Published: 12 August 2020
Jeremy Taylor, NIHR Director for Public Voice, NIHR Centre for Engagement and Dissemination, discusses how COVID-19 has brought clinical trials to the forefront and outlines recent work done by the Centre on improving the experience of those participating in clinical trials.
Suddenly everyone is talking about clinical trials. COVID-19 has raised their public profile and resulted in new platforms for public engagement - for example the new Vaccine Research Registry that allows people to register their interest in COVID-19 vaccines trials.
The pandemic has heated up a pre-existing debate about clinical trials. How does post-Brexit Britain carve out a pre-eminent position as a location for trials? How do we make best use of digital technologies, patient data and advanced study design - as exemplified by the RECOVERY trial? How do we minimise bureaucratic and other obstacles that can hamper and slow the pace of research? How do we ensure that on both scientific and ethical grounds, the volunteers who participate in trials are sufficiently representative of the broader population?
Lots of people are looking at these issues. For example, The Wellcome Trust’s Good Clinical Trials Collaborative is seeking new international guidelines. NIHR has a new INCLUDE website with guidance on improving the inclusion of under-served groups in clinical research. NIHR's Be Part of Research website enables patients and the public to find out about health and care research taking place in the UK.
My own NIHR Centre for Engagement and Dissemination has just delivered advice to the Department of Health and Social Care. Our specific focus: what matters to patients and trial participants? We recently held an online workshop, jointly with NIHR colleagues, the Centre for BME Health and the Association of Medical Research Charities. It was a diverse group of more than 35 attendees, mostly people who had taken part in clinical trials or were in other ways contributing to research as patients and citizens. In parallel, we did a rapid trawl of the research literature and NIHR Research Participant Experience survey evidence.
We pulled all this intelligence together into a short advice note. Here is a summary of our recommendations:
- Many patients and members of the public are unaware of opportunities to take part in trials. Now is an opportune time to raise awareness. Enrolling people into trials requires good communication. People value clear and understandable information about the trial’s purpose and conduct, the risks and benefits, and their role as a participant. Information needs to be appropriate and proportionate. Jargon and lengthy,complicated patient information sheets are not welcome.
- Taking part in trials imposes physical, practical and emotional burdens on participants (and, often, their families), especially if they are also patients. Good trial design is vital for minimising this. Not all researchers think hard enough about this, meaning participants can be subjected to unnecessary tests, surveys, procedures and clinic visits. Good design minimises the invasiveness of procedures, for example, using previous blood tests rather than new biopsies. Good trial design is also key to successfully recruiting participants and enabling them to stay in the trial.
- Meaningful patient and public involvement is an integral feature of good trial design and there should be a stronger emphasis on this happening at the earliest stages.
- There are too few participants from poorer, black and minority ethnic communities - and from many other under-served groups. Targeted, culturally sensitive approaches are needed for different communities. Research teams need to build relationships with relevant communities from the outset, and as part of the overall approach to patient and public involvement.
- Being excluded from a trial can be discriminatory and hurtful. Researchers must avoid drawing exclusion criteria too broadly and need a robust scientific justification for them. Excluding volunteers on the basis of the criteria needs sensitive handling and communication.
- Participants are most likely to have a positive experience in a relationship of trust with the research team. Good quality information, communication and person-centred care, support and attention are key ingredients throughout the trial.
- Participants must be informed of trial results. Failure to do so is in direct contradiction of current policy, most recently stated in the Health Research Authority’s updated position on research transparency, 'Make It Public'. It is a discourtesy, if not an abuse of people’s goodwill, and is likely to deter them from further participation in trials. It is also potentially harmful to people’s mental and physical health. Participants need to know what contribution they have made and the implications for their personal health (that may require regular updates during the trial). And they need to be thanked.
- There is an understandable desire to remove unnecessary administrative, capacity and governance hurdles to the set up and conduct of trials, but this must not compromise the safety, quality and robustness of the research - or the patient and public involvement in the research.
- In our workshop, attendees were optimistic about the opportunities to improve the design and conduct of clinical trials. Such changes should be developed in partnership with patients, participants and the public and be informed by what matters to them, with a particular focus on those who are less heard.
Jeremy Taylor, NIHR Director for Public Voice, NIHR Centre for Engagement and Dissemination
Meanwhile, you can visit the Be Part of Research website to find out about the range of opportunities available.