Overview
- The MHRA confirmed on Friday that it has agreed a modified Pathways protocol that sets minimum entry ages of 11 for birth-registered females and 12 for birth-registered males and requires strengthened participant information.
- King's College London said the patient information has been improved but that there are no major changes to the trial’s design, which still plans to treat participants with puberty blockers for up to two years and monitor outcomes.
- Recruitment remains suspended while legal challenges continue and the MHRA has said no children are expected to be enrolled before August 1 pending the judicial review of regulatory and ethics approvals.
- Regulators and critics have highlighted unresolved safety questions—including possible effects on bone density, fertility and long-term development—and the trial protocol includes closer monitoring and information on fertility preservation.
- The restart has prompted sustained political and public opposition from campaign groups and some clinicians, and the judicial review will determine whether the study can begin recruiting after the current hold.