“Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials” MHRA consultation

[ItisntOver]

So, it is good to see the topic of greater consideration of women in trial design is being addressed. But it seems like regulators aren’t about to adopt plain language communication any time soon. And they’ve not made it straightforward to comment or contribute. To be fair, the same is true for the EMA (European Medicines Agency).

Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials

Closes 5th September.

https://www.gov.uk/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-e21-guideline-on-the-inclusion-of-pregnant-and-breast-feeding-individuals-in-clinica

The erasure of women from our own healthcare is something that I will never forgive. It’s always women who are pushed aside for the language of gender ideology - every single time. If men can have clarity, why can’t we?

www.gov.uk/government/news/biggest-prostate-cancer-screening-trial-in-decades-to-start-in-uk

Responded, thank you. So disappointing to see the difference in language (pregnant and breast-feeding people vs men need prostrate cancer screening etc etc etc) 😡

As a continuation of this topic, there’s a Linked In thread that has a contribution from the excellent Susan Bewley. The OP
https://www.linkedin.com/posts/shaun-treweek-49854434_do-pregnant-people-have-opportunities-to-activity-7347914739915653121-6rxA?
in the thread linked to this paper: Do pregnant people have opportunities to participate in clinical trials? an exploratory survey of NIHR HTA-funded trialists

Burrow R, Hinton L, Clarke M. Do pregnant people have opportunities to participate in clinical trials? an exploratory survey of NIHR HTA-funded trialists. Trials. 2025 Dec;26(1):1-0.

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08949-w

Susan Bewley’s response: please feedback about this article which aims to help precision. There is no such thing as 'pregnant people' as the adjectival form can never be applied to the 49% of male persons, only the 51% of female persons. Losing clarity risks muddled thinking, denominators and good science: https://www.frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2022.818856/full. There is a debate to be had about the precision and intelligibility of terminology of language that is inclusive (i.e. one that recognises two, overlapping, sometimes conflicting but important definitions of sex and gender identity) rather than erasing the entire body of literature discussing sexism in medical research and the exclusion of adult females ('women' using the definition of a sex class, OR more clumsily if you wish to use identity definition 'cis-women, trans men, nonbinary and all other AFAB people') to their harm - as they are the only persons may be or have been pregnant.

On the LinkedIn thread linked above, I was heartened to see that Nick Ross (of BBC Crimewatch fame) has also waded in with a rebuke against the term “pregnant people”. I’ve pasted his comment below:

Pregnant people? Where are the pregnant men, Shaun? Should I as an XY male be worried about periods? Or should I be more worried that good scientists are being cowed into writing women out of womanhood and even motherhood