This is about trials, I promise, but first, let’s start with the music of David Bowie. One thing that many commentators said following his recent death was that he never followed trends, he created them. Every few years he would unveil his latest creation, sometimes to the horror of his fans, as when he killed off Ziggy Stardust at the height of his fame, but always creating something new. Right until the end, the same artist, but creating new art to surprise us. And that’s what I’ll miss, that in the next couple of years through the banal beats, he won’t suddenly reappear with his latest creation. Now compare Bowie with the Spice Girls. Massively successful yes, a prominent icon of a specific era, but firmly grounded in that time.
And that’s one of the fundamental problems with ICH-GCP, it belongs to another era, twenty years ago to be precise, 1996, when the Spice Girls album above was released. A time before the connectivity that we take for granted today. A time when it looked as if the only players in the arena of randomised trials were industry, who developed the new drugs, and the regulators, who reviewed those industry trials and then, hopefully, approved those new drugs. A time when the doctors who cared for us were given a certain deference, which meant that we didn’t question their decisions, so that the people who took part in trials, are not participants, but rather “subjects”.
If you’re thinking that’s hardly fair comparing trial regulation with music, I’d say that many aspects of research regulation have kept pace with change. A good example is the ethical framework laid out in the Declaration of Helsinki.
Not perfect, but one of the reasons behind its universal adoption around the world is that it is grounded in solid ethical principles, but there is a recognition that things change, so every decade or so, an expert group produces a new draft. This new version is grounded in those foundational principles, but it adapts to embrace new areas of research, such as in the latest version, which includes guidelines on doing research in emergency situations or in people who have lost mental capacity. Very Bowie like.
Trialists have transformed the way trials get done in the last decade or so, drawing on the latest technological developments, always looking for better ways to get trials done. This might involve taking ideas from completely unrelated areas, such as car manufacturing, by taking Toyota’s concept of quality management and adapting it to trial monitoring to focus on those errors that matter. Bowie did the same at one time taking concepts from Japanese theatre.
When we first heard rumours a couple of years back that ICH after twenty years were working on an update to ICH-GCP, we tried in vain to find out more details. Then June last year, the proposed update was released, but it wasn’t new, the original text was still there with ICH insisting it was “still correct”, that the many problems it had caused were not the result of the fundamentally flawed document itself, but rather the “interpretation” of it. That would be like saying to the police officer who pulls you over for speeding, “Oh sorry officer, I never realised those maximum speed signs meant you couldn’t go faster than that.”
I also heard another rumour recently that the Spice Girls might be getting back together, but it doesn’t excite me. Because like the recent update to ICH-GCP, they are stuck in another time, so I would doubt that they will genuinely surprise us with something new. But that’s even better than ICH’s recent update, which by refusing to update the original text and just adding new text alongside it, introduces all sorts of contradictions and confusion. It’s a bit like a really bad cover version.
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