MHRA raises concerns on PATHWAYS puberty blocker trial

Many of you will have seen headlines about the PATHWAYS puberty blocker trial this week. Here’s what changed on 20 February 2026: the UK medicines regulator (MHRA) said it has raised concerns about the wellbeing of children who might join the study and is applying the highest level of scrutiny, as it does with complex trials. (gov.uk)

Because this is a medicines trial, the MHRA keeps protocols under continuous review and speaks directly with sponsors when issues arise. The agency has written to King’s College London, which sponsors PATHWAYS, to outline its concerns and next steps, and has released the letter so the public can see the questions being asked. (gov.uk)

What does the letter ask for? Proposed changes include a minimum age of 14 at the time of consent, clearer ‘exit plans’ for anyone leaving the trial, and tighter safety monitoring with defined stop rules if harms appear-for example around bone health checks or signs that need urgent review. These are the kinds of safeguards regulators seek in studies involving children. (assets.publishing.service.gov.uk)

What’s the immediate impact for families and teachers supporting young people? The Department of Health and Social Care says preparations for PATHWAYS are paused and recruitment will not begin while the MHRA and King’s hold scientific talks next week. The trial can only proceed if evidence and advice conclude it is safe and necessary. (gov.uk)

So what is PATHWAYS meant to study if and when it opens? King’s College London describes a randomised design: some young people would start puberty blockers straight away, while others would start after 12 months, with linked studies tracking health, learning and day‑to‑day wellbeing over time under independent oversight. (kcl.ac.uk)

Who checks the ethics and safety beyond the sponsor? The Health Research Authority says an independent Research Ethics Committee approved the study and will review any substantial amendments; because preparations are on hold, it will look again before a restart, in line with its standard procedures. (hra.nhs.uk)

Here’s the wider policy picture we should all understand. NHS England’s policy from 12 March 2024 states that puberty‑suppressing hormones are not routinely commissioned for under‑18s, and in December 2024 the government made an order that indefinitely restricts private or overseas routes for this use, with a review due in 2027. Clinical trials are the evidence‑building route. (england.nhs.uk)

Media‑literacy check as you read new coverage: ‘paused’ is not ‘cancelled’. The regulator has asked for stronger safeguards; the sponsor can propose amendments; and independent committees will scrutinise any changes before a single participant is enrolled. Until then, follow updates from the MHRA, DHSC, King’s and the HRA rather than rumour. (gov.uk)