Derek C Stewart OBE, patient advocate Hon Professor National University of Ireland Galway, co-chair of the #MakeItPublic Campaign Group and former member of the Research Transparency Strategy Group blogs on the engagement and involvement of the public and patients in clinical trials.
Illuminating the way
Involving patients, carers and the public in clinical research is the key to making sure research is successful, accepted and understood by those it is for. But this is nothing without transparency - it is about being able to find out what studies are taking place and what happened as well as being more open and see through.
For many years patient and public involvement (PPI) has helped inform, shape and influence research to improve the questions, design and quality of trial protocols. Now, our involvement can help illuminate the way in which the study is reported back to those who participated.
A time of change
This is taking place because of the growing expectations and demand amongst patient communities that those who take part in research should hear about the results and rightly so.
Health Research Authority (HRA) is leading the charge on research transparency on behalf of the research community. Working with patient/public input throughout and collaboratively with others including the Association of British Pharmaceutical Industry (ABPI) and the Association of Medical Research Charities (AMRC).
Informing research participants is long overdue!
Reasons to get involved
Through its #MakeItPublic campaign and its public involvement work the HRA is asking researchers to actively partner with patients, carers and the public. There is potential impact from such involvement to make further improvements to the value of research and transparency in research.
We can help ensure that the language in the summary of the findings is clear and understandable. We can suggest how to phrase certain sentences to avoid misinterpretation. We can advise on the format and layout of the information. We can offer opinions and help with practical decisions. We can put forward ideas of how to communicate the summary to specific patient communities and networks. We can counsel of the importance of data use for further research.
We can point out to researchers that they have a responsibility to register their research and to inform those people who choose to participate about the outcome of the study.
These are all examples of why researchers need to involve the most appropriate patients as early as possible because giving proper consideration to informing participants is best done in the design stage. They are all efforts that engender trust.
Involving patients and the public early means seeing participation in a study as a relationship and thinking about how to communicate throughout the study. It gives rise to the consideration of giving regular updates, websites, apps and better use of digital technology.
The COVID-19 Zoe Symptom App is a good example of how to keep people informed, maintaining contact whilst gathering data.
We may also wish, at times, to remind researchers that much of this is public money. We may occasionally need to remark that failure to do so will have consequences for gaining approvals and funding in the future.
For those of us who are patient advocates for involvement in research, it is incumbent upon us to understand these key issues, policies and guidance to encourage others and demonstrate leadership. It is in this way that we build our knowledge, understanding and develop our critical thinking skills.
Transparency is about being willing to engage and actively involve those who are most likely to benefit from the study. It is about seeing research through from beginning to end - though in reality it tends almost inevitably to raise further questions - but at least we will be able to know what happened.
Derek Stewart OBE is a former teacher who was treated for throat cancer in 1995. He is a passionate advocate for patient and public involvement of all aspects of health and care research. In this capacity he has been involved with many research projects and chaired groups and boards.
This blog is part of our series for International Clinical Trials Day, looking at transparency and the involvement of the public in clinical trials.
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