Teresa Allen is the chief executive of the UK’s Health Research Authority (HRA), an executive non-departmental public body of the UK’s Department of Health. The HRA which works with other UK organizations to regulate different aspects of health and social care research. This involves making sure that research is ethically reviewed and approved and promoting transparency in research. HRA has oversight of a range of committees and services including the provision of independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects. Teresa nears the end of her tenure with the HRA and reflects on her fulfilling career in clinical research.
- How did you get into the clinical research and industry and what career path did you take?
My career started as a Biomedical Scientist in the microbiology laboratories at the John Radcliffe hospital in Oxford, UK. There we had a very active research team and close links with Oxford University and local Public Health teams, which created an opportunity to get involved in clinical research. As I advanced my career, I transferred across to the UK’s Blood Service running the transfusion microbiology service before moving into the commercial sector where I worked as a Director for two diagnostic companies before moving to the NHS Blood & Transplant (NHSBT). Before I joined the Health Research Authority (HRA), I sat on the NHSBT Research Strategy Board where I had the challenging task of prioritizing which research projects we should prioritize and fund. I’ve been fortunate to move around the health and care system, however clinical research has always been an important part of the services I have worked in, striving to offer patients evidence-based changes to existing services or improved treatments or diagnostic tests.
- What have been the biggest challenges and successes of your career and why?
In one of my last positions at the NHS Blood & Transplant, I was responsible for the stocks of all blood components and forecasting the demand to ensure that we always had the right product available and distributed to the correct patient. This was an incredibly challenging role; we had to consider all the many blood characteristics to match multiple blood components, alongside different shelf lives and storage conditions as well as consideration to a supply chain which is dependent on donor and hospital behavior, the weather, seasonal infections and a whole range of other variables. Ultimately my challenge was to make sure we maintained just enough stocks to avoid wastage, which had a huge responsibility with it. I achieved this by leading the development of a number of new blood demand forecasting tools and working closely with hospital transfusion teams across the country to implement electronic ordering and vendor managed inventory so that we could see the whole supply chain. Within this role I led a number of teams who did a huge amount of work with UK hospitals enabling us to initiate our own research, working with leading UK Universities including Brunel, Warwick and Cranfield. This work allowed us to develop world class systems for managing the blood supply chain. I am really proud of the advances we made under my leadership which allowed us to be there for the patients who needed us.
- How has the Health Research Authority changed during your time as CEO?
So much has changed since I joined the HRA that we could fill a few pages with achievements but the things that are of most relevance are the changes that were designed to improve the applicant experience. The Industrial Life Sciences Strategy has provided a cohesive common vision for change and we have focused a lot of effort on clinical trials, reducing the end-to-end approval time, proportionality and exchanging data with others, thus expediting the initiation of approved trials in the UK.
We started a pilot project with the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health Research (NIHR) to see if we could work together to improve the timelines for clinical trials. This culminated in the Combined Ways of Working pilot which has demonstrated that by exchanging information across our IT platforms and processing applications in parallel, we can cut timelines significantly without compromising on quality. Researchers had consistently told us that the Integrated Research Application System (IRAS) was too complex and not user friendly so in 2018 we started a major software development program to transform the way researchers submit their applications. We are still on the development journey of this but applicants will start to experience the really transformative change over the next couple of years when we aim to complete the modules which process 80% of research applications that are not clinical trials.
- 2020 has been an unusual and challenging year. What have you learnt and what would you do differently, given the benefit of hindsight?
All of the changes that we have made in the HRA over the last four years allowed us to almost seamlessly change our service operating model when the UK Prime Minister placed us into lockdown in March 2020. Last year we had already piloted some virtual research ethics committees, tested out new technology options to support virtual working and worked with a number of leading UK Universities to reduce the number of student applications which we were reviewing. As such, we already knew it was possible to make the shift to a virtual working model even though we had not tested this at scale. We had also already developed a fast-track model for pandemic flu which was rapidly adapted to process urgent public health COVID-19 applications. The first of these applications arrived within a few days of us switching to this fast-track service and as a result of the whole research system coming together to implement a triage system, we were able to rapidly pivot our staff and volunteers onto this new COVID-19 advisory and fast-track service. To ensure our staff were not overwhelmed we also took the decision not to accept non PhD student research applications in the short-term, which alleviated a lot of potential pressure.
By being involved in the cross-agency decision making group set up by the UK’s Department of Health and Social Care (DHSC) I knew it was essential to respond to the pandemic in an informed way. It will not surprise anyone to hear me say that triaging research and prioritizing one type of research over another is challenging for the research community; but it was essential at a time when the whole system was severely stretched. The response to the pandemic also reminded me how having a crisis can bring out the best in people. We were all aligned around a common purpose with a sense of real urgency.
As the chief executive, I knew I had to be very clear and directive to ensure that everyone understood what was expected of them, but the team at the HRA and our all our volunteers have been fantastic working extremely long hours and getting on with the job.
If I had a chance to go back in time, I would have spent more time engaging with our volunteers during the last few months. Whilst I know we were talking to them consistently, our systems for collecting their feedback were not as good as we needed them to be and we have only recently managed to start talking to them about their experiences. We take these insights very seriously and hope to use them to inform our evolved business model further
- What do you think are the greatest challenges and opportunities for commercial clinical research in the NHS?
The major challenges that I hear about when I talk to a number of my CEO colleagues in the provider sector is the ripple effect that COVID-19 has created. The service provision model that was in place at the start of March has fundamentally changed. Social distancing has taken up space, many patients are being seen via teleconferencing or video conferencing and people are interacting in a different way. We are operating in a new world which, although it can be challenging, it does present new opportunities, we just need to adapt to them.
- Why is GCSA important and how do you think GCSA will help
GCSA has come at an opportune time with an important role to play as it aspires to bring more commercial research to the UK. I believe the GCSA has the potential to bring clarity as to what separates one clinical research site from another; this differentiation and the reassurance of quality it offers will help speed up the roll-out and delivery of clinical research, without compromising on quality. I see it working as a trademark for quality, like the ISO 9000, it is an instantly recognizable badge with a clear benchmark for sites to aspire to and strive for.
As things are evolving in clinical research, speed is of the essence as we’ve seen this year, and this exemplifies the need for this ‘quality passport’, enabling things to work quicker. Potentially, this could and should serve to help make the UK a more attractive place to do more commercial clinical research and to increase opportunities to attract more patients.
- What career advice would you give to your younger self?
By nature, I’m a worrier and so I would have told myself not to worry so much. My career followed the natural progression and I have no regrets, I’ve had a very full and varied career, however I do think I could have been bolder earlier in my career if I had been less worried and cautious. I had the skillset and knew what I was doing; for me, its was a secondment which arose through the Department of Health’s leadership talent program that helped me make the move to the HRA which I’m so grateful for. I’d had a wonderful experience working at the NHSBT, moving through various roles and gaining a breadth of experience, but this secondment really allowed me to experience a move I might not have gone for. As such, I would definitely encourage people to take a secondment opportunity if it arises, you never know where you might end up.
But ultimately, I have been fortunate enough to have had a lot of wonderful jobs and I’ve always enjoyed my work, and that counts for a lot!
- What achievement are you most proud of in your career?
As I’ve mentioned I’ve faced a number of challenges in my career and overcoming those are huge achievements in their own right. Looking collectively at my career, right now I would probably have to say the advancements we have made within the HRA. We have implemented a number of changes during my time with the HRA with the sole purpose of improving the end-to-end Approvals Service. One of key methods in doing this was using the skill-set of the HRA staff; they’re the ones who know the service better than anyone else and so their insights were invaluable. We’ve implemented technology to increase efficiencies, to create a better working model that effectively serves the research community.
This came to fruition this year in a way we had not anticipated with the pandemic, but the timeliness is remarkable. We were able to pivot very quickly to a remote-based working model which was able to approve trials in an exceptionally short timeframe. We capitalized on how we worked to improve that at a time we needed it most.
- What are your hopes and aspirations for 2021?
For the HRA I think there are a lot of opportunities that will come out from the COVID work and a number of initiatives including a new Fast track feasibility study supported by an upfront Advisory Service. The HRA’s ultimate aim is making the experience for research applications as easy as possible with the single vision of making the UK a great place to deliver research; I believe we’re well on our way to achieving this and will further extend this in 2021.
Personally, I’m planning on retiring and taking some time for myself. The process for my replacement is well underway with the appointment expected imminently. I will oversee the transition and then I plan on undertaking an Advanced Diploma in Archaeology, a passion of mine, but I’m sure I will also keep some involvement in the health and research world as this is my main passion and helps to save or improve people’s lives across the globe.