The findings are from a new 'impact report' by the Tufts Center for the Study of Drug Development (CSDD), which set out to assess how CRA workload has been affected by the global expansion of the clinical trials sector over the last 15 years.
According to the research – which involved nearly 4,000 CRA respondents at biopharma companies and contract research organisations (CRO) – CRAs put in an average of 165 hours a month with those in the US working 178 hours and those in Europe doing 143.
Of this CRA’s spend 41 per cent of their time in on-site monitoring tasks with off-site monitoring, admin and training taking up, respectively, 22 per cent, 13 per cent and 5 per cent of their remaining time.
Tufts senior project manager Mary Jo Lamberti told Outsouyrcing-pharma.com the findings have implications for CRAs and their employers, explaining that: “The first step in more efficiently managing CRA time is to gather baseline data so that CRA managers are making informed decisions. “
This is approach has been adopted by regulators according to Dr Lamberti who added that “[The US] FDA and EMA are already looking at ways of reducing CRA work burden. The Tufts CSDD study can help inform these discussions.
Time, travel
The research also showed that travel to and from trial sites takes up around 20 per cent of the average CRA’s time each month, with those in the US spending the longest time on the road followed by their European counterparts and then those in Canada and Asia.
This realisation that CRAs spend so much of the working lives travelling has significant implications for time management, particularly given the continued global expansion of the clinical research sector.
Lamberti suggested that: “Use of risk-based strategies or use of specific analytic tools would enable CRAs to discover incomplete data before visiting a site and would increase their efficiency and time on site. These approaches would assist the monitoring of productivity although not necessarily eliminate visits completely.”
Work-life balance
The Tufts team also asked respondents how happy they are in their jobs with a majority - 53 per cent - rating their quality of life as good or excellent.
CRAs in Canada are happiest with their jobs according to the survey, closely followed by those-based in Eastern Europe some 60 per cent of whom rated their quality as good or excellent.
In contrast, only 44 per cent of respondents in Latin America rated their employment-related quality of life as excellent or good, just below those in Asia-Pacific and Western Europe.
This finding was also reflected in the average length of time CRAs expect to stay in a particular monitoring role – with those in Western Europe and Asia changing jobs every 12 to 18 months compared with those in North America who anticipate staying in their current job for at least five years.