Low representation in clinical trials ‘tied to real-world harms’

The issue translates into poorer survival for some women with early breast cancer, researchers say
Reuters Health
doctors recording information on clipboard and tablet

Women with early breast cancer who are not represented at all in clinical trials of therapies are nearly three times more likely to die over five years than others who fall into groups well-represented in such trials, a study shows. 

And among patients who are represented, but poorly, in clinical trials — such as women who are not white, or aged 70 and over — the mortality risk for those with the hormone-receptor-positive/human epidermal growth factor receptor 2-negative (HER2-negative) subtype, is 38% higher than for patients well-represented in trials, the researchers say.

In a presentation to the American Society of Clinical Oncology (ASCO) Quality Care Symposium, Dr Jeffrey Franks (PhD) of the University of Alabama at Birmingham, US said various categories of patient were under-represented or excluded from clinical trials.

Of the 240,000 women diagnosed with early-stage breast cancer each year in the US, 24% were of non-white ethnicity, 44% were at age extremes, especially over the age of 70; and 32% had comorbidities, he said.