A senior scientist leading a groundbreaking NHS trial that will administer puberty blockers to children as young as ten has expressed her pride in overseeing the controversial study. Professor Emily Simonoff, Chief Investigator of the research, confirmed the trial received regulatory approval yesterday despite significant opposition from campaign groups.
Landmark Study Details and Methodology
The trial forms part of a substantial £10.7 million 'Pathways' research programme and represents the first comprehensive study examining potential brain development impacts of puberty suppressing drugs on young people. According to Professor Simonoff, who serves as Professor of Child and Adolescent Psychiatry at King's College Hospital, 226 boys and girls under 16 will participate in the research, with approximately half receiving the medication.
Participants will undergo intensive medical and psychological screening before being selected from those currently accessing gender services. The study design involves administering puberty blockers for up to two years while monitoring participants until they reach early adulthood, with final findings expected to take approximately four years to compile.
Scientific Scrutiny and Safety Measures
Professor Simonoff emphasised the rigorous oversight governing the trial, stating: "This study has gone through all the usual approvals and regulatory scrutiny which involves the Human Research Authority and the Medicines and Healthcare Regulatory Agency (MHRA)." She highlighted that the UK maintains very high levels of scrutiny for clinical trials to ensure proper conduct and participant safety.
The research will specifically investigate potential risks to brain development through cognitive assessments measuring thinking, learning and memory. For the first time, researchers will conduct brain scans comparing young people receiving puberty suppressing hormones against those who aren't. The study will also evaluate the balance between possible mental health benefits and quality of life improvements against potential physical health risks and harms.
Controversial Background and Legal Challenges
The trial's approval follows last year's ban on routine use of puberty blockers after the landmark Cass Review, led by Dr Hilary Cass, concluded insufficient clinical evidence existed to determine whether the drugs were dangerous. Dr Cass faced vile online abuse following her findings and was advised to avoid public transport due to safety concerns.
Opposition to the new trial has been swift and vocal. Maya Forstater, CEO of sex-based rights charity Sex Matters, condemned the research as "foolish and unethical" and warned it could cause irreversible lifelong harm. Campaigners have threatened legal action to prevent the trial from proceeding, which is expected to begin in the New Year.
Professor Simonoff acknowledged the polarised views surrounding gender treatments but stressed that "right in the middle there are young people and their parents who are attending services, who have gender incongruence and who don't know what to do." She expressed hope that the trial would provide much-needed evidence for families and healthcare providers.
This trial represents the only pathway for under-18s in the UK to access puberty blockers following the closure of the controversial Tavistock Gender Identity Development Service in London last year, which had been prescribing the drugs to young children since 2011.
