The Medicines and Healthcare products Regulatory Agency has raised new concerns regarding the planned PATHWAYS clinical trial, which aims to research the prescription of puberty blockers for children and young people experiencing gender incongruence.
As a result, preliminary work to establish the trial has been paused, and the study will not begin recruiting participants until the issues identified by the regulator are resolved.
The PATHWAYS trial is sponsored by King’s College London and was designed to explore the clinical use of puberty blockers in young people. Following the regulator’s latest review, the MHRA has requested further consideration of specific concerns before the study can progress.
Formal discussions between the MHRA and the trial sponsor will begin next week, with the aim of addressing the issues raised and ensuring the trial meets all necessary safety, regulatory and ethical standards.
Until these matters are resolved, no recruitment or further trial activity will take place.
A spokesperson for the Department of Health and Social Care said:
“We have always been clear about the red lines regarding this trial – ensuring the safety and well-being of the children and young people involved and always being led by the clinical evidence.
“The MHRA has now raised new concerns – directly related to the well-being of children and young people – and scientific dialogue will now follow with the trial sponsor.
“As the evidence is now being interrogated by clinicians, preparations for the trial have been paused while the MHRA and clinical leaders work through these concerns.
“This trial will only be allowed to go ahead if the expert scientific and clinical evidence and advice conclude it is both safe and necessary.
“The safety and well-being of children and young people have always been the driving consideration in every decision we have made regarding this trial and always will be.”
King’s College London and the trial clinicians will work directly with the MHRA to clarify, review and address the issues identified. Only once the regulator is satisfied will the PATHWAYS trial be permitted to move forward.
The pause ensures that all regulatory and safety requirements are upheld before any young people are invited to participate in the study.
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