Clinical Trials

Elsevier, Studies in History and Philosophy of Science, Volume 91, February 2022
Double standards are widespread throughout biomedicine, especially in research on reproductive health. One of the clearest cases of double standards involves the feminine gendering of reproductive responsibility for contraception and the continued lack of highly effective, reversible methods for cisgender men. While the biomedical establishment accepts diversity and inclusion as important social values for clinical trials, their continued use of inequitable standards undermines their ability to challenge unfair social hierarchies by developing male contraception.
Introduction: Women continue to be underrepresented in oncology clinical trials, leading to poor, underpowered subgroup analyses that cannot be generalized to cancer patients in practice. In 2014, the US Food and Drug Administration (FDA) released an Action Plan, which included actions to improve the quality and reporting of demographic subgroup data. We sought to evaluate the five-year progress since the release of this report by assessing the credibility of sex-specific subgroup analyses in oncology clinical trials.