Underrepresentation of women in early-stage clinical trials

clinicaltrialsarena.com · 1,869 words · saved by 1 readers

Low female participation in Phase I trials is still persistent today, resulting in continuous sex bias in new drug development. Almost three decades ago, the FDA allowed women back into clinical research to participate as subjects, but the representation of females remains an issue, especially in Phase I trials. A recent study found that low recruitment of women is still a problem in industry-sponsored early-phase trials, with females accounting for 29–34% of participants due to the pharmaceutical industry’s overfocus on childbearing potential and fertility concerns. Inclusion of only one sex in drug development can pose risks to another. If safety profiles are built on males, excluded women are more likely to react negatively to the treatment. In several indications, including cardiovascular disease, research is focused on men and neglects to enroll enough women, explains Dr Maria Brooks, professor of epidemiology and biostatistics at the University of Pittsburgh School of Public Heal

Almost three decades ago, the FDA allowed women back into clinical research to participate as subjects, but the representation of females remains an issue, especially in Phase I trials. A recent study found that low recruitment of women is still a problem in industry-sponsored early-phase trials , with females accounting for 29–34% of participants due to the pharmaceutical industry’s overfocus on childbearing potential and fertility concerns. Inclusion of only one sex in drug development can pose risks to another. If safety profiles are built on males, excluded women are more likely to react n

Underrepresentation of women in early-stage clinical trials

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