Conducted in December, 2010, the study focused on three-year trends and canvassed the opinion of more than 500 clinical research site investigators and coordinators from large organisations such as Johns Hopkins University, in Baltimore, US, and the not-for-profit medical group, Mayo Clinic. Researchers also spoke to a number of hospitals, as well as multi-speciality and private practices.
According to CRST's findings, “key challenges” exist in areas such as subject recruitment and retention, and the tracking and reporting of data. However, the company say problems at trial sites are not confined to patient and data management.
The survey found that 66 per cent of large organisations had reported and increase in the number of trials they were being asked to conduct. A further 60 per cent said they had difficulty in managing trial profitability, whilst 40 per cent claimed it had become more difficult to recruit and retain trial subjects.
Perhaps most surprising, however, is the feedback CRST received about training.
Though 50 per cent of those surveyed claimed to have experienced an increase in training provision, lack of training “remains a major issue,” with a staggering 80 per cent of nurses requesting more training in quality assurance, and more than 60 per cent claiming to need more training in the finer points of FDA auditing.
Low web awareness
In addition to training needs, the survey sought to explore the way clinical trial sites use the web for work information. Again, the results were surprising.
According to CRST, and in spite of increased specialised web content about the “clinical site world,” web awareness and usage were both relatively low.
The survey found the primary information tool to be popular internet search engines such as Google, with on average less than 40 per cent of nurses, and 20 per cent of doctors making use of major specialised sites.
Only two sites, the National Institute of Health's web portal and the Clinical Trial Network, boasted more than 50 per cent awareness amongst all site professionals.
In response to survey, Lester Levine, president of CRST said: “Our findings suggest clinical research sites should increase training on financial management, site quality assurance, subject recruitment and retention, and FDA inspections.
Levine also noted that many trial sites fail to manage “the convergence of increased and more complex trials,” and would benefit from recruiting new staff whilst retaining those with experience.
He also suggested companies should more actively seek to pool resources by “reaching out on the web for new and improved ways of working, from both formal information sites and clinical research site communities.”