Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, describes four benefits of using a non-regional monitoring strategy for clinical trials versus a traditional regional model.
“If you ask most CROs and Sponsor companies how clinical monitors are assigned to study sites, the answer is typically geography,” said Tara Gladwell, vice president of Operations for Rho. “One viable alternative to the traditional regional model is a non-regional monitoring strategy where CRAs work in a central location and are assigned to studies based on therapeutic expertise and availability, instead of geography.”
The main benefit of the traditional regional model is a potential reduction in travel time and associated costs, since clinical monitors (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. As a result, job satisfaction, monitoring quality and project team cohesiveness can suffer.
In a non-regional model, site assignments are made with efficiency in mind. There are many potential benefits to this alternative model, and Rho has provided four of the most significant ones 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.
“It’s clear that 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 and should be re-configured in favor of more agile, efficient, and creative strategies,” added Gladwell.
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.
To learn more about Rho, please visit www.rhoworld.com.
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 25 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.