The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a letter to the sponsor of a trial involving puberty blockers for children, raising concerns that ultimately resulted in the study being paused.
According to a previous report from The Telegraph earlier this week, children were set to be paid to participate in the controversial trial. The regulator also indicated it wanted to discuss introducing a minimum age of 14 for participants. The outlet has now reported that discussions between the MHRA and the trial sponsor, King’s College London, a public research university, will take place next week to address the concerns.
A spokesman for the Department of Health and Social Care said the medical regulator was concerned about the “well-being of children and young people.” The trial was expected to include roughly 226 children who identify as transgender and was designed to study the side effects of puberty blockers. It had been scheduled to begin in April.
Puberty blocker drugs have been indefinitely banned by the UK Health Secretary after the Commission on Human Medicines determined they pose an “unacceptable safety risk” to minors.
Preparations for the trials have now been “paused” according to a Department of Health and Social Care spokesman.
“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 spokesman said. “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,” the spokesman added. “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.”
According to a previous report from The Telegraph earlier this week, children were set to be paid to participate in the controversial trial. The regulator also indicated it wanted to discuss introducing a minimum age of 14 for participants. The outlet has now reported that discussions between the MHRA and the trial sponsor, King’s College London, a public research university, will take place next week to address the concerns.
A spokesman for the Department of Health and Social Care said the medical regulator was concerned about the “well-being of children and young people.” The trial was expected to include roughly 226 children who identify as transgender and was designed to study the side effects of puberty blockers. It had been scheduled to begin in April.
Puberty blocker drugs have been indefinitely banned by the UK Health Secretary after the Commission on Human Medicines determined they pose an “unacceptable safety risk” to minors.
Preparations for the trials have now been “paused” according to a Department of Health and Social Care spokesman.
“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 spokesman said. “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,” the spokesman added. “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.”
