Improving clinical trials focus of two new studies

Improving clinical trials focus of two new studies

The University of Aberdeen is celebrating International Clinical Trials Day with the announcement of funding for two new research studies, which aim to improve the experience for those who have participated in a trial and to lower dropout rates during trials.

Clinical trials are essential for testing new drugs and therapies and the input of doctors and patient participants are key for their continued success.

International Clinical Trials Day (May 20) celebrates the anniversary of the first randomised clinical trial in 1747 and is also important for recognising all those involved in making them a success.

The two new awards won by the University’s Health Services Research Unit (HSRU) have a combined value of around £350,000.

The prestigious Springboard award (around £100,000 over two years) from the Academy of Medical Sciences (AMS) is the first of its kind won by a University of Aberdeen researcher and one of the first studies in applied health science research to receive the award.

The study aims to identify the best ways of feeding back results to participants at the end of a clinical trial. Currently whilst government regulations require that trial participants must be offered feedback, there is no stipulation as to how that feedback should be presented and it is often presented in very dense and scientific language.

The study will look at what types of information participant’s value, the different ways the information can be presented to participants and the potential pros and cons associated with different methods.

 “There is a moral imperative to feedback results to those people who participated in a trial. People give up their time to help these studies and they have the right to receive simple, understandable information about what the study achieved in a way that is engaging for them," explains Dr Katie Gillies, a Senior Research Fellow, from the University of Aberdeen’s Health Services Research Unit, who will be leading the study.

Dr Gillies adds: “If participants have a positive experience with taking part in these trials, they may be more likely to feel empowered to take part again and to encourage others to get involved, so it makes complete sense to improve feedback methods.

“We will also be looking at how best to handle the presentation of negative information, for example when a treatment has been found not to work or found to be potentially harmful. There isn’t a lot of research that has explored the potential implications of feeding back results that may cause harm and distress to the recipients.”

Rosemary Humphreys, the Patient Research Partner involved in the study adds: “Even research projects which involve patients at all stages of their work often seem to forget about letting the trial participants know the results. 

“It’s really important to do so because without their co-operation there would be no clinical research. It’s their condition that’s being investigated so they have a right to know the results, having worked with the researchers, often for a long time. We need to communicate the results to them, in a format and language they can understand, thanking them and telling them why the trial was or was not successful and what the next steps will be.”

Another study, funded by the Scottish Government’s Chief Scientist Office (£250,000 over two years) begins in August and will examine why participants drop out of clinical trials and propose methods for improving participant retention.

Dr Gillies says: “Whilst there is a lot of research on how to recruit people into clinical trials, much less research has been carried out into how to keep people engaged in trials for the entire duration of the study.

“In this study we will speak to participants who have dropped out of trials in an attempt to build up a list of reasons why. From this, we want to develop strategies that are acceptable to participants to help keep people in trials.

“Both of these research studies will serve to improve how clinical trials are designed and conducted both nationally and internationally.”