If you ask most CROs and Sponsor companies how clinical monitors (CRAs) are assigned to clinical study sites, the answer will be consistent: geography. Traditionally, CROs have employed a regional monitoring strategy for clinical trials, meaning a set of regionally-based CRAs (who often work remotely) are assigned to clinical study sites in their region. The main benefit of this model is a potential reduction in travel time and associated costs, since CRAs live and work in the same region as the study sites.
While travel related cost savings can be compelling, it’s important to consider the entire picture. In a traditional regional model, CRAs are often assigned to multiple studies at any given time, are required to handle grueling travel schedules with multiple site visits a week, and are forced to cope with the challenges of working remotely. Job satisfaction, monitoring quality, and project team cohesiveness can suffer and leave us wondering if there are alternatives to the regional model.
One viable alternative to the traditional regional model is a non-regional monitoring strategy. In a non-regional model, CRAs work in a central location (e.g. in the CRO’s local area) and are assigned to studies based on therapeutic expertise and availability, instead of geography. As a rule of thumb, for a typical Phase II study, 1 CRA is assigned to 8 to 10 study sites. Site assignments are made with efficiency in mind—one CRA might be assigned to all sites in a particular area of the country to allow for visit looping. There are many potential benefits to this alternative model, and we list four of the most significant benefits below:
1. Increased monitoring efficiency and quality
In a non-regional monitoring model, CRAs are assigned to protocols and sites based on experience, not location, which means that CRAs can be assigned to fewer protocols simultaneously (preferably just one protocol). This model allows CRAs to be true experts on their assigned protocol(s), instead of juggling several different protocols. Protocol-focused CRAs are able to provide higher quality monitoring and better attention to their study sites. This model also reduces the number of CRAs that are needed to monitor a study and leaves the project team with a smaller, more focused team, which reduces administrative costs and leads to a more cohesive team.
2. Reduces CRA burnout
One of the most reported causes of work-associated stress for CRAs is the need to juggle multiple protocols, which is a necessity in the traditional regional model. CRA burnout can have significant cost and time implications for clinical trials, negatively affect monitoring quality and efficiency and team dynamics can suffer. Using the non-regional monitoring model allows CRAs to focus on fewer priorities, which leads to more engagement and less burnout.
3. Better project team integration
In a non-regional monitoring model, CRAs are more fully integrated into the project team, both logistically (e.g. either working in the same office or able to easily attend meetings in the office) and functionally (e.g. being a true expert on one or two projects). This structure provides a sense of belonging, better team cohesiveness, more efficient meetings and increased ownership. Overall, this model contributes to CRA job satisfaction and a greater loyalty to the company, which often results in better CRA retention rates.
4. Better set-up for risk-based monitoring
As the industry moves toward risk-based and centralized monitoring, it will be more critical than ever that CRAs work closely with the rest of their project team. Specifically, they will need to have strong relationships and seamless handoffs with project team members in data management and biostatistics who can assist with some of the strategies necessary to successfully implement a risk-based strategy. This type of team integration is more feasible in a non-regional monitoring model.
The clinical trial monitoring landscape is changing right now. The FDA’s recent issuance of its “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” demonstrates that the industry’s traditional approach to clinical monitoring can be re-configured in favor of more agile, efficient, and creative strategies. A non-regional monitoring model has the potential to increase the quality and efficiency of monitoring while increasing overall CRA job satisfaction and project team cohesiveness.