World Cancer Day: How the HRA facilitates and regulates cancer research

Each year our Research Ethics Committees (RECs) review and approve around 6,000 studies, many related to cancer. To mark World Cancer Day, we’ve been looking at some of the work the Health Research Authority does to facilitate and regulate good cancer research.

The importance of good participant involvement in cancer research

We have been working with patient advocate Richard Stephens – a former cancer patient with over 20 years’ experience working with researchers and funders to help improve their study design. Richard has helped to train HRA staff and Research Ethics Committees (RECs) about the importance of good public involvement. He recently co-led a workshop on improving participant-facing information in commercially-funded studies.

Patients should not only be at the centre of trial design, we should be present throughout the whole research process. In the UK we are ahead of any other country in the world, but we still have lots of gaps to fill. Fortunately, we have more and more patients volunteering to help fill them, and a growing number of training programmes and courses to support them.

Richard Stephens, Patient Advocate

Immunotherapy

Our non-executive director Professor Andrew George is a cancer researcher. He’s worked in the field of immunotherapy throughout his career. Andrew says people can have confidence that research is done ethically, with patients at the centre of the process, because of the work of the HRA.

It is sometimes said that new technologies take twice as long as anyone estimates to become useful – but that their impact is double what anyone predicts. That is certainly the case for immunotherapy – when I was a young researcher in the field I believed it would be something that would be in routine use in a few years. I was wrong! But I was also wrong in underestimating the difference that immunotherapy would make to so many patients. This benefit is the result of decades of research, both in the laboratory and the clinic.

“The public can have confidence that the research is done ethically, in a way that puts the needs of the patient at the centre of the process, because of the work of the HRA and the research ethics service that it provides.

Professor Andrew George, HRA non-executive director and cancer researcher

Complex Innovative Design (CID) trials

We also recently worked with the Experimental Cancer Medicine Centre, Independent Cancer Patient Voices, Cancer ResearchUK and others to develop new recommendations for researchers running Complex Innovative Design (CID) trials.

CID trials are increasingly being used as an evaluation method by researchers, instead of traditional drug development pathways involving clinical trials from phases 1 to 4. The CID approach enables researchers to carry out more complex trials that address multiple clinical questions at once. For example, a drug can be simultaneously evaluated for safety and efficacy with different cancer types, which can change as the trial progresses, accelerating the traditional route to drug licencing. However, they can be challenging to conduct and there are currently no practical guidelines for teams that fund, design and conduct these trials in Europe.

We hope the 10 recommendations which came out of this work, published in the British Journal of Cancer, will help facilitate efficient, life-changing clinical research.

HRA Engagement Manager Will Navaie took part in the working group and has blogged about his experience.
You can also read about the role Research Ethics Committee Chair Stephanie Ellis played in developing the recommendations.

These important recommendations now bring clarity for researchers in terms of how they should be running high quality CID trials. They are a statement of intent for the UK as a global leader in conducting efficient and life-changing clinical research.

Juliet Tizzard, Director of Policy at the Health Research Authority