June 19, 2026

expert reaction to MHRA update on the PATHWAYS clinical trial, that a modified protocol has been agreed by the MHRA as meeting the required regulatory standards, and that the Health Research Authority has approved the trial for its ethical standards

Scientists comment on an update from the Medicines and Healthcare Products Regulatory Agency (MHRA) on the PATHWAYS trial of puberty suppression in gender incongruence. 

Prof Sir Jonathan Montgomery, Professor of Health Care Law, UCL, said:

“It is good that the MHRA and HRA have completed their reviews of the scientific and ethical concerns that have been raised with them about the PATHWAYS clinical trial promptly.  They have ensured that a modified protocol is in place prior to recruitment.  It is encouraging that full regulatory oversight has been possible without unduly delaying the trial.  Legal proceedings are expected to provide further scrutiny.  It is to be hoped that the court will be able to reach a timely conclusion so that the legal status of the trial is confirmed before the anticipated date for commencement on 1 August.  If there are legal issues that the regulators have overlooked, then it is in everyone’s interests that these are clarified as soon as possible.”

https://www.gov.uk/government/news/update-on-the-pathways-clinical-trial

Declared interests

Prof Sir Jonathan Montgomery: “Sir Jonathan Montgomery is Professor of Health Care Law at University College London and a former Chair of the Health Research Authority.  He has been providing advice to the study team on how to ensure compliance with legal and ethical requirements on an unremunerated basis and is not one of the investigators in receipt of the grant.”