UK Research Regulator 'Clears' Puberty-Blocker Trial

Tim Locke

October 15, 2019

Concerns over a trial of puberty suppression in adolescents with gender dysphoria have been partly dismissed by the NHS Health Research Authority (HRA).

Puberty blocking is used to help delay future decisions on gender reassignment.

The regulator began an investigation in July after concerns were raised by the BBC's Newsnight programme about the NHS Gender Identity Development Service (GIDS) and early access to puberty blockers.

Concerns were also raised about the treatment possibly causing suicidal thoughts.

GIDS told Medscape News UK it moved to offering puberty blockers from Tanner stage 2 after nearly a decade of consultation with international experts. It said the research protocol was designed at the same time to increase the growing international evidence base. 

The Service has bases in London at the Tavistock Centre and in Leeds.

'No Significant Problems Found'

The HRA has now published its report into the unpublished trial 'Early pubertal suppression in a carefully selected group of adolescents with gender identity disorders' .

The term 'gender identity disorder' used when the trial started has since been replaced with gender dysphoria.

The HRA said its investigation "did not find any significant problems with the study or the research team".

However, "suggestions" are made which it said "could help to prevent confusion in the future".

These included improved version labelling of research documents, and careful consideration of the terminology used.

In future, the HRA should also review the requirement for research teams to produce annual progress reports, and management of declarations of interest.

"Overall the research team involved in the design and delivery of the study, worked in accordance with recognised practice for health research, and we find no cause for concern about the oversight of the study by the sponsor or chief investigator," the HRA said in a statement.

The HRA made clear the investigation only covered the research, not the clinical service provided by the Tavistock and Portman NHS Foundation Trust, where the study was based.

Trust 'Welcomes Findings'

In a statement the Trust welcomed the findings. A spokesperson said: "The Tavistock and Portman takes the integrity of its clinical practice and research very seriously. Our work conforms to the highest legal, ethical and regulatory standards and our priority is the safety and wellbeing of our patients at all times.

"The early intervention study was undertaken after nearly a decade of consultation with international experts, was fully approved by a research ethics committee and has followed good research practice. The study group has presented interim data at professional conferences since 2015 and the full study results will be published in a peer-reviewed journal in line with international best practice.

"We welcome the findings of the HRA report, which concludes that the researchers worked in accordance with recognised practice for health research, and in some areas, such as patient involvement and transparency, were ahead of normal practice at the time.

"The GIDS is one of the longest-established services of its type in the world with an international reputation for being cautious and considered. Our clinical interventions are laid out in nationally-set service specifications. The Care Quality Commission (CQC), our care standards regulator, and our national commissioners, NHS England, monitor our service very closely. The Service has a high level of reported satisfaction and was rated Good by the CQC."

Editor's note: This article was updated to include additional information supplied by Tavistock and Portman NHS Foundation Trust.

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