February 20, 2026

expert reaction to MHRA statement and letter, and DHSC announcing a pause of the PATHWAYS clinical trial of puberty suppression in children and young people with gender incongruence

The MHRA released a statement about the Pathways trial of puberty suppression in children and young people with gender incongruence, and they published a letter they had sent to the KCL triallists.  DHSC released a statement announcing a pause to the trial.

An HRA (Health Research Authority) spokesperson, said:

“The Department of Health and Social Care has announced that the PATHWAYS TRIAL of puberty supressing hormones has been paused.

“PATHWAYS TRIAL is a Clinical Trial of an Investigational Medicine Product (CTIMP) and was approved via combined review from the HRA and a Research Ethics Committee entirely independent of the research team, sponsor and funder; as well as the Medicine and Healthcare products Regulatory Agency (MHRA) as medicines regulator.

“The REC reviews its ethics opinion if new information is received about a trial which might have changed its original decision.  This includes anything which leads to amendments to the trial design and which might be submitted to or required by MHRA.  MHRA has also shared information about its active scientific dialogue with the trial sponsors.  Amendments, or changes to a study, must be reviewed and approved by the REC to ensure that the study still has ethics approval.

“As the PATHWAYS study has been paused, we will review the study again, in line with our standard operating procedures, before it can restart.  We continue to work closely with MHRA to manage and respond to concerns raised about the trial.”

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

“If the MHRA has concerns over safety, it is entirely proper that they are explored.  The letter to the investigators is clear that the discussions are intended to strengthen the protocol not to stop the trial.  The letter also states that these are scientific issues and not a result of legal action.  The focus here is on safety, as it should be.  This pause shows the regulatory process working properly and in the interests of participants.”

* MHRA statement: https://www.gov.uk/government/news/mhra-statement-on-the-pathways-puberty-blocker-trial

MHRA letter to KCL: https://assets.publishing.service.gov.uk/media/6998b06d047739fe61889efb/Sponsor-letter110226.pdf

DH statement: https://www.gov.uk/government/news/pathways-clinical-trial-paused-following-new-mhra-advice

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.”

For all other experts, no reply to our request for DOIs was received.