Putting patients at the heart of early-phase clinical trials

  • 15 October 2021
  • Jules Payne, CEO of Heart UK – The Cholesterol Charity

The UK is an important player globally in therapeutic innovation.  Science is amazing and moves forward at an incredible rate.  Scientists love innovating to improve health outcomes for patients, and patients want these positive health outcomes in order to live a longer healthier life.  But there is much to be done to morph this into a truly valuable partnership. 

All innovations are developed with the patient in mind, however the individual patient should be placed at the centre of any innovation.  In fact, the phrase ‘nothing about us, without us’ should be adopted across all therapeutic areas.

The UK Government recently published the implementation plan for its vision for the future of clinical research in the UK: ‘Saving and Improving Lives: The Future of the UK clinical research delivery.’  This sets out an ambitious action plan that aims to bring together all four nations of the UK and their health and care systems to deliver robust and safe world-leading clinical trials.  The action plan covers proposals to introduce a digital approach, deliver efficiencies, remove red tape and ensure inclusivity.  

This is a good plan and we would like to see the patient involved in any innovation from the very outset of any trial design.  Patients have their real-life experience of living with a condition and understand how it affects their health, lives and families.  As a result, the contribution patients can make to research is significant. Patients can help other patients to get involved, to want to take part in a trial and to stay involved once they enrol.  The action plan appears to deliver a system that will be more fitting to empower patients to take part.  Only patientsthe real impact of a new therapeutic solution.  The scientists clearly understand how a new innovation may work in the body, but from start to finish this should be a collaboration between the two in order to achieve the end goal of improved patient health outcomes.

Currently, clinical trials sometimes feel as though they are untouchable for patients, but why?  It often appears to patients there is mystery around the whole subject.  There is very much a need for education about how clinical trials work, the various stages and the timeframes of development.  We all live in an instant society, but clinical trials explained clearly will start to unveil the cloudiness of that mystery and bring an in-depth understanding to patients of the importance of the whole development process.  There is a need for patients to understand how trials work, the reasons for each stage and also why the timings are so important.  As all these areas become clearer, more and more patients will want to get involved and make a contribution to a healthier society. 

Medical jargon is often used when writing trial designs.  Thought must be put in to ensure everyone involved understands the words written and what the trial is looking to achieve.  I would like to think the new system will embrace this.  Of course, it is accepted that medical terms will be necessary throughout the designs, but they must always be explained in a glossary.  There should be full clarity about what each stage is looking to achieve and what is expected of the patient at every point.  Once patients better understand this, they are more likely to have a sense of contribution and desire to be, and stay, involved.  Ultimately patients could become champions, rather than feeling like guinea pigs.  This should lead to much improved recruitment and retention for clinical trials.

Involving patient organisations is essential in this whole process.  HEART UK, as well as other organisations representing the patient voice in many different guises, are well versed in writing patient materials.  The contribution of patient organisations would be significant with making a smooth transition.  They could assist with moving the position of almost a total lack of understanding to an in-depth knowledge of an incredibly important area for the future health of society.   Whilst patient groups are not specifically mentioned, I certainly hope they are part of the action plan.    

Patients are at the heart of clinical research, and their involvement in early and late phase clinical trials is essential to the development of innovative and potentially life-saving treatments. Therefore, the Government must ensure that it delivers on its commitment to empower patients to become more aware of the opportunities available to participate in clinical research and support them should they choose to take part. I look forward to working alongside the clinical research community and with HEART UK’s network of patient groups to make this happen.  

Jules Payne is CEO of HEART UK – The Cholesterol Charity, which is the only UK charity dedicated to preventing early disease and deaths from cholesterol and other blood fat conditions.

This blog is also supported by:

  • Heart Rhythm Alliance
  • Blood Pressure UK
  • Cardiomyopathy – the heart muscle charity