The Critical Role of CRAs
In this post, I’ll talk to the critical need of finding, training, and retaining Clinical Research Associates (CRAs). CRAs are a critical factor in the success of clinical trials. They are on the frontline ensuring that trials are run according to the protocol and meet regulations in a manner that protects the safety and welfare of the patients who participate in clinical trials. They are key members of the team who have the unique perspective of being able to help identify potential issues at the site level based on their first-hand observations. By visiting sites, CRAs are able to build strong site relationships that allow trials to be completed effectively and efficiently.
In fact, I believe their role is instrumental in controlling R&D costs, which according to the Tufts Center for the Study of Drug Development are increasing at a CAGR of 8.5% resulting in the cost of developing a new drug at $2.6 billion. How important are experienced CRAs? Experienced CRAs can benefit clinical trials by increasing enrollment rates, identifying noncompliance related to complex study procedures, ensuring that data collected adhere to the study protocol, and ensuring that the sites meet regulations and state and local laws, and are within Good Clinical Practice (GCP). Qualified CRAs can deliver high quality data on time and within budget.
Given the critical role of CRAs, we must understand the essential mix of education and skills they need to be effective. CRAs require formal scientific education and strong people and relationship-building skills. CRAs also need to be able to understand guidelines and regulations, work independently, develop relationships with investigators and study coordinators, and train others on study processes.
Recently, we have seen a rise in the demand for CRAs. Currently, the number of CRAs being trained each year is falling behind the demand, which leaves a CRA shortfall. This dynamic has increased the overall costs of monitoring and has put pressure on companies to identify and hire CRAs with good training and experience.
3 Industry Factors Impacting the Demand for CRAs
We have identified three industry factors that create demand for CRAs, and hurdles in retaining qualified CRAs.
- Trials outpacing number of qualified CRAs — The number and complexity of clinical studies is increasing which increases the demand for CRAs. However the addition of newly qualified CRAs is not keeping pace with the demand. Additionally, many experienced CRAs are moving into project leadership roles therefore contributing to the CRA shortfall.
- Lack of training and competency standards — The industry has relied upon on-the-job training for entry-level CRAs to learn their role. While this works well in most career advancement environments, the training has not provided consistent and satisfactory results and has led many sponsors to require a minimum of two years of experience for newly hired CRAs. While the two year minimum is an arbitrary measure that does not indicate competency, it does provide sponsors with some level of assurance that CRAs can effectively perform their job. The Association of Clinical Research Professionals (ACRP) has identified a lack of standardized training and competency assessments as a risk in conducting clinical trials. As a result, the ACRP has a task force to establish core competencies for clinical trials staff to clearly outline areas for training and development. Standard core competencies and training programs can create a more normalized career advancement path for CRAs.
- Low job satisfaction — CRAs are managing increased workloads due to the shortage of CRAs, traveling more to oversee larger geographies, and spending more time in the office to complete tasks. These demands lead to lower job satisfaction.
3 Tips for Retaining CRAs
Not only is it challenging to find qualified CRAs, but once a company finds good CRAs, they want to keep them. We have three recommendations to overcome the challenges in finding, hiring, and retaining qualified CRAs.
- On-going training — The best CRAs start out with outstanding entry level training and receive ongoing training to ensure a thorough understanding of study protocols and to keep up with industry guidelines and regulations. In our experience, training is a critical success factor, and a well trained CRA can be more effective than a lesser-trained CRA with a higher number of years of industry experience.
- Well-prepared protocols — A well-developed study protocol clearly outlines patient inclusion and exclusion criteria, the clinical monitoring plan, how to report adverse events and serious adverse events, as well as how site data will be collected and verified. CRAs rely on the study protocol to guide their activities, and a well-developed protocol generates higher quality data with less time and effort needed in site monitoring and data clean-up activities.
- Partner with a respected CRO — Partnering with a trusted CRO that consistently provides well trained and experienced CRAs is a great alternative to having to find and train CRAs on your own. Great CROs typically have access to personnel that are not readily available to others, have CRAs who have received unique therapeutic training or hands on experience, and are experts in managing time, which can help eliminate the carrying cost of CRAs during periods of non-utilization.
The life-sciences industry continues to evolve to discover and test new treatments and bring them to market more quickly and at a reduced cost. The CRA role is critical to the efficient conduct of clinical trials and there are steps you can take to ensure you have the best CRAs working on your clinical trials.
We want to hear from you. Share with us how you’re changing the way clinical trials are being conducted and how you’re finding, training, and retaining CRAs.