There are conflicting reports on the representation of women in clinical trials, with one group saying they are overrepresented and others disagreeing. What is really going on?
The Institute of Medicine advises that sex matters, so both males and females need to be represented in trials to detect gender differences in the effects of pharmaceutical and nonpharmaceutical interventions. Women’s healthcare will be compromised due to a lack of sex-specific information about drugs, their doses and unusual uses of drugs.
The demographic make-up of clinical trial participants was examined by several groups of scientists to access whether efficacy and safety data were obtained for both women and men for new drugs approved during the period from 2013 to 2015. They concluded that there was no evidence of any systematic underrepresentation of women in clinical trials.
Recruitment and the retention of women in clinical trials are more expensive and complex than that of men. Men are more likely to have medical insurance through their workplace, veteran‘s services and unions and make themselves more readily available. Women, on the other hand, have child care, dependency from elders, lack of transport, lack of healthcare, and lack of time due to demands from work and family commitments. Female participants also have pregnancy concerns, with a lack of knowledge of what the effects of any drug study would have on a foetus. Precautions will need to be adhered to while taking part in a study to eliminate the possibility of becoming pregnant.
Several studies have reported clinical trials having a lack of gender diversity, with female participation increasing during the clinical development phases. There are larger numbers of women in Phase 2/3 than in the Phase 1 studies, such as Adaptive Phase 1 Clinical Studies RichmondPharmacology. A further study by the US Food and Drug Administration has concluded that based on the estimated ratio of people affected by a particular disease, there were appropriate levels of female participation; however, in most drug development programmes, racial minorities were under-represented. It is very important as we go forward to remain vigilant about the potential of disparities and address the under-representation of some racial minorities, especially as some of these groups have a high prevalence for a particular drug indication.
The general consensus is that there is no shortfall in women participating in clinical trials.