Significant new research from Warwick Business School and Queen Mary, University of London, warns that delays and variability in the approvals process for clinical research could be causing pharmaceutical companies to look outside the UK and risks the country losing some of its most experienced researchers.
The two year study focused on identifying the key social, organisational and managerial factors that influence clinical research projects in the UK. In the first study of its kind, the researchers carried out a national survey in which they interviewed key stakeholders and surveyed 247 clinical research projects about the challenges of managing clinical research. The study found that although patient recruitment was and remains a major challenge, retaining the project team was seen as critical to the ongoing success of clinical research and that this was becoming increasingly difficult.
Additionally the research found that retaining the research team throughout the project was significantly hampered by aspects of the approval process; projects which had been approved by the regulatory bodies often then encountered difficulty in obtaining approval from the hospital Trusts and that there was huge variation in both the time and requirements needed to gain approval from these Trusts.
Professor Jacky Swan of Warwick Business School commented, "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 and that does have long term and significant implications for high quality research in the UK and also for the retention of skilled researchers."
Additionally, Professor Swan stressed that the inconsistencies and lengthiness of the approvals processes has a detrimental effect on the completion rates of non- commercial organisations.
"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." she added.
"Far more policy attention is needed to address these problems; especially around the skills shortages that are emerging 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." added Maxine Robertson, Professor of Innovation and Organisation at Queen Mary, University of London.
The majority of the 247 research projects in this study were projects which had been carried out in the last two years. The length of time each took to receive approval included the time for preparation of submissions and not simply the time from submission to approval.
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