Pathways Study: Puberty Suppression Debate
Full Debate: Read Full DebateLayla Moran
Main Page: Layla Moran (Liberal Democrat - Oxford West and Abingdon)Department Debates - View all Layla Moran's debates with the Department of Health and Social Care
(1 month, 1 week ago)
Commons ChamberI call the Chair of the Health and Social Care Committee.
I welcome the statement and this approach. I thank the MHRA for engaging with the Committee when we asked it specific questions about this. It told us that the role of the regulator is to ensure that participants in any clinical trial are kept safe and are exposed to medicine only if there is a reasonable expectation of a positive effect, and that is what was foremost in its mind. It also reassured us that if it had not felt 100% assured, it would have not allowed the trial to go forward.
There was a lot of disquiet about the iterative process that the trial has gone through—that it was stopped, paused and then started again. Could the Secretary of State outline for the House how usual or unusual that is? What support can the NHS offer those families who might have hoped to be part of the trail but now find themselves excluded from it?
I am sure that the hon. Lady will agree that this is now one of the most heavily scrutinised clinical trials in this country in recent history, and rightly so—it is right that it is so heavily scrutinised and that we all seek assurances about the safeguards in place. It is right that, as Health Secretary, I made sure that I got those detailed safeguards before coming to the House to set out the Government’s position today.
The hon. Lady asked how usual it is for the MHRA to work with the sponsors of trials. My understanding is that the MHRA routinely works with trial sponsors to iterate the protocols in relation to those trials. Because this trial involves children and young people, for me, the bar should be exceptionally high, to ensure that those safeguards are in place. That is why, although my starting principle is that clinical evidence is the right way to approach such a matter, I wanted that extra reassurance. That is why I asked for the most detailed possible assurances from my clinical advisers, to ensure that those robust safeguards are in place in the way the trial is now designed.