Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what role NHS England played in determining the eligibility criteria for children recruited into the PATHWAYS trial.

The Government is committed to supporting research that delivers a robust, evidence-based understanding of the needs, and support and treatment options for children and young people living with gender dysphoria. A partnership between NHS England and the National Institute for Health and Care Research (NIHR) is working to fund and deliver independent research that fulfils that aim.

One element of this is the PATHWAYS trial, a carefully designed clinical trial to assess the relative benefits and harms of puberty-suppressing hormones as a treatment option for children and young people with gender incongruence. The trial protocol is publicly available on the NIHR website, at the following link:

https://fundingawards.nihr.ac.uk/award/NIHR167530.

This positively responds to the Cass Review’s recommendation that a clinical trial, alongside a broader programme of research, was necessary to gather the evidence required into the most effective way to care for this group of children and young people.

The trial was designed and will be delivered by an independent research team. This was in conjunction with patient and public involvement as well as independent clinical and legal experts, including those who specialise on medical ethics. This team is responsible for the protocol design, including eligibility criteria, consent, and outcomes.

The proposal has been through all the usual review and approval stages ahead of set up and opening to recruitment. These include independent academic peer review, NIHR funding committee consideration, and a full regulatory review, including a focus on ethics. It has obtained approval from the regulatory authorities, including the Health Research Authority Ethics Committee and the Medicines and Healthcare products Regulatory Agency.