UK puberty blockers trial: The full study protocol

The PATHWAYS trial of puberty blockers for transgender youth in the UK has received ethics approval and the protocol is now publicly available.

The full trial protocol can now be found on the website of King's College London (permalink here).

According to the website of the UK's ethics regulator HRA, the trial received ethics approval in early November. It is unclear whether it has also secured approval from the UK's medicines regulator MHRA. So far, the trial has not been registered on the ISRCTN clinical trial registry.

The BBC reports that:

"As a result of the uncertainty over the safety of the drugs, highlighted by the Cass review into gender care, led by paediatrician Dr Hilary Cass, doctors can now only offer the treatment to under-18s as part of a research study."

"Last year, the government brought in a UK-wide indefinite ban on the drugs being prescribed privately or by the NHS to children and young people questioning their gender identity."

"The new clinical trial, called Pathway, will involve children who are currently accessing gender services and have a diagnosis of gender incongruence."

Transparency aspects

TranspariMED previously called for the draft protocol to be made public before ethics approval to enable external experts to comment on the draft study design. That horse has now bolted.

According to the protocol:

"The primary and secondary outcomes will be published in a peer reviewed opensource medical journal within 12 months of the end of trial. Recruiting sites will be informed of the results and will be asked to disseminate the findings to participants. Patient groups will be informed of the results for dissemination among their members."

"When the study is complete, a data sharing dataset will be created from the raw data by the study analyst, which will not include any other identifiable data and study PIN will be altered so that individuals are not recognisable from the dataset."

"Data will not be available to other parties during the period of data collection and analyses and publication addressing the objectives outlined above. Following completion of the study and publication of these results, consideration will be given to providing anonymised data to other researchers following a written application."