From Inclusion to Impact: Closing the Female Data Gap in Clinical Trials

Author(s): Lisa Campbell & William Hind

From Intention to Execution

Across this series, we have explored how the female data deficit became embedded within drug development, why regulatory progress has not consistently translated into practice, and how behavioral and organizational dynamics continue to reinforce existing patterns. (See previous articles published in March, April, and June/July 2026.)

The industry is no longer lacking awareness of the problem. Guidance exists across regulators, expectations around inclusion have evolved, and the consequences of incomplete evidence are increasingly understood. The challenge looking forward is operationalizing inclusion consistently and measurably across drug development.

We also need greater focus on common women’s health conditions such as menopause, endometriosis, and polyendocrine metabolic ovarian syndrome (PMOS) to ensure that we truly understand them, that they have been studied through appropriately designed clinical studies (real-world evidence generation and clinical drug trials), and that the endpoints of these studies are meaningful and accepted by regulators. In women’s health, the problem is no longer whether we are running enough trials; it is whether those trials are capable of answering the questions that matter to women and their caregivers.