Thank goodness, the MHRA doing their job. There’s a great bunch of scientists working there.
For anyone who isn’t clear (the media doesn’t do a good job of reporting it) you need approval from two bodies to get Clinical Trial Authorisation. One is the ethics committee (REC) approval, and the other is authorisation from the MHRA. The MHRA is the ultimate body which decides whether a medicine can be licensed in the UK on the basis of safety, efficacy and quality (NICE decides whether the NHS will pay for it in an entirely different assessment). It is the U.K. equivalent of the FDA in the USA, but by contrast to FDA it is very hands off in terms of setting social policy - MHRA is purely focused on safety, efficacy and quality and whether the potential benefit of the drug (or trial) outweighs the risk.
it sounds like the MHRA have recently been reviewing the clinical trial application, which is the dossier that KCL will have submitted to them in order to get authorisation to run the trial. It is very normal for clinical trials to be paused while MHRA’s concerns are addressed. Less normal for the concerns to be so fundamental to the study design at this stage of the game.
In the normal scheme of things, if you’re going to be running a clinical trial that could be problematic, you would request a scientific advice meeting with MHRA before you finalised your protocol. All these points would be thrashed out well in advance of the expensive business of preparing dossiers for them and the ethics committee (who will have to reapprove any amended protocol).
Now, in recent years, MHRA clinical trial unit have had a backlog of meeting requests and many study sponsors have just said fuck it, submit the clinical trial application anyway and argue the toss during the review period. Higher risk though, as KCL is finding out.