Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether all arms of the Pathways clinical trials have been paused.

The PATHWAYS TRIAL focuses on the effects of puberty suppressing hormones on young people’s physical, social, and emotional well-being specifically when offered alongside the new model of National Health Service gender care based on comprehensive assessment and tailored psychosocial support. Therefore, the PATHWAYS study includes three non-interventional research projects:

• PATHWAYS Voices involves speaking to young people, parents and staff about their experiences of living with gender incongruence and their care in NHS Gender Services;
• PATHWAYS Horizon tracks the physical, social and emotional wellbeing of all young people attending United Kingdom NHS Gender Services who want to take part in the Horizon study, along with their parents; and
• PATHWAYS Connect studies whether puberty suppressing hormones affect young people's thinking and brain development through cognitive tests and brain scans. It would include all young people in the PATHWAYS trial but also some of the young people from the Horizon study.

As announced on 20 February, the PATHWAYS clinical trial has been paused, following new queries raised by the medicines regulator, the Medicines and Healthcare products Regulatory Agency. While it is paused, recruitment of children and young people into the trial will not start, and therefore no children or young people will receive puberty suppression. As the intensive element of PATHWAYS Horizon is designed to provide a matched control group for the trial, and as PATHWAYS Connect is designed to compare children and young people receiving puberty suppression with a group in the intensive element of PATHWAYS Horizon, it is not possible for these aspects to progress without the trial element. The other PATHWAYS study projects are not affected by this pause.