect demographic data (sex, age, race and ethnicity) in clinical trials but to actually determine the effect of the treatment for the different subgroups and report such information, first by sex and then followed by age and then race/ethnicity to get a full understanding of subgroup-specific treatment effects.”
Read the article.
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