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The Pathways clinical trial, aimed at assessing the use of puberty blockers for children experiencing gender dysphoria, has been temporarily halted following a directive from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory body has raised significant concerns regarding the safety of participants under the age of 14, citing the potential for unquantified long-term biological risks associated with the treatment.
Safety Concerns Prompt Regulatory Action
The MHRA has mandated that the trial, which was initially designed to include participants as young as 10 for biological females and 11 for biological males, must now revise its eligibility criteria. Discussions between the MHRA and King’s College London, the trial’s sponsor, are scheduled to commence next week to address these urgent wellbeing issues.
The Department of Health and Social Care (DHSC) confirmed the pause, stating that recruitment will not resume until all concerns are adequately addressed. This decision underscores a growing emphasis on safeguarding the health of minors in clinical research settings, particularly in areas as sensitive as gender-affirming treatments.
Background of the Pathways Trial
The Pathways clinical trial was initiated in response to findings from the Cass review, which examined the existing evidence surrounding gender care for children. Dr Hilary Cass, who conducted the review, highlighted the lack of robust scientific backing for the benefits of puberty blockers. Despite acknowledging the passionate beliefs of clinicians, children, and families regarding the treatment’s efficacy, she deemed a comprehensive clinical trial necessary to establish a sound evidence base.
The review, published in 2024, had previously recommended a ban on the routine use of puberty blockers for children, with their application limited to research environments. Following this recommendation, NHS England announced that the administration of puberty blockers would no longer be standard practice for children with gender dysphoria.
Regulatory Discussion and Future Implications
In a letter to the trial’s investigators, the MHRA expressed its position on age limits, suggesting that the minimum eligibility should be adjusted to 14 years. The agency emphasised the need for a “graded/stepwise” approach to participant selection, based on the outcomes of the trial. This precautionary measure aims to ensure that the safety of younger participants is prioritised while still allowing for future research opportunities.
Sir Jonathan Montgomery, a professor of health care law at University College London, noted that the discussions initiated by the MHRA are intended to enhance the trial’s protocol rather than halt it entirely. He affirmed that the focus remains on the safety of participants, which is paramount in clinical trials involving vulnerable populations.
Ongoing Commitment to Rigorous Standards
A spokesperson for King’s College London reiterated the institution’s commitment to the wellbeing of young people undergoing gender transition, stating that the trial has been developed with scientific rigor at its core. The university will continue to collaborate with the MHRA to facilitate a thorough review of the trial’s parameters.
The trial was set to recruit approximately 226 participants over a three-year period, and although the youngest candidates were expected to be 10 or 11, the research team had anticipated that a stringent selection process would likely result in older participants.
Why it Matters
The pause in the Pathways clinical trial highlights the delicate balance between advancing medical research and ensuring the safety of young individuals. As discussions around gender identity and treatment options evolve, it is imperative that clinical protocols safeguard the health and wellbeing of minors. This development not only reflects the regulatory landscape’s responsiveness to emerging scientific evidence but also underscores the necessity for rigorous evaluation in the realm of pediatric healthcare. The outcome of these deliberations will have lasting implications for how gender-affirming treatments are approached in clinical settings, shaping the future of care for children facing gender dysphoria.
