No gender imbalance found in FDA registration trials

Clinical trials of frequently prescribed drugs under consideration for registration by the US Food and Drug Administration show no systemic exclusion of women, according to a journal paper.

Despite several studies reporting under-representation of women in clinical trials, a review of data from the FDA’s registration trials found no evidence of male dominance, according to a study published in the British Journal of Clinical Pharmacology.

The data from 38 drug trials, with a total of 185,479 participants, show that from the clinical development phase, the proportion of women studied increased from 22 per cent in phase 1, to 48 per cent in phase 2 and 3 trials.