Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of completing the Data Linkage Study to help inform safe PATHWAYS trial design.

Children’s healthcare must always be evidence-led. That’s why we are following expert, independent advice from the Cass Review to implement a programme of research to support the National Health Service to provide the best support to children and young people with gender incongruence.

The programme includes a data linkage study which will provide valuable information about the needs, experiences, and outcomes of former Gender Identity Development Service patients. However, the study will not provide high-quality or ‘causal’ data about the relative benefits and harms of puberty supressing hormones, when administered to current National Health Service patients alongside an improved model of care. Only a high-quality prospective clinical trial can provide that data.

Therefore, the Government has commissioned the PATHWAYS study, which will provide new evidence directly relevant to the current cohort of children and young people accessing newly designed NHS gender services which reflect the Holistic Assessment Framework proposed by the Cass Review. The study includes the PATHWAYS trial, which is 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 National Institute for Health and Care Research website at the following link:

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

It includes details on eligibility criteria, control group design, and follow up. It includes details of HORIZON INTENSIVE, which will provide a non-randomised control group of young people with gender incongruence not receiving puberty-suppressing hormones.

The trial has been subject to independent scientific, ethical, and regulatory scrutiny and peer review and has received the necessary research approvals. The study design, including inclusion criteria and safety protocols, has been thoroughly scrutinised to protect young people's wellbeing. Acceptance into the trial is subject to robust procedures including consent from a parent/carer and informed assent from the young person, a diagnosis of gender incongruence for at least two years, receipt of tailored psychosocial support, and the puberty suppression being deemed clinically appropriate, within the context of a study, by both their NHS care team and the national multi-disciplinary team. The research sponsor is responsible for organising insurance for the trial.

After the first two years, all participants will be included in annual follow-up throughout the study period. Follow-up into adult life is important and participants will also be asked to consent to long-term follow-up through ongoing involvement with the PATHWAYS team, with a national health registry for gender care and linkage to health information routinely collected by NHS Digital.