Time trials

The collective landscape of academia-industry clinical trials is undergoing a period of transformation in response to last year’s O’Shaughnessy Review.

Birmingham – a prominent hub for clinical trials – is spearheading this change through the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU) and the Precision Health Technologies Accelerator (PHTA).

Globally renowned for academic excellence for over 30 years, the CRCTU is one of the largest in Europe with extensive experience from small phase I trials of new therapies, through to international multi-centred randomised trials.

Traditionally, academic-led trials partnered with industry to answer research questions driven by clinical investigators in the hope of changing clinical practice and generating academic publications.

In these trials, the industry partner’s role is limited to providing the drug and sometimes a small amount of funding for trial delivery.

These trials are delivered to good regulatory standards, but the data generated is not always suitable for drug licensing or licence label changes.

The PHTA Industry Trials Hub (ITH), operated by CRCTU’s clinical experts, aims to change this relationship – promising to speed up the adoption of drugs in the clinic through a new approach we call ‘Fit for Filing’.

The Industry Trials Hub offers industry partners a new way to work with our UKCRC-accredited clinical trials units to answer questions of unmet medical need.

It also generates vital data that can contribute to the licensing of a medicine – working with industry and regulators such as the MHRA and FDA to ensure our studies are designed and delivered with marketing authorisation in mind.

‘Fit for Filing’ gives greater efficiency to the innovation pipeline, linking our academic excellence and disease-specific clinical expertise with innovations from industry to deliver patient-relevant clinical trials.

Subsequently these studies can directly contribute to market authorisation, providing a more rapid pathway to clinical adoption – which is great news for patients and great for the UK life sciences sector too.

What’s particularly important about doing this work in Birmingham is that it is a ‘world within a city’, representing the global population in terms of its ethnic profile and socio-economic demographics.

The ITH will therefore be able to recruit ethnically diverse representation in the majority of its clinical trials, going a long way towards ensuring that the innovations developed here are inherently suitable for communities worldwide.

This new way of working is already being recognised within the sector, with a major trial supported by the ITH recently receiving a nomination in the Further, Faster, Together (Industry-Academia Collaboration) category at the Cancer Research Horizons Innovation & Entrepreneurship Awards 2024.

The award category celebrates the promotion of innovation in oncology through industry and academia working together.

Furthermore, it recognises outstanding examples of teamwork with clear evidence of knowledge transfer between the different sectors and organisations, while demonstrating how value and impact is maximised through working in partnership and collaboration.

And that’s precisely what we are beginning to achieve through the Industry Trials Hub.