Outcome differences by sex in oncology clinical trials

Outcome differences by sex in oncology clinical trials

23 March 2024 | Ashwin V. Kammula, Alejandro A. Schäffer, Padma Sheila Rajagopal, Razelle Kurzrock, Eytan Ruppin
The study by Kammula et al. examines the sex differences in outcomes and toxicity between males and females in oncology clinical trials, highlighting the importance of these differences as mandated by National Institutes of Health (NIH) policies. Using the Trialtrove database, the authors found that only 0.5% of 89,221 oncology clinical trials included curated post-treatment sex comparisons. Among the 288 trials with survival, outcome, or response comparisons, 16% reported statistically significant better outcomes or responses for males, while 42% reported better outcomes or responses for females. The strongest differences were observed in trials of EGFR inhibitors in lung cancer and rituximab in non-Hodgkin’s lymphoma, favoring females. In 44 trials with side effect comparisons, more trials reported lesser side effects in males (22) than in females (13). The study emphasizes the need for more thorough reporting of sex differences in future trials, as current practices often fail to capture these important distinctions. The authors also discuss the limitations of their analysis, including the reliance on Trialtrove data and the challenge of identifying non-significant comparisons in supplementary information. They conclude by calling for improved policies and incentives to encourage more comprehensive sex-specific analyses in clinical trials.The study by Kammula et al. examines the sex differences in outcomes and toxicity between males and females in oncology clinical trials, highlighting the importance of these differences as mandated by National Institutes of Health (NIH) policies. Using the Trialtrove database, the authors found that only 0.5% of 89,221 oncology clinical trials included curated post-treatment sex comparisons. Among the 288 trials with survival, outcome, or response comparisons, 16% reported statistically significant better outcomes or responses for males, while 42% reported better outcomes or responses for females. The strongest differences were observed in trials of EGFR inhibitors in lung cancer and rituximab in non-Hodgkin’s lymphoma, favoring females. In 44 trials with side effect comparisons, more trials reported lesser side effects in males (22) than in females (13). The study emphasizes the need for more thorough reporting of sex differences in future trials, as current practices often fail to capture these important distinctions. The authors also discuss the limitations of their analysis, including the reliance on Trialtrove data and the challenge of identifying non-significant comparisons in supplementary information. They conclude by calling for improved policies and incentives to encourage more comprehensive sex-specific analyses in clinical trials.
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