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PATHWAYS Puberty Blockers Trial Paused After Regulator Raises Concerns

lite News Desk 2 min read

At a glance

  • The PATHWAYS clinical trial into puberty blockers has been paused
  • The MHRA recommended raising the minimum participant age to 14
  • Recruitment will not begin until concerns are addressed

The Department of Health and Social Care published that the PATHWAYS clinical trial, which was set to study the use of puberty blockers in young people, has been paused following new concerns raised by the Medicines and Healthcare products Regulatory Agency (MHRA.

The MHRA stated that its concerns relate to the wellbeing of children and young people involved in the trial. The agency recommended that the minimum age for participants should be increased to 14 years, which is higher than the original lower age limit planned for the study.

According to the Department of Health and Social Care, discussions between the MHRA and the trial sponsor, King’s College London, are scheduled to start next week. The department confirmed that recruitment for the trial will not proceed until the identified issues have been resolved.

The PATHWAYS trial was originally designed to include around 226 participants, with eligibility for biological females starting at ages 10 to 11 and for biological males at ages 11 to 12. The upper age limit for participants was set just under 16 years.

What the numbers show

  • The trial aimed to recruit about 226 young people
  • Initial age eligibility ranged from 10 to nearly 16 years
  • The MHRA recommended raising the minimum age to 14 years

The trial was commissioned after the Cass Review, which found that there was a very weak evidence base for the benefits of puberty blockers in children. The review recommended conducting a clinical trial to gather more data on the subject.

The Department of Health and Social Care stated that the recruitment process will remain on hold while the MHRA and King’s College London address the concerns raised. No new participants will be enrolled until the discussions are complete and any necessary changes are made to the trial protocol.

Campaigners, including author J.K. Rowling, described the trial as “an unethical experiment on children who can’t give meaningful consent,” according to statements published by the Press Association via Yahoo News UK.

The outcome of the discussions between the MHRA and King’s College London will determine when and if the PATHWAYS trial can resume recruitment under revised conditions.

* This article is based on publicly available information at the time of writing.

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