Thread by @bengoldacre

Today has seen a gigantic global fuss about the woeful state of devices regulation. The Royal College of Surgeons has come out and said things need to change. What's gone wrong, and why does it take *journalists* to point it out, rather than regulators / researchers?

Thread..

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Firstly, and this is the key problem: essentially, nobody is paid to look at medicines and devices regulations, check compliance, and critically review our frameworks to see if they're up to scratch.

Where is the NIHR "Regulatory Science" funding stream? Nowhere...

.. pretty much all the papers you see on problems with medicines/device regulations, by folk like @carlheneghan and me, and others, are done in "weekend and evening" time. They're not funded. You sneak them in. They are derrogated by the system to the status of *hobbies*....

@carlheneghan ... this approach by funders, regulators, universities, the state, is absolutely guaranteed to produce regulatory catastrophes. These are technical issues. You need people with clinical, academic, epidemiology, and policy skills, critically reviewing these regulations..

@carlheneghan ... to check that they are fit for purpose, and checking compliance. This is difficult, skilled, time-consuming work. It is not about being a radical outsider vagabond. It's about being an independent thoughtful assessor of whether things are working right, which we have...

@carlheneghan ... across all of medicine, but mysteriously in the UK not for medicines and device regulations. This work will not happen by magic. It cannot be done for free.

NIHR could launch a Regulatory Science funding stream and transform the landscape, radically improve patient safety..

.. Why does no university have a "Centre for Regulatory Science"? Or three? Competing to obtain funding, supporting regulators to achieve their objectives, learn from mistakes of the past, help devise better ways to avoid future problems, monitor compliance, and so on...

... And remember, this is not about catching regulators out, or companies. In fact, a Centre for Regulatory Science, adequately funded, would be pointing out to MHRA, HRA and other bodies how they can be needlessly obstructive for researchers and innovation, and how to fix that..

... So, that is my pitch for the day.

An NIHR funding stream on Regulatory Science.

A goal of three Centres for Regulatory Science before 2021.

Routine monitoring of compliance with key regulatory objectives (trial reporting, post approval trials, etc).

And most important..

.. sophisticated, informed, technical, critical review of existing regulatory approaches to drugs and devices, with positive worked suggestions about how they can be improved, with strengths and weaknesses all round.

We could do that at the drop of a hat.

Or, OR...

...OR...

We can just carry on, business as usual, wait for the same failures to repeat themselves as patients are needlessly harmed. Rely on the occasional academic to occasionally point out some problems, rushed, in their spare time. Rely on journalists to address the issues..

.. We can have meetings where bigwigs share general platitudes because nobody's actually paid to specialise in the area. Maybe in such huge volumes that the rare academics who do helpful hobby work in the field can't even go, or be represented, at them all...

...Those are our 2 futures.

I think today's blanket international media coverage on widespread shortcomings in device regulation should be viewed as a wake up call for positive action. Not a storm to be weathered.

Start with an NIHR funding stream on Regulatory Science.

ENDS