Published on 27 February 2026, the Medicines and Healthcare products Regulatory Agency reiterated that participant safety and wellbeing remain the priority for the Pathways clinical trial. The regulator said complex trials are kept under continuous review and that scientific dialogue with sponsors is active and ongoing. (gov.uk)
The agency added that its multidisciplinary experts will continue to meet King’s College London to agree next steps, and confirmed that Professor Jacob George has been recused from further involvement in the Pathways trial as a precaution following the identification of social media posts made before his appointment. (gov.uk)
This update sits alongside the Department of Health and Social Care notice of 20 February 2026 confirming that preliminary work to establish the Pathways trial has been paused while new wellbeing concerns raised by the regulator are addressed. Recruitment will not begin until those issues are resolved through discussions between the MHRA and King’s College London, the trial sponsor. (gov.uk)
King’s College London describes Pathways as a randomised controlled study assessing the effects of puberty‑suppressing hormones in young people with gender incongruence. The project is led by King’s College London, co‑sponsored with South London and Maudsley NHS Foundation Trust, funded through the National Research Collaboration Programme with NIHR, and overseen by independent data and steering committees. (kcl.ac.uk)
The regulatory framework is also changing. The Health Research Authority confirms that the updated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 take effect on 28 April 2026, aligning MHRA and Research Ethics Committee reviews, strengthening transparency requirements, and replacing the term ‘amendment’ with ‘modification’. (hra.nhs.uk)
Policy on access to puberty‑suppressing hormones has tightened over the past two years. Following the Cass Review, the government moved to an indefinite ban on private prescriptions for under‑18s in December 2024, while NHS England had already stopped routine prescribing outside research earlier in 2024. (gov.uk)
For sponsors and investigators, the MHRA’s statement signals that iterative, evidence‑based engagement with the regulator is expected for complex designs, and that impartiality safeguards can include precautionary recusals where potential conflicts are identified in publicly available material. Governance documentation and safety‑critical protocol elements will attract close scrutiny.
For prospective participants and families, the pause means no enrolment while regulatory discussions proceed. Care remains within NHS services, and any resumption will be communicated once the MHRA and the sponsor set out agreed next steps. (gov.uk)
Policy and research teams should monitor GOV.UK and King’s College London for any protocol modifications, eligibility updates or additional oversight measures agreed with the regulator, particularly as the new CTIMP rules come into force on 28 April 2026. (hra.nhs.uk)