The FDA expects sponsors of breast cancer trials to include men as well as women and the scarcity of men with the condition is not an acceptable reason for excluding them from a trial, according to a new final guidance from the FDA.

Trials that would exclude men should include the scientific rationale for doing so, the guidance says, adding that it may be possible to extrapolate findings from early-stage studies, literature or both as long as there is no anticipated difference in the treatment’s efficacy and safety due to gender.

For drugs that are expected to behave differently in men and women, sponsors may need to collect additional clinical data from various sources, such as small single-arm trials and trials using real-world data.

The final guidance is virtually unchanged from the draft issued in August 2019 (CenterWatch Weekly, Sept. 2, 2019).

To read the guidance, click here: https://bit.ly/3iDsNai.