Bringing innovative trials to the UK

We spoke with the National Institute for Health Research’s (NIHR) senior business development manager, Anjna Rising, to learn how the NIHR is approaching innovative clinical trials and fostering partnerships between industry, the NHS and patients.

How is the NIHR adapting to new forms of clinical trials, like adaptive and virtual trials? Do you have any sort of processes in places to absorb these models into what you already do?

Innovative trial design is something which is an important area of work for the NIHR, and it was also highlighted in the 2017 Life Sciences Industrial Strategy. It is key for how we work with research charities. For example, we partner with Cancer Research UK to explore the use of adaptive trials through the Experimental Cancer Medicines Centres (ECMC) Network.

There is always going to need to be a transition period where we can test these models. But we're already seeing innovative designs being used and new types of trials being piloted in the UK within the NHS.

I also think that these models are not actually anything new, because collaborative research and earlier stage studies are often bespoke in many ways. It is more accurate to say that people are now trying to put labels to trials that have already been happening, trying to make them more standardised and make sure that the industry is open to carrying them out, despite the higher risk that comes from trying something new.

Are there any differences in how you work with smaller companies compared to larger companies?

We work with large companies, small companies, mid-tier companies – companies all across the board within the life sciences. We aren’t prescriptive about how we work with them, it's for the companies to say what support they need from us, and then how can the NIHR facilitate what their needs are. No matter how alike two companies will be, their needs can be completely different. There’s never going to be a one-size-fits-all solution. Every company has different advantages, disadvantages and growth areas, and it's about trying to identify them and work together to best support them.

The clinical trial landscape is evolving rapidly. Is the UK equipped to keep up with that?

Definitely. The UK has a strong history of clinical trials – we're innovators in that space. Our understanding of how trials run is on par with all the other leading countries, including the US, and the NHS is a fantastic place to access patients because it has an integrated health service. The NIHR is committed to continuing the great work that's happening in clinical research, and that's not just because it’s a good investment. It's also because it’s good for patients.

You’ve said that the NIHR is working more closely with the NHS around innovative trials. What does that involve?

The NIHR and NHS have been working together since we were established. The majority of our research centres are based in partnerships of leading NHS hospitals and universities, and most of our studies are run in the NHS. In terms of innovative trials, the NHS is very keen to engage and many of the clinicians and research delivery staff we support are active in this area. We need to identify what different pharma companies are looking for from the health service, and how having an integrated health service with rich sources of data can support innovative ways of running trials. The engagement happens at many different levels. It's within R&D teams, it's within clinical teams, it's even at a Trust level.

You can't always predict what new innovations are going to come in, so how does the NIHR keep itself adaptable for anything that might come in the near future?

It’s about communication. As well as supporting a broad range of companies around their product pipelines, we also work with a variety of stakeholders and market intel sources to scan what innovations are on the horizon. Examples of these include, NICE's PharmaScan and Healthtech Connect, NIHR's Innovation Observatory, various market intel databases and through developing closer relationships with the accelerators and healthtech clusters. The teams across the NIHR also attend numerous events key sectors around the world, work closely with universities and regularly interact with key opinion leaders. Our horizon scanning is multi-layered – we’re trying to look at everything that's happening in that space.

How exactly does the NIHR interact with patient groups and how does that affect the direction of your other work?

Patients want more involvement with the government’s decisions on where science and investment should be focused, so the government and Public Health England speak to patients because they want to understand where the biggest need is. The same is true in research. Patient and the public are involved in every aspect of the NIHR and all of our research. All of our facilities and centres have personnel dedicated to making sure patients opinions on health and research are heard and NIHR INVOLVE has led the way in embedding patient and public involvement and engagement in all aspects of the research process.

And do you see much interest in engaging patients in clinical trials from the industry?

Yes. It's amazing to see the work that they've been doing to engage patients. Most of them are at least open to doing it, and that’s the first step to productive partnerships. It has not always been that way, but I certainly see a shift. I work closely with both big pharma companies and the smallest one man bands, and they all care about it.

Anjna Rising was speaking at Medidata NEXT London.