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The Pathways clinical trial, designed to evaluate the use of puberty blockers in children experiencing gender dysphoria, has been temporarily halted following a warning from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulator has indicated that the minimum age for participants should be raised to 14, citing concerns over potential long-term biological risks associated with the medication.
Regulatory Concerns Prompt Trial Delay
The MHRA’s intervention has prompted discussions with King’s College London, the trial’s sponsor, to ensure that the safety and welfare of the young participants remain paramount. The Department of Health and Social Care (DHSC) announced that recruitment for the trial will be suspended until these issues are thoroughly addressed.
This clinical trial was initiated in response to the Cass review, which scrutinised the existing research on puberty blockers and found it to be lacking in robustness. Dr Hilary Cass, who spearheaded the review, remarked that the evidence supporting the benefits of such treatments for gender dysphoria in children was “very weak.” She advocated for the trial, recognising the passionate beliefs of clinicians and families regarding the potential advantages of these medications.
The Pathways Trial and Its Objectives
The Pathways trial aimed to recruit approximately 226 young individuals over the next three years. Initially, it was anticipated that participants could be as young as 10 or 11 for biological females and 11 or 12 for biological males. However, with the new guidelines from the MHRA, the minimum age requirement is now expected to be 14, reflecting a cautious approach to the potential risks involved.
In a letter addressed to the trial investigators, the MHRA highlighted the need for a more gradual approach to participant eligibility, stressing that significant and unquantified long-term biological harms could pose risks to younger subjects. The letter suggested that while the trial may eventually consider lowering the age limit, initial recruitment should focus on older adolescents.
Ongoing Commitment to Child Welfare
A spokesperson for King’s College London affirmed that the health and wellbeing of young people experiencing gender incongruence and their families is the institution’s foremost priority. The team is committed to collaborating closely with the MHRA to refine the trial protocol, which has been developed with scientific rigor.
This trial is part of a broader examination of the implications of puberty blockers. In November, it was reported that the NHS had restricted the use of these medications to research settings due to mounting concerns about their safety and effectiveness following recommendations from the Cass review.
Sir Jonathan Montgomery, a professor of health care law at University College London, commented on the situation, emphasising that the discussions surrounding the trial are intended to enhance its protocol rather than halt its progress. He underscored the importance of prioritising participant safety, affirming that this pause reflects the regulatory framework functioning as intended.
Why it Matters
The pause in the Pathways trial underscores the delicate balance between advancing medical research and safeguarding the health of vulnerable populations. As discussions continue between the MHRA and trial sponsors, it is essential to establish a framework that not only addresses safety concerns but also paves the way for informed decision-making regarding treatment options for young people facing gender dysphoria. Ensuring that clinical trials are ethically sound and scientifically robust is critical in navigating this complex landscape, ultimately aiming to foster both understanding and support for affected families.
