CRAs spend less time on site, more time travelling
pharmafile | January 25, 2012 | News story | Research and Development | CRAs, Clinical Research Associates, Tufts, clinical trials
A new study of how clinical research associates (CRAs) spend their time has produced some interesting and surprising results.
The Tufts Center for the Study of Drug Development has conducted what it says is the first global benchmark of how CRAs spend their time.
CRAs are responsible for overseeing clinical studies conducted by research centres, and visit sites to ensure they are performing to the required standards.
The Tufts researchers estimate that there are 20,000- 23,000 CRAs supporting clinical research studies worldwide. They say their new study will give managers insights into how CRA effectiveness and efficiency can be improved.
According to Tufts CSDD, CRAs worldwide spent approximately 20% of their time travelling and devoted 41% of their time at clinical trial sites. Getz noted that prior to the study the research-based drug industry widely believed that CRAs spent 60% of their time on-site.
The study also found that CRA workload and time allocation varies widely from region to region – study monitors based in the US spend more time travelling and on-site than their counterparts elsewhere. European study monitors spend relatively more time performing off-site monitoring and administrative tasks.
Ken Getz is Tufts CSDD senior research fellow and assistant professor at Tufts University, and conducted the study.
“Over the past 15 years, demands on study monitors have intensified as clinical trial volume and complexity have increased. Yet, drug development managers haven’t had benchmarked global metrics to assess their CRA field force capacity and utilisation.”
CRAs ensure the safety of trial participants, the quality of clinical data, and the compliance by investigative site staff with the study protocol – making the CRA a vital role.
Getz concluded: “Knowing how much time CRAs spend on specific tasks gives managers and regulators a way to refine practices and policies aimed at enhancing CRA effectiveness and efficiency.”
The Tufts CSDD study, reported in the January/February Tufts CSDD Impact Report also found that:
• For Phase I studies, CRAs on average conduct 3.8 investigative site visits each month.
• For Phase II-III studies, CRAs on average conduct 7.9 investigative site visits each month.
• CRAs overall have an average of 6.3 years on the job and expect to remain in their position for another three years, with both metrics varying widely by region.
The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilisation.
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