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International Clinical Trials Day: A chance to debate the future of innovation

Posted by
Iris Loew-Friedrich, Patient Value Development Solutions

Whilst markers like International Clinical Trials Day are an important moment to recognize our shared clinical challenges and opportunities, the reality is, these thoughts are never far from our mind. At UCB, one of our biggest drivers is our mission to enhance and evolve our clinical capabilities to bring life-changing innovations to our patients.

What International Clinical Trials Day does is allow us an opportunity to raise our heads above the everyday and take stock of our longer-term ambitions for clinical innovation. As a scientist, I relish the opportunity to look towards the future, and provide my insights on some of the most fundamental changes we’re striving towards, in and out of the lab.

The power of data

A key focus area is the evolution in our understanding of the power of data globally, increasing the types of data we can examine, from basic science to healthcare resource utilization information. The sharing of data could be understood as a universal drive to improve medical science. And whilst every citizen would feel a commitment to contribute data, companies, academia and government institutes would sign up to a global obligation to maximize the use of data in a responsible way for the benefit of all.

Patient experience prioritization

From the patient perspective, I see the way we design trials changing for the benefit of the participants, mirroring daily clinical practice as much as possible to ensure a diverse population can participate. Transitioning from everyday healthcare to participation in a clinical study will be seamless in the future and provide an identical experience so that clinical studies are fully integrated into care. Currently, only 5% of potentially eligible patients participate in clinical studies and this challenge is slowing down innovation. Integration of clinical studies into care will change this. Study protocols will be designed with patient needs and patient burden as the first consideration, with regulatory requirements and scientific curiosity following this priority. Patients should be able to participate from home, submitting results digitally with real-time communication and support to maximising efficiency and patient experience, and minimise the cost and carbon footprint of large-scale trials.

A truly virtualized approach

The increase of virtualized trials can further address clinical challenges, reducing the need for large patient enrolment. Artificial intelligence tools and data assets collected in one digital library could combine current patient data with historical information from earlier trials to enable robust testing with a limited cohort.

Safety-centric monitoring

Safety data could also be measured in a constant and standardized manner across the industry. Apps validated by independent scientific groups, approved by regulators and usable across all clinical studies could mean that all data related to a medicine and its control group are routed in real-time to an independent data monitoring committee. At pre-defined milestones, analyses could be performed and communicated to the clinical team and regulators, improving regulatory science and decision making.

A culture of collaboration

From a regulatory standpoint, I hope that a culture of partnership will continue, that interactions with regulatory agencies are frequent, collaborative, with transparent sharing of information, and joint evaluation of next steps.

With our industry and the world, we operate in constantly changing, there’s a healthy amount of educated speculation when we think about the future of clinical trials. But I have ultimate confidence that UCB will be at the forefront of the effort to evolve and improve the industry’s approach to innovation, for the benefit of the patients we serve.

Find out more about our passion for innovation here: Innovation is | UCB


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