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Being involved with Trials Methodology

Being involved with Trials Methodology – some reflections from Derek Stewart – PPI Contributor and HRB-TMRN Executive Management Committee member.

Inviting patients and the public into the world of doing research into the methods that are used in health studies such as trials – i.e. Trials Methodology – may seem too daunting and too difficult, for all concerned. Hopefully, this blog post will inspire your curiosity.

This animation is a good starting place for those who might like to know more:


A more formal definition and explanation is offered by Catrin Tudor Smith, et al, that Trials Methodology Research is…

‘Research into the methods used in the design, conduct, analysis and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust.’

My own participation with Trials Methodology was through Patient, Public Involvement (PPI) and came with the Priority Studies – initially an opportunity to find out what we don’t know about recruiting people to trials. It led to my first attempt to describe the experience – What is Trials Methodology.

It was an illuminating and positive experience. I came to realise that this involvement with trials methodology has the potential to improve many, many different studies.

Patient, Public Involvement brings a pragmatism, external perspective and opinions on the uncertainties that methodologists wrestle with as part of the decision making within their work. It is precisely in this space that the contributions can be so valuable. Equally for those us who get involved it provides an opportunity to learn more about health research methods and helps us ask better questions with other projects.

The last few years have seen more research bringing patients and the public together with trialists across Ireland…

There is also the Workshop Report into PPI with Trials Methodology that can be found here. The HRB-TMRN is part of the UK Trials Methodology Partnership (TMRP) who have a useful guide.

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