For more than thirty years, a paradox has persisted in medical research: treatments target the entire population, but are still primarily based on data collected from men. However, European and North American health authorities are asking to integrate sex and gender into protocols. On the ground, the place of women
in the clinical trials remains very incomplete, as Clotilde Coron and Sandra Charreire Petit of Paris Saclay University point out in an article in The Conversation.
An analysis of more than 52,000 tests recorded on
ClinicalTrials.gov since the 1990s clearly shows an increase in female inclusion over time. The researchers behind this work, however, observe that this progression stems mainly from compliance with new recruitment rules, and much less from real consideration of the specificities of women’s health.
Women and clinical trials: when the results remain blind
This blind spot is rooted in a strong medical androcentrism : the male body serves as a model, the female body as a variant. Even “neutral” diagrams in textbooks often depict male silhouettes. A study published in European Heart Journal showed that the risk of incorrect diagnosis ofmyocardial infarction is 40% higher for women, with an average delay of 53 hours before treatment in Switzerland, compared to 15 hours for men.
Medications follow the same logic. Studies highlight that women do not always metabolize molecules like men, which can modify the effectiveness or increase the
side effects. However, very few trials publish separate results according to sex, for both benefits and risks. Without gender analysis, future treatment recommendations remain blind to the specific needs of female patients.
Phase 1 of clinical trials: a weak link for women
The early phase of testing, known as phase 1however, plays a key role: it tests the toxicity of a candidate drug and sets the recommended dose and frequency of administration. The study based on more than 52,000 protocols shows that women remain less present than in the other phases. When we define the reference dosage, their biology therefore weighs less in the balance.
Seen from a distance, the overall proportion of participants may seem correct. This average rate is, however, artificially inflated by numerous trials devoted to diseases almost exclusively female, such as certain breast cancers. In mixed pathologies, the actual proportion of women remains lower, which is also noted by institutions such as the High Council for Equality in its work on health.
Towards therapeutic innovations truly designed for women
Public authorities now encourage the integration of gender from the ideation of therapeutic innovations and in concept testing. In Europe as in North America, the texts require that the protocols provide for a balanced presence of women and men. Organizations such as Health Canada also recommend a systematic analysis of data according to sex, so that the results can truly guide differentiated care.
For these experts, providing from the start a real analysis by sex of the test data remains the decisive lever.