MHRA pauses PATHWAYS clinical trial after raising new safety concerns for children and young people in the United Kingdom

Plans for the PATHWAYS clinical trial, which aims to study the prescription of puberty blockers for children and young people experiencing gender incongruence, have been put on hold.

The pause comes after the Medicines and Healthcare products Regulatory Agency (MHRA) flagged new concerns about the study’s safety and methodology.

What the Pause Means

The trial, sponsored by King’s College London, had been in its preliminary stages, preparing to recruit participants.

With the MHRA’s intervention, recruitment will not begin until discussions between the regulator and the trial’s clinical team resolve the highlighted issues.

These discussions are expected to start next week.

A Department of Health and Social Care spokesperson emphasized that the safety and wellbeing of participants have always been the priority.

“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 spokesperson said.

MHRA’s Concerns

While the specifics of the concerns have not been fully disclosed, they reportedly relate directly to the welfare of children and young people involved in the study.

The regulator’s scrutiny is part of an ongoing process to ensure that any clinical intervention is both necessary and safe before being implemented on a wider scale.

Clinicians leading the trial are expected to provide additional evidence and guidance to address these concerns.

Until this process is complete, the trial’s preparations remain paused, highlighting the careful approach regulators are taking when dealing with interventions in young people’s health.

The Future of the Trial

The Department of Health and Social Care confirmed that the trial will only proceed if expert scientific and clinical advice concludes that it is safe and necessary.

The regulator’s involvement ensures that any decisions moving forward will prioritize the wellbeing of participants above all else.

What’s Next?

Next week, detailed discussions between King’s College London and the MHRA will begin to address the regulator’s concerns.

The outcome will determine whether the PATHWAYS trial can safely proceed, be modified, or be postponed indefinitely.

The decision is expected to rely heavily on clinical evidence and expert opinion regarding the risks and benefits of puberty blockers for children and young people experiencing gender incongruence.

Summary

The PATHWAYS clinical trial, focused on puberty blockers for young people with gender incongruence, has been paused due to new safety concerns raised by the MHRA.

King’s College London will work with the regulator to address these issues, with recruitment halted until the trial is deemed safe and necessary.

The wellbeing of participants remains the top priority as clinical and scientific evidence guides the next steps.