Ulrike Lorch explores how investing in the progress of the clinical research workforce is crucial to delivering high quality, cutting-edge trials and achieving faster drug development that patients ultimately benefit from

It is an exciting time to enter the clinical research profession and the UK stands to gain by facilitating flexible and specialised training programmes for the new wave of medical practitioners and scientists.

Leaders in clinical research such as myself are preparing the tailored learning environment that enables trainees not to follow a ‘one-size-fits all’ model. Instead, we are preparing them to work on the most advanced scientific technologies including, for example, personalised medicines and gene therapies.

This is not only important in meeting the needs of drug developers and in-need patients, but on a macro level, it also allows the UK to remain a world-leading location to conduct clinical trials. If the UK retains top-level clinical researchers, then it will continue to attract a high volume of groundbreaking studies from international drug developers, which will benefit the local patient population.

Now and then – how specialised training has evolved

Comparing the development opportunities now for clinical researchers with my training, the situation is very different. When I trained there was no speciality training in pharmaceutical medicine or a defined curriculum, but I – and others like me – had the opportunity and challenge to develop our own modular training, tailored to the work we were doing or intended to do.

I was fortunate to have mentors such as Professor Brian Prichard, Professor Andre Mclean and Professor John Camm to develop the skills I needed to become a clinical pharmacologist. However, learning from these individuals was not predetermined and my peer group had to craft this on an ad hoc basis, which required greater effort as there was no predefined pathway to follow.

I am delighted that the new Pharmaceutical Medicine Specialty Training (PMST) curriculum 2021 by the Faculty of Pharmaceutical Medicine (FPM) enables doctors to apply their learning in any clinical research setting. Within my organisation – and others that follow this programme – trainees undertake a three to four year programme and at my organisation they choose a special interest from year 2 onwards.

Each doctor develops in different areas depending upon their personal interest this is empowering for ambitious and curious medics. The flexibility built into modern training programmes recognises the vast amount of knowledge needed to practice modern clinical pharmacology but also empowers medics to pursue a couple of therapy areas in the depth that is required if they are to become principal investigators in early phase clinical research or experts in other areas of the PMST curriculum.

Training is significantly more practical than it used to be. While gaining an understanding of the scientific drivers is crucial in training, this practical engagement allows doctors and scientists to be surrounded by those with the experience and knowledge, and to learn by doing. In the same way an apprenticeship does, these programmes – more so than ever – prepare medical and scientist trainees for the realities of working in research, drug development, or indeed, a clinical career.

Another recent change is that training has shifted away from rigid regimens and towards a modular approach. For those curious in exploring specific career paths, they can now undertake a core set of foundational training modules to give them the necessary building blocks for a career in clinical pharmacology. These foundation modules can be similar for doctors and scientists, which make training more efficient.

Trainees can then supplement this with modules of particular interest and /or with more in-depth training in certain foundation modules, that will enable them to build quite individual careers. It allows clinical researchers to pursue career journeys best suited to them, where their specific capabilities can add value.

I am personally involved with numerous initiatives to create an improved and flexible training environment for clinical researchers. I am proud to be a member of the trailblazer group developing the MSc Apprenticeship for Clinical Pharmacology Scientists within the Clinical Pharmacology Skills Alliance (CPSA). The CPSA was only established in 2017 and aims to deliver a long-term action plan for the UK clinical pharmacology workforce.

I have also recently been appointed as the FPM’s Director of Human Pharmacology, building on my input into the development of the new FPM PMST speciality training curriculum and assessment. This curriculum will support the training of future pharmaceutical physicians and equip them with the generic and specialty capabilities to meet the present and future needs and challenges of healthcare.

New approach adding value

Facilitating this type of flexible learning is a challenge but there are benefits for my team and the wider UK life sciences environment. Most obviously, investing in a specialised workforce is crucial to ensuring that my organisation can conduct the most advanced trials. As an example, last year we conducted a trial for Intellia Therapeutics focused on using gene editing CRISPR technology to reduce the impact of ATTR – a rare and potentially fatal disease.

Conducting gene-editing treatment studies such as this, directly in the patient population, is an extremely specialised skill but will increasingly become more in demand as our knowledge of genomics increases. It was only possible because of the continuous training that we facilitate and by instilling the ability of our clinical researchers to flexibly apply their learning to adapt to different circumstances. Delivery of a ground breaking phase Ib study safely and effectively provides practical experience for our more junior practitioners – who in several years will be able to lead on similar studies by themselves.

This model of workforce development means that organisations such as mine retain and develop the skills that bring us a competitive advantage in delivering groundbreaking early phase clinical research. However, it also improves the wider sector as our trainees may move into academia, medical careers, focus on bringing drugs to developing countries to help those most in need, or even set up their own businesses via new clinical research units, as I did with Dr Jorg Taubel twenty years ago.

Not standing still

The beauty of science is that it evolves, and the processes and norms are subverted by newer and better ways of working. This means that the workforce is also always changing, and the training must do so too. In the years ahead, clinical researchers will need access to a more diverse skill set, greater ability to manage and analyse data, and more experience with the latest scientific tools.

The training and CPD environment must reflect these changes, building curricula that are tailored for the future ways of working in the sector. Competition on the global stage is fierce in clinical research and this is a positive if it goes hand in hand with collaboration – which is what moves science forward. I am confident that the support and training offered to medical practitioners in the UK will ensure that we remain at the forefront of clinical research for the benefit of patients.

Ulrike Lorch is medical director at Richmond Pharmacology