The Department of Health and Social Care has announced that the PATHWAYS TRIAL of puberty supressing hormones has been paused.
PATHWAYS TRIAL is a Clinical Trial of an Investigational Medicine Product (CTIMP) and was approved via combined review from the HRA and a Research Ethics Committee entirely independent of the research team, sponsor and funder; as well as the Medicine and Healthcare products Regulatory Agency (MHRA) as medicines regulator.
The REC reviews its ethics opinion if new information is received about a trial which might have changed its original decision. This includes anything which leads to amendments to the trial design and which might be submitted to or required by MHRA. MHRA has also shared information about its active scientific dialogue with the trial sponsors . Amendments, or changes to a study, must be reviewed and approved by the REC to ensure that the study still has ethics approval.
As the PATHWAYS study has been paused, we will review the study again, in line with our standard operating procedures, before it can restart. We continue to work closely with MHRA to manage and respond to concerns raised about the trial.