Minorities Need to Be Included in Clinical Trials

A 39-year old patient of mine was watching the New England Patriots game when he noticed blood on his shirt coming from his left nipple. Another 42-year old patient found a lump in his breast and changes in his nipple that didn’t go away. Men get breast cancer too, and they’re spreading the word. Male Breast Cancer awareness is taking off, with celebrities like Samuel Jackson and Mark Ruffalo tweeting pictures of their nipples last week to raise awareness as part of the #InTheNipOfTime campaign, and 24 states in the union officially designating the third week in October to be “Male Breast Cancer Awareness Week“. But awareness is not enough.

Most breast cancer treatments are based on clinical trials done primarily in women, who comprise 99% of the breast cancer population; the results are then extrapolated to men. But is this appropriate? Just as we now realize that heart disease may be a different phenomenon in women as it is in men and lament the fact that few women participated in the trials that defined management of cardiac conditions, we tend to treat conditions based on data derived from patients who participate in clinical trials, often to the detriment of minorities who either were not afforded the opportunity or chose not to participate.

Part of the blame for this rests with those of us who are clinical investigators. How many studies are focused solely on male breast cancer? Or even worse, how many trials of breast cancer treatments exclude men altogether? Of the 1839 currently open clinical trials on breast cancer listed on clinicaltrials.gov, only 742 have male participants, and only two studies focus specifically on male breast cancer. I can appreciate that it is difficult to do —> Read More