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20^th May marks International Clinical Trials Day, a day dedicated to what is believed to be the first controlled clinical trial. In 1747, James Lind investigated the link between citrus fruits and scurvy using just 12 men on board the HMS Salisbury of Britain’s Royal Navy fleet.

Over the years, clinical research has advanced, and is vital in helping us cure illnesses and to improve our health. So, in recognition of the importance of clinical trials and public involvement, we interviewed Emmy Racine, University of Cork, Ireland, to talk about her research article, published on HRB Open Research, investigating patient and public involvement in clinical trials and how the results should be disseminated.

Why should patients and the public be involved in clinical research?

There are many ethical, moral and political arguments for involving patients and members of the public in clinical research. One such argument is that those affected by or paying for research should have a say in how it is done.

There are also pragmatic arguments being made for Patient and Public Involvement (PPI) based on the actual contribution that the public can make to research and its wider acceptability. There is some evidence that PPI can improve the quality, efficiency and impact of research but we really need stronger evidence on the impact of PPI before we can impart these claims.

Why do you think it is important to share trial results?

I think it is important to share trial results because trial participants invest a lot of time, effort and sometimes money (e.g. travel, parking, food expenses) in trials. Not only is it important to share trial results with participants but results should be shared in a way that is easy to read and understand.

A recent European Union Clinical Trial Regulation now requires trial sponsors to provide summary results of clinical trials to participants in a format understandable to lay people. This may sound like an easy thing to do but since the results are interpreted in the context of existing scientific evidence and debate, it is often difficult for trial researchers to present this information in a simple and straightforward way.

Were patients interested in receiving trial results?

Yes, I found that trial participants wanted to receive trial results. Many participants reported that they felt they had made an individual contribution to the trial in terms of their time and personal information and receiving the results of the trial would provide acknowledgement of this individual contribution. 

They also believed that their participation contributed to a collective benefit or greater good and they wanted to know the results so they could better understand what this collective benefit was. They wanted to know how the results of the trial would be put into practice by doctors and how it would affect other patients in the future.

How would they like the results to be presented to them? 

Participants were very clear that they wanted to receive the results in a way that was accessible and easy to understand. The majority said they would like to receive the results in a letter from the trial researchers posted to them directly. Although participants wanted an official statement of the results in a letter format, they also felt it was important to add a personal element to the letter.

They suggested offering participants a phone number that they could call if they wished to discuss any further issues or concerns with the study team. They were clear that the format, content and language of the results letter should to be easy to read and understand. All participants wanted the letter to be no longer than 2-3 pages and presented in a question and answer format.

They stressed that it was important that the information presented to them was informed by medical experts but easily understood by those without a scientific or medical background.

What next?

As part of my research, I developed a questionnaire to evaluate the impact of PPI on patient understanding of trial results. While levels of patient understanding were similar between the group that received the results letter developed by the PPI group (intervention) and the group that received the information developed by researchers at the lead trial site (control), we didn’t have enough people to confirm whether  the PPI letter made a difference. However, some additional analysis of the questionnaire suggested that it is a useful tool for measuring patient understanding of trial results.

As the questionnaire can be easily adapted for use in other trials, it would be great to see it being used by other trial methodology researchers to add to our results and generate further evidence on the impact of PPI on clinical trials.