Increasing difficulty retaining project teams is a key factor in the UK‘s declining status as a clinical research base, a new study suggests.
Moreover, it is obstacles and disparities in the approval process for clinical studies that are driving these researchers abroad, the two-year study by Warwick Business School (WBC) and Queen Mary, University of London concludes.
The researchers interviewed key stakeholders and surveyed 247 research projects to assess the challenges of managing clinical trials in the UK environment. Recent data pointed to a sharp drop in the number of Phase II to IV studies sited in the UK last year, despite well-publicised government efforts to streamline start-up procedures.
The WBC-Queen Mary team looked for the crucial social, organisational and managerial factors affecting clinical research projects in the UK. While patient recruitment remains a major hurdle, retaining the project team throughout is seen as critical to the ongoing success of research, the study finds.
This in turn is significantly hampered by aspects of the research approval process. For example, the researchers note, projects that have been approved by regulatory bodies often run into problems getting clearance from hospital trusts, while there is wide variation in the time and requirements for obtaining approval from these trusts.
“The problem is that, to commercial organisations, time is very important and although many are committed to carrying out clinical research in this country, many are finding it easier to do this research abroad,” commented Jacky Swan, Professor of Organisational Behaviour at Warwick Business School. This has “long-term and significant implications for high-quality research in the UK and also for the retention of skilled researchers”.
Protracted and inconsistent approval processes also have a detrimental effect on completion rates, Swan added. “There are three elements of approval: regulation, ethics, and research and development, and although there has been improvement in regulation and there have been efforts to streamline the R&D process, these are not happening quickly enough to have a positive impact.”
According to Maxine Robertson, Professor of Innovation and Organisation at Queen Mary, University of London, “far more” policy attention is needed to address these problems, particularly around emerging skills shortages and “aspects of the NHS culture which are making it very difficult to conduct the innovative, world-leading clinical research that the UK has always been known for”.
