THEY are one of the most important ways researchers have in testing whether pioneering treatments or life-changing drugs will actually work.

In Southampton alone last year more than 440 clinical trials were undertaken with each one having the potential to transform lives.

Research involving tens of thousands of people who use health services in the city has led to a number of advances in medicine and healthcare in areas including cancer, antenatal and obesity.

But recruiting people to clinical trials is becoming increasingly difficult with fewer and fewer people signing up to take part, and surprisingly little research carried out as to why.

Across the country, research has shown that recruitment rates are down. In a study of 122 clinical trials spanning 18 clinical areas, only 31 per cent had reached their target number.

Now, in groundbreaking new study published in the Social Science and Medicine journal, researchers from Southampton have analysed the reasons behind the lack of participation in a bid to improve recruitment and maintain clinical trials as a key part of advancing medical knowledge and patient care.

Almost 300 pregnant women took part in the research conducted by Dr Sofia Strömmer which was aimed at identifying the underlying reasons for women’s refusal to participate in a pregnancy trial and to identify ways of increasing recruitment.

“We wanted to understand what the reluctance to take part in trials was about, so that we could address it. Only when research is tested in this way on a cross section of society, can we get the best possible research to inform us,” explained Dr Strömmer.

She and her team interviewed 296 women who had declined to take part in trials and from that survey concluded that there was a fundamental lack of trust in those who chose not to take part.

Dr Strömmer explained: “Despite what they were being told about the research, women who declined the trial worried that they or their child could be at risk and felt that coming in for extra appointments was impossible to fit into their lives. Women who agreed to take part believed that the research would cause no harm and found ways around fitting it in to their busy lives.”

As a result of her work, Dr Strömmer came up with a number of suggestions as to how the trust issue could be overcome. One of the recommendations was to set up an online review-style platform for participants to ‘rate their clinical trial experience’ in an effort to improve participation rates.

“By reading reviews and information on this review platform, it would be coming from an independent source rather than a clinician or researcher,” added Dr Strömmer, a psychologist based at the NIHR Southampton Biomedical Research Centre at the University of Southampton MRC Lifecourse Epidemiology Unit based at University Hospital Southampton.

Building trust was also behind the recommendation to invest time in open and honest discussions of the risks and benefits of the clinical trial, and so build up more of a relationship between staff and potential participants.

Dr Mary Barker, associate professor who was also involved in the study, said: “We think that these strategies could be implemented relatively easily into the pregnancy trials protocols and make a real difference in allowing women to feel heard and supported and therefore raise the likelihood of participation in clinical trials.”

Case study:

It didn’t take first-time mum Rachael Wilton very long to make up her mind to take part in a clinical trial when she was first approached.

Newly pregnant, Rachael an operations manager from Marchwood, was keen to find out more about the SPRING trial run by the University of Southampton’s MRC Lifecourse Epidemiology Unit based at University Hospital Southampton, when she was first approached at a midwife appointment.

Following her 12-week scan she was told about SPRING which brings together the interventions in a previous vitamin D supplementation trial and a programme called Healthy Conversation Skills to improve health behaviours in mothers and the children as well as the body composition of the children.

During her pregnancy Rachael was asked to complete some lifestyle questionnaires and undergo additional scans.

Rachael said she and husband Jonathan were keen to take part in the trial. “We wanted to be a part of the research project, it sounded like a really interesting piece of research. There were also some extra benefits too like the extra scans and parking for free so it seemed like a really easy decision to make.”

When asked why she felt it was important to take part in the trial, Rachael, who gave birth to Imogen four months ago, said: “If everyone can do a small part it really does make a difference. The research could lead to developments that could help your family or someone else’s in the future, hopefully it will make a big difference in the end.”

To find out more about clinical research in Southampton visit http://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Home.aspx