The MHRA 2026 Clinical Trial Update: Reflections from a Panel Discussion

I recently had the chance to host a panel discussion on the MHRA clinical trial update with focus on the retention of essential records and the big jump from 5 years to 25 years, I genuinely enjoyed it. 

What made it particularly valuable wasn’t just the topic itself (although it’s a big one), but the range of perspectives in the room. We had voices from a GxP consultancy, the NHS, and a Chief Technology Officer specialising in digital archiving and preservation. Bringing those different viewpoints together made for a really rich discussion and highlighted just how multifaceted this challenge is. 

And if there was one theme that kept surfacing throughout the conversation, it was this: 

We’re not as ready as we think we are. 

A shift that’s bigger than it looks 

On the surface, the MHRA update might seem like a simple extension of existing rules. The headline change moving to 25-year retention of clinical trial records sounds like just “more of the same.” 

But the more we unpacked it, the clearer it became that this is not just about keeping records for longer. It’s about fundamentally rethinking how those records are managed, stored, and crucially preserved over time. 

One of the panellists described it as a digital preservation challenge, and that framing really stuck with me. Because storing something for 25 years is one thing. Ensuring it’s still readable, usable, and trustworthy after 25 years is something else entirely. 

The gap between sponsors and sites 

Another interesting dynamic that came up was the difference in preparedness between sponsors and sites. 

There was a general sense that larger sponsors particularly those operating internationally are likely to be in a better position. They’ve had more exposure to evolving guidelines and, in many cases, more resources to adapt. 

Sites, on the other hand, may face a steeper climb. Not because of a lack of capability, but because of real-world constraints: time, staffing, governance processes, and competing priorities. 

It’s not that people aren’t aware change is coming. It’s that turning that awareness into operational readiness updated SOPs, trained staff, aligned systems takes time. And time is something many teams don’t have in abundance. 

Digital is where things get difficult 

During the session we talked about everything from USB sticks in safes to files sitting in shared drives or SharePoint, untouched after a study ends. These approaches might feel secure in the short term, but over decades, they introduce real risks. Systems change, formats evolve, access gets lost, and suddenly data that once existed becomes difficult or impossible to retrieve. 

That’s where the idea of preservation, rather than just storage, becomes so important. It’s not enough to save something and assume it will still be there in a usable form years down the line. 

A cultural shift, not just a technical one 

What became clear as the conversation progressed is that this isn’t just a technical challenge it’s also a cultural one. 

For a long time, archiving has been treated as something that happens at the end of a study. You close out, tidy up your documentation, and move on to the next project. 

But that mindset doesn’t hold up when you’re thinking in 25-year timeframes. 

There’s a growing need to consider long-term archiving right from the start. To think about how data will be structured, stored, and maintained before the study even begins. That requires a shift in how teams plan, how they prioritise, and how they think about responsibility. 

It also brings training into sharper focus. You can have the right processes on paper, but if people aren’t familiar with them or don’t fully understand what’s changed there’s a real risk of inconsistency. 

The messy reality of transition 

We also touched on the transition period, which, in many ways, feels like where the real complexity lies. 

Organisations will be navigating a mix of old and new rules at the same time. Some trials will fall under previous retention requirements, others under the new 25-year rule, and overlaying all of that are updated guidelines that may apply more broadly. 

It’s not hard to imagine how confusion could creep in. Even small misunderstandings around which rules apply where could lead to gaps or inconsistencies in how records are managed. 

The risk of “set and forget” 

If there’s one risk that stood out to me personally, it’s the temptation to treat this as a storage problem rather than a lifecycle problem. 

It’s very easy to think: “We’ve saved the files, they’re in the system, job done.” 

But as we heard during the panel, many of the systems organisations rely on today simply aren’t designed for decades-long retention. Leaving records in place without actively managing them introduces a slow, invisible risk. 

Nothing breaks immediately. There’s no obvious failure. But over time, things drift until the moment you actually need the data, and it’s no longer usable. 

Looking ahead: risk and opportunity 

A lot of the discussion focused on risk understandably so. There are clear regulatory, operational, and even patient safety implications if records aren’t managed properly. 

But what I found equally interesting was the flip side. 

If organisations get this right if they invest in proper preservation, governance, and long-term thinking there’s a huge opportunity. Decades of clinical trial data, properly maintained, could become an incredibly valuable resource. Not just for compliance, but for research, innovation, and even future technologies like AI. 

Final reflections 

Hosting this panel really reinforced something for me: this change is about rethinking how we value and manage data over the long term. 

There’s still time to prepare, but it will require more than small adjustments. It calls for a more deliberate, joined-up approach across people, processes, and technology. 

And perhaps most importantly, it requires us to move away from thinking of archiving as an endpoint, and start seeing it as an ongoing responsibility. 

If you missed the panel discussion, you can access the recording here