Identifying sex differences in outcomes and toxicity between males and females in oncology
clinical trials is important and has also been mandated by National Institutes of Health
policies. Here we analyze the Trialtrove database, finding that, strikingly, only 472/89,221
oncology clinical trials (0.5%) had curated post-treatment sex comparisons. Among 288
trials with comparisons of survival, outcome, or response, 16% report males having
statistically significant better survival outcome or response, while 42% reported significantly …

e18808 Background: NIH guidance advises clinical trials to analyze participants by sex to
improve inclusivity. We performed a systematic analysis of reported differences in outcomes
between males and females in a registry of oncology clinical trials to characterize treatment
response differences more broadly by sex for future trials. Methods: We analyzed Trialtrove
(https://citeline. informa. com/trials/results), a trial repository using over 58,000 sources, to
search for oncology trials that compared outcomes in male and female participants. We …