The recently issued draft guidance on A Risk Based Approach to Monitoring of Clinical Investigations recommends that turnover at the clinical investigator site or among monitoring staff be one factor you consider when determining the timing, types, frequency and extent of monitoring activities.
Turnover at the site
Historically a change in personnel at the investigative site warranted an onsite visit by the CRA to ensure that the new research coordinator was trained on the protocol and had been added to the Delegation of Authority log. Depending on the resources at the site, a new coordinator may be able to shadow the RC who is leaving the project. Perhaps they may have been the back-up coordinator and are now taking over primary responsibility for the study. Each situation is unique and should be evaluated accordingly. Setting aside a pool of visits to cover such eventualities makes sense. An on-site visit to meet the new coordinator in person to make sure they understand the protocol and have been trained appropriately is a good idea.
Turnover of monitoring staff is a completely different animal. It is a problem across the industry. A survey conducted by the Avoca group and ACRP at the end of last year indicated that it is one of the biggest complaints from sites. Not so much the turnover, which is inevitable given the nature of the business, but how it is handled and communicated by CROs and Sponsors. One CRA leaving the team will impact several sites, whether they are conducting central monitoring or visiting sites in person.
There is an ongoing excellent series of articles in Clinical Leader about the prevalence of CRA burnout caused by ‘an inherently stressful lifestyle’. (link below). The author, Fiona Wallace, surveyed about 800 CRAs and line managers. Available technology means that CRAs are always ‘on duty’. With travel, expectations of multi-tasking, being on-site for so many days a month, and protocols that are increasingly complex, they may not be able to switch off and often don’t feel supported by management. The focus is on meeting study timelines rather than employee well-being. Rather than raise concerns about their workload and potentially be seen to be lacking capability, they leave. A new CRA is assigned to the site and the cycle starts again. The new CRA is trained on the protocol but often critical pieces of information are not passed along. Site staff complain about ‘breaking in’ a new CRA. Valuable time that could be spent screening for new subjects, is used instead to train the new CRA on site processes. I recall staff at one site telling me that, over the course of a study, they had a different CRA for each monitoring visit. If visits are fewer with the RBM paradigm, and CRA turnover remains at current levels, a different CRA for each of the on-site visits may become the new normal.
What can we do to retain staff?
Presumably staff turnover has been identified as an issue during inspections, if the FDA has included it in the draft guidance as a factor to consider. Employees who feel valued and who have input and some control of their workload are less likely to leave a position. A better approach to retain CRAs might be assignment to just one protocol at fewer sites and a role that encompasses both on -site and remote monitoring. The remote monitoring would give the CRA some office based/travel free days. Being dedicated to one protocol, and being an expert on that protocol, would allow that CRA to truly be a resource for sites. When they identify an issue, they can call the RC to discuss and build that one to one relationship. The successful CRAs, and by extension well performing sites who feel supported, will be those who are given flexibility and discretion in how they manage their workload. Happy employees are more productive employees…. a win for all in the research enterprise. In an era of low unemployment and a scarcity of talent, employers should be asking staff what can we do for you?