PATHWAYS clinical trial paused following new MHRA advice
The MHRA have raised new concerns around the PATHWAYS trial looking into the prescription of puberty blockers among young people with gender incongruence.
The preliminary work in establishing the PATHWAYS clinical trial into the prescription of puberty blockers for children and young people with gender incongruence has been paused, following new concerns raised by the medicines regulator, the MHRA.
Discussions between the MHRA and the trial sponsor, King’s College London, will begin next week to address the new concerns. In the meantime, the trial will not start to recruit until issues raised by MHRA have been resolved between the regulator and the trial clinicians.
A Department of Health and Social Care spokesperson said: “We have always been clear about the red lines regarding this trial – ensuring the safety and wellbeing 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 wellbeing 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 wellbeing of children and young people have always been the driving consideration in every decision we have made regarding this trial and always will be.”
An MHRA spokesperson commented: “With all complex clinical trials, MHRA’s top priority is the safety and wellbeing of the trial participants.
“It is part of the usual process that clinical trials are kept continuously under review and for us to have active scientific dialogue with the trial sponsors.
“The safety and wellbeing of the participants to be recruited into the PATHWAYS clinical trial is paramount, particularly in view of the age of the children and young people who may be involved.
“For this reason, the MHRA is applying the highest scrutiny and taking a cautious and measured approach. We have raised some concerns related to the wellbeing of participants and scientific dialogue will now follow with the trial sponsor.
“We rely on the best scientific evidence to ensure all trials are as safe as possible for those participating.”
The MHRA has written to King’s College London. A copy of the letter is available here Sponsor letter (PDF, 1.23 MB, 4 pages)
