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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. 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 Health.
Find out more. The lack of sex equity in clinical research boils down to the financial and legal risks associated with a participant becoming pregnant. Also, recruiting female subjects might seem to create additional layers of cost and burden to sponsors as they are more likely to have adverse reactions to the investigational drug and age-related biological differences create additional subpopulations.
But are sponsors being penny-wise and pound-foolish by prioritising the recruitment of males in early-stage clinical trials? Clinical Trials Arena spoke to experts on the importance of including females in the early stages of drug development and what can be done to ensure equal representation of both sexes. Although clinical research has made immense strides in sex equity, there is still some way to go.
It entailed the need for providing a strong justification to only include one sex in an NIH-funded study. Even though the policy was issued seven years ago, there is a lag period, says Dr Marcia Stefanick, professor of obstetrics and gynecology at Stanford University School of Medicine.
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