Please add your name to the list of signatories!
We particularly invite signatures from:
- Students, academics, and staff at any U.K. university, especially King’s College London
- Medical Professionals
- Legal experts
- Politicians and members of relevant advocacy groups
"We are writing to express our profound relief that the planned PATHWAYS trial of puberty blockers has been paused, to urge leadership at KCL to use this period of reflection to reconsider its involvement, and to express our serious concerns about both the structure of the trial and the legal and reputational risks posed by KCL’s involvement.
Firstly, there are many methodological flaws with the design of the trial that bring into question its validity. These issues are particularly concerning given the vulnerability of the population this trial is being carried out on.
This trial is neither double-blinded nor placebo controlled. This is a significant methodological issue, given that the trial relies heavily on subjective outcome measures; children in the immediate-treatment group may for example report improvements due to the belief that they are receiving a beneficial intervention, while those in the delayed group may experience distress or disappointment precisely because treatment has been withheld. Any observed differences between the two groups may instead reflect expectations or emotional responses to treatment timing, rather than the effects of GnRHa itself. These risks are well recognised in clinical research, and are normally mitigated through blinding and placebo controls, and the absence of these substantially weakens the reliability of any conclusions drawn from this trial.
Another major issue with this trial’s methodology is its reliance on the KIDSCREEN-10 questionnaire as a primary outcome measure. KIDSCREEN-10 is a generic, brief, and broad measure of wellbeing, best suited for large scale population-level screening rather than evaluation of complex medical interventions. It is subjective and lacks the specificity required to meaningfully assess treatment-related outcomes, and so shouldn’t be considered an adequate way to measure the treatment’s efficacy. It also does not assess any of the potential adverse risks associated with GnRHa, as it contains no items capable of doing so, and will therefore be unable to provide any useful or relevant information regarding potential harms of puberty blockers. In addition, KIDSCREEN-10 employs a very short recall period of just one week. This makes the measure highly sensitive to transient fluctuations in mood or changes of circumstance, rather than any changes attributable to the treatment as short-term variations in wellbeing might be misinterpreted as evidence of benefit or harm, despite having no clear relationship to GnRHa treatment. This risk is aggravated by the fact that KIDSCREEN-10 relies entirely on self-reporting. Self-reporting is well known not to be fully reliable, with participants’ responses often influenced by expectations and beliefs about the treatment. While self-reporting can be very important in clinical trials, it is important that other measures of success are used as well, and this issue of unreliability is especially problematic in an unblinded trial such as this one. In the absence of blinding, self-reported improvements or deteriorations may reflect anything from placebo effects to disappointment in being part of the group that receives GnRHa after a delay."
Letter continues here plus add signature:
https://kclstopthepathwaystrial.online/