Transforming the early-stage clinical research environment in the UK
The experience of the pandemic has underscored the importance of clinical trials in the rapid development of the medicines needed to improve global health. During the COVID-19 vaccine development process, the UK adopted faster and leaner processes for rolling out clinical trials without compromising patient safety. Using what we learned from the pandemic as our ‘peacetime’ norm would have a hugely positive impact on meeting patient needs faster and at a lower financial cost.
Silence Therapeutics is developing new genetic-based medicines using mRNA technology and the ability to conduct early clinical trials at pace in a safe environment is a key decision-making step to making our new medicines available to patients.
There has been a recent trend in the relative number of early phase trials in the UK falling and the time to conduct them increasing, compared with competitors. This is counterintuitive since the UK has such strong credentials in basic science, enabling technology, a highly respected regulatory agency, government investment in academic clinical research facilities, excellent commercial phase I units and the potential to leverage the unique patient resource of the NHS.
In a recent podcast with the Foundation for Science and Technology, Sir Gordon Duff, former Chairman of the MHRA, and I, discussed the reforms that the UK can implement to address the downward trend in the number of first-in-human studies taking place in the UK during recent years.
The UK can take inspiration from policy developments around the world. Australia has introduced a generous R&D tax credit system, and Spain has streamlined its clinical trial approvals and site set-up process. These measures have played their part in enhancing the reputation of these countries as destinations for early-stage research. Following the departure of the UK from the EU there is now an opportunity for the UK to create a unique seamless offering that utilizes the best of our academic, technological, commercial, regulatory and NHS resources.
There is agreement that regulatory policy must keep pace with the advent of precision medicines. Many modern therapeutics use sophisticated technologies that did not exist when the current regulatory framework was established back in the thalidomide age. As a result, today’s regulatory regimes are very well-suited to dealing with conventional medicines with less-specific actions and the risk profiles associated with them, but may not be fully suited to new, highly-targeted medicines. The MHRA has the history and international standing to pioneer a new risk-based approach based on modern sciences and should be supported to take a leadership role in achieving this at an international level.
We also need to improve the availability and depth of clinical development and regulatory expertise within the UK. The high degree of specialisation in modern drugs requires the existing and future workforce to be equipped with expert knowledge.
The UK has a huge opportunity in front of it. It’s time that reforms are made to enable the UK to become a global bioscience superpower.
Giles Campion M.D., Executive Director, Silence Therapeutics
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