Employee turnover rates across the CRO industry are incredibly high. In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs. As a Sponsor selecting a CRO, why should this matter to you? The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project. Project team stability can have a significant impact on the quality of execution, ability to meet timelines, the amount of time and energy you will need to put into oversight, and site relationships. While no CRO can guarantee zero turnover on your team, the ideal situation is that the team you meet during the selection process will be the same team present during study start-up and the same team at project close out.
Clinical studies are complicated. Over the course of a study, team members become entrenched in the details of the study—understanding the protocol, knowing the details in study plans like the data management plan and the clinical monitoring plan, and participating in investigator meetings and other study specific training. As a result, things run smoothly. Problems are less likely to be missed, risks are identified earlier, and fewer errors are made. There is a human aspect as well. CRAs that have a chance to develop relationships with their sites are more likely to catch on when something is amiss. They know which sites may need a little more attention to keep up with enrollment projections. Strong working relationships between functional area leads mean smoother hand-offs as well. When the data manager and biostatistician have been working together from the outset, there are fewer surprises when it comes time for database lock.
New team members mean additional training, time spent reviewing study documents, and time getting up to speed on the study. Even if it is a fixed price contract so there is no direct cost impact, the additional time spent on team member transitions may very well impact key milestones.
Increase in oversight
Your time is valuable. As a Sponsor, you have a responsibility to provide oversight for your study. With a stable team and proven track record, it is likely that over the course of the study you can back away from the level of oversight you are providing—how much time you spend reviewing status reports, how much detail you need in your reports, how frequently you meet with your CRO. However, when key team members leave and new ones are added, the risk increases which means your scrutiny needs to increase.
Sites that meet their enrollment projections and produce high quality data are crucial to the success of your clinical trial. Consistent communication and strong relationships with their assigned CRA are needed to get the best performance out of your study’s sites. If their CRA or other main contacts keep changing, it is hard to build and maintain those relationships.
Given that low turnover is so important, what can you do? When it comes time to select a CRO for your next clinical study, make sure to ask about turnover rates, and specifically, about CRA turnover. You should look for a CRO with an overall turnover rate around 10% and a CRA turnover rate of less than 15%. Pay particular attention to the longevity of key team members. Look for a team where most of the key team members have been with the company at least 3-5 years. Finally, talk to prospective CROs about what they are doing to ensure team stability and how they will handle any turnover that happens during your project.