Today’s blog post comes to us from Nathan Waller, Medrio’s managing Director of EMEA and a former Director of Business Development at a global CRO.
For CROs, clinical research can at times feel like walking a tightrope. If you can keep your balance, success is waiting for you on the other side of the chasm, in the form of satisfied sponsors whose timeline demands you’ve met and who are now inclined to favor you over competitors for future studies. But below you lies peril: patient dropout, unforeseen protocol amendments, long and intensive EDC setup processes, and other threats. All of these threaten significant study delays that can be hard to recover from. And prominent among them is employee turnover at your organization – particularly among clinical research associates (CRAs).
The prevalence of this issue is not to be underestimated. This year, Worldwide Clinical Trials put the CRA turnover rate within the CRO industry at 23% in Europe. In the US, it was even higher, at 25%. Industry players have floated several theories to account for this trend, from regular underpayment of CRAs to the fact that the position is often seen as a stepping stone to other roles within clinical research.
But whatever the reasons for CRA attrition, its impact is real and potentially very serious. A central component of clinical trial monitoring, CRAs perform an essential function at CROs, and their sudden departure can cause serious disruption in an organization’s ability to validate clinical data in a timely fashion. It can also seriously overburden the CRAs that remain – which poses additional threats. Recently I was talking to a friend at an EU HQ’ed top 50 Global Pharma company. Running a major global clinical trial as Global Project Director, he said in April he planned 48 initiation visits for May. Mid-May, he was estimating 25. By the end of the month, he’d completed only 6. His reason? Over-burdened CRAs.
CRA turnover, then, poses a wide array of dangers, from decreased productivity, to extended timelines, to increased expenditure and, ultimately, to unhappy sponsors.
Clinical research associates and the eSource revolution
It’s difficult to predict how long it will be until the industry figures out how to rein in attrition among clinical research associates. In the meantime, though, CROs today are conducting studies in the technological golden age of clinical research, and are exploring new ways to soften the impact of turnover at their organizations.
We posted recently on how eSource can position CROs to edge out competitors, win more sponsor business, and take full advantage of increasing sponsor-to-CRO outsourcing. To this list of reasons eSource may be more beneficial to CROs than conventional wisdom suggests, we can now add its ability to minimize the disruption caused when a CRA leaves an organization mid-study. Every day, the eSource revolution is reducing organizations’ reliance on monitoring visits and source data verification – and thus serving as a crucial safety net in the event of unforeseen changes to monitoring staff.
This is not, of course, to say that eSource can completely nullify the impact of attrition. Clinical research associates do a lot more than just monitoring – from providing regulatory and protocol expertise to optimizing site performance and beyond – and when they leave, their absence is still felt. But with monitoring activities largely streamlined, CROs can continue to meet strict timelines and grow their portfolio while the industry addresses the issue of CRA turnover on a broad scale. It’s just one more reason eSource has gone from innovation to revolution.