24-25 - Past, present and future

This summer marks twenty years since I helped to establish a clinical trials unit in a partnership with St George’s, University of London. In that period, the clinical research sector has changed significantly. This change reflects the evolving world around clinical research – in the pharmaceutical industry, in government, in regulation and in healthcare provision – and this evolution will continue. Our industry will have to follow.

By 2001, the early phase trial unit I established – Richmond Pharmacology – was one of the last to be founded in the UK and there were already well over 60 in place. I sought to do something different and to create new clinical study infrastructure: a unit nested in a hospital setting – at St George’s – allowing clinicians to participate in high end studies. We then intended to use the profits to either invest in the company, or fund academic research. Twenty years later, and the model has not changed – we recently established the Richmond Research Institute to provide a formal setting for that academic research, using our commercial research to finance projects in under-researched areas.

While the world around us has changed, the importance of early phase research in the UK has not. Every early phase trial conducted in the UK leads to further research opportunities for the life sciences sector. Figures from the National Institute for Health Research (NIHR) show that clinical research is worth £2.7 billion a year – including £1.5 billion from commercial sources – and supports more than 47,000 jobs. This is hugely significant for the economy and outlines why attracting investment in early phase research is so important.

Moreover, the UK has a combination of qualities few other nations can compete with – a huge database centralised through the National Health Service, offering cradle-to-grave medical records to support patient selection and enrolment, and several of the world’s top scientific universities located in London, Oxford and Cambridge. This combination of sheer capacity and expertise makes the UK and London hugely competitive in the market. This has been the case for decades past and will continue to be so in the future.

Nevertheless, there have been huge developments to the way our industry operates in that time. At the beginning of the century, our work was a more industrialised, narrowly regulated part of the drug development process, screening many small molecules for therapeutic application – akin to finding a needle in a haystack. Now, our trials are very different. We more commonly analyse molecular biology compounds which are designed specifically to intervene in a known disease pathway; an example of this is our recent study with Intellia Therapeutics to apply CRISPR technology to treat amyloidosis. This means that the whole process is quicker, but also much more focused on efficacy in relation to patient outcomes. This does not just represent a change in process, it requires different skills, new ways of working and training programmes that keep clinical pharmacologists in keeping with the latest practices.

The pharmacology workforce must keep up or the UK will find itself bested by other markets. If the workforce cannot deliver the demands of today’s clinical research, pharmaceutical companies will look elsewhere for those who can, taking its investment with it. The workforce is the lifeblood of our industry and it must continue to be the best in the world.

And of course, as the industry evolves the policy and regulatory environment changes too. Throughout my time in industry, the Medicines and Healthcare products Regulatory Agency (MHRA) has continued to be the most innovative and respected regulatory agency in Europe. Its advice is globally accepted, its reviews are thorough and constructive, and it is prompt.

A formal quality system leading to accreditation for clinical trial units to perform first-in-human trials is still unique and provides surety to sponsors and the public that standards are high. I’m proud to have led the first early phase research organisation to receive MHRA standard and supplementary accreditation for two clinical trial units. Nevertheless, that this regulatory system must continue to evolve is no secret. Matt Hancock himself said as much at the Association of the British Pharmaceutical Industry (ABPI) annual conference on April 29, highlighting its need to reflect the changing research environment. The MHRA will have to continue setting the global standard, not least following the UK’s departure from the European Union, given its expanded role and new position in the global regulatory landscape.

The future of medicines is in more advanced, more sophisticated and more personalised treatments. The future of clinical research therefore follows suit. There is still an opportunity for research organisations to set the standard and define best practice for research in personalised treatments, gene therapies and similar studies. Research organisations need sophisticated patient enrolment networks to ensure they can meet the needs of pharmaceutical companies, and they need the skills to deliver effective, safe and efficient trials. The greater trial complexity requires much more sophisticated working processes for managing trials and improved IT infrastructures allowing rapid data visualisation. Moreover, regulators must be adaptable to meet the needs of these studies, just as the MHRA has been in recent years, for example by seeking to understand the needs of patients through patient engagement forums. Our industry, our regulators and our health service must all keep pace with the global standards in this area as it emerges as one of the key battlegrounds for world-leading markets to compete for investment.

The work of the Clinical Pharmacology Skills Alliance (CPSA) is helping to equip the next generation of clinical pharmacologists with the skills they need for the future to ensure that the UK remains a leading destination for research into these new waves of therapies.

I would like to see more examples of collaboration within the UK clinical research community (alongside government and regulators) to help maintain the country’s leading position in life sciences. I would encourage my peers to consider how our industry as a whole can adapt to ensure the UK remains the destination of choice for pharmaceutical companies looking to place their studies, for example, by the formation of specialised research clusters like those in the US. I would also encourage the MHRA and others in government and regulation to continue the dialogue about this evolving industry and the future of research.