Drug development is the cornerstone of introducing new medicines. The process concerns bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. In many cases there are novel and innovative ideas, the delay in most processes is with bringing new medicines to market.
In addition to costs, administrative hurdles are also problematic and this contributes to the high failure rate of new drug candidates.
The final stage is with the clinical trial. Clinical trials are research studies that test a medical, surgical, or behavioural intervention in people. Such trials are the primary way that researchers can demonstrate to government regulators that a new form of treatment or prevention, such as a new drug, diet, or medical device is safe and effective for use in people.
A new collaboration between academia and industry in the clinical trials space is set to help to bring drugs to market faster. The change is being led by an expert in complex trial design and delivery: Professor Pam Kearns. The project is being operated in partnership with the Precision Health Technologies Accelerator (PHTA Ltd).
Referred to as the Industry Trials Hub (ITH), the new approach seeks to provide a new way to work with the University of Birmingham’s clinical trials units, with a focus on answering questions of unmet medical need. A second focus is on generating data that can contribute to the licencing of a medicine or regulatory approval of a device.
The so-termed ‘Fit for Filing’ approach will see the ITH work with industry and regulators to ensure that its studies are designed and delivered with marketing authorisation in mind.
According to Kearns: “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.”
The idea behind clinical trials hubs is to provide resources on the design, conduct, analysis, and knowledge transfer and exchange for randomised controlled trials, observational studies, and meta-analyses.
