Question to the Department of Health and Social Care:

To ask His Majesty's Government whether the PATHWAYS trial of puberty blockers has commenced; on what date it will be completed; when it is expected that the results will be published; and for what period of time the longer term follow-up of the participants into adulthood will continue.

I refer the Noble Baroness to the answer provided in the House of Commons on 30 October in response to Question 36713, which for ease of reference, is reproduced below, and to the research protocol for the PATHWAYS clinical trial, a copy of which is attached.

As with all clinical trials, the PATHWAYS trial is subject to the reporting requirements set out in the International Council for Harmonisation Good Clinical Practice standards, and to the requirements provided under The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

The research team on the trial is currently working to complete the set-up of the study prior to the start of recruitment. Once under way, the research team will work closely with the advisory boards and other stakeholders to ensure all their findings are accessible and clearly communicated to patients, families, and the general public, alongside dissemination to the scientific community and policy makers.

There is no current plan to publish detailed breakdowns of the trial cohort as suggested by the Hon. Member, in order to protect the safety and anonymity of participants. However, an independent Data Monitoring and Ethics Committee will uphold the safety, rights, and well-being of the study participants and consider the need for any interim analysis.