With all complex clinical trials, MHRA's top priority is the safety and wellbeing of the trial participants
An MHRA spokesperson commented:
With all complex clinical trials, MHRA's top priority is the safety and wellbeing of the trial participants.
It is part of the usual process that clinical trials are kept continuously under review and for us to have active scientific dialogue with the trial sponsors.
The safety and wellbeing of the participants to be recruited into the PATHWAYS clinical trial is paramount, particularly in view of the age of the children and young people who may be involved. For this reason, the MHRA is applying the highest scrutiny and taking a cautious and measured approach. We have raised some concerns related to the wellbeing of participants and scientific dialogue will now follow with the trial sponsor. We rely on the best scientific evidence to ensure all trials are as safe as possible for those participating.
