Pioneering clinical trial service launched at PHTA

A unique approach to collaboration between academia and industry in clinical trials – led by world-leading expert in complex trial design and delivery, Professor Pam Kearns – has been launched by the Precision Health Technologies Accelerator (PHTA Ltd), promising to speed up the adoption of drugs and devices in the clinic.

The Industry Trials Hub (ITH) offers industry partners a new way to work with the University of Birmingham’s UKCRC-accredited clinical trials units to answer questions of unmet medical need, while also generating data that can contribute to the licencing of a medicine or regulatory approval of a device.

This ‘Fit for Filing’ approach will see the ITH work with industry and regulators such as the MHRA and FDA to ensure that its studies are designed and delivered with marketing authorisation in mind. The ITH also has the ability to run platform and adaptive trials, working with multiple partners to evaluate several medicines across different clinical trial phases, all within the same study.

Professor Pam Kearns leads the ITH and is also Director of the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU), which has been globally renowned for academic excellence for more than 30 years. She explained: “Our unit is one of the largest in Europe with extensive experience from small Phase I trials of new therapies right through to international multi-centred randomised trials. In establishing the ITH, we’re taking a significant step forward in our ability to improve the standard of care for patients alongside industry partners.

“The Fit for Filing approach to our collaborations with industry gives greater efficiency to the innovation pipeline. We can link our academic excellence and disease-specific clinical expertise with innovations from industry to deliver patient-relevant clinical trials that 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.”

Both the ITH and CRCTU are also committed to enhancing inclusivity and equality across its portfolio of clinical trials.

Professor Gino Martini, PHTA’s CEO, explained: “Birmingham is a ‘world within a city’, representing the global population in terms of its ethnic profile and socioeconomic demographics. The ITH will therefore be able to recruit ethnically-diverse representation in the majority of its clinical trials which is of great benefit to patients all over the world.”

PHTA is currently based at the Institute of Translational Medicine and the ITH is already in a position to design and consult on clinical trials before moving in to No1 BHIC late this year. To discuss capabilities, contact a member of the team.