After years of studying the potential benefits of a new candidate drug or medical device, researchers put it to the test on the patients themselves in clinical trials. This bridges the gap between knowledge and application, ensuring that novel medical treatments are effective and safe to use.
The success of a clinical trial relies on the people functioning on both sides of the operation: the trial staff and the trial participants. Unfortunately, research organizations commonly struggle with high staff turnover in clinical trials, leading not only to trial delays but also to inadequate data. To facilitate positive outcomes for medical populations, it’s important to explore the impact of staff turnover at different stages of the clinical trial life cycle and devise strategies to minimize staff turnover.
The Dangers of Staff Turnover in Clinical Trials
Staff turnover refers to the number of employees who leave an organization. According to the most recent Clinical Research Organization Insights Report by BDO, the turnover rate among U.S. clinical trial associates was 32% in 2021, while the rate among all clinical monitoring roles was 28%. The high churn likely stems from the demanding nature of the work, the time commitment it requires, and the tendency of turnover to beget further turnover as the remaining staff takes on additional duties to compensate for the lost staff.
The implications of such high staff turnover pervade every stage of the clinical trial life cycle.
- Discovery and Preclinical: At the discovery and preclinical stages, a lack of sufficient staff can create an unstable foundation on which to build a clinical trial. Aside from delayed trial initiation and other timeline disruptions, high turnover during planning can introduce gaps in institutional knowledge—an essential ingredient in designing a good trial. The impact of such gaps may be more profound in trials for medical devices, in which highly specialized technical expertise is key.
- Early Clinical: Because the early clinical stage comprises patient recruitment and enrollment, staff turnover at this point could mean losing experienced members who have established relationships with potential trial participants or inconsistent implementation of recruitment strategies and protocols. In either case, the coordinators may end up with an inadequate participant pool, potentially skewing the trial’s findings.
- Clinical: Once you reach the clinical stage, staffing shortages may introduce additional problems relating to your timeline and trial accuracy. Training replacement staff on device functionality, operation, and safety operations can take considerable time, while an inexperienced or understaffed team can lead to inconsistencies in data recording and documentation. In terms of monitoring, knowledge gaps may cause a failure to adhere to standard operating procedures and participants’ dissatisfaction, which can lead to dropout.
- Late Clinical: The timeline disruptions and knowledge gaps introduced earlier in the clinical trial life cycle are likely to extend into the late clinical phase. The delayed data collection becomes delayed analysis and reporting. Inconsistent data recording becomes inconsistent analysis methodology and data interpretation. Consequently, the clinical trial team has difficulty preparing accurate, comprehensive reports and may encounter further delays in meeting regulatory submission deadlines.
- Manufacturing and Marketing: If an understaffed trial runs to completion, additional challenges may await in the manufacturing and marketing stages, particularly in terms of interrupting manufacturing and slowing commercialization, delaying the product’s presence in the market.
Strategies to Minimize Staff Turnover in Clinical Trials
Given the broad array of challenges associated with understaffed clinical trials, what can research organizations do to minimize turnover? Here are some strategies to consider:
- Establish clear roles and responsibilities: When team members know exactly what’s expected of them, they’re much more likely to produce desirable outcomes and avoid frustration, which helps to boost morale and prevent burnout.
- Identify staff with proven experience: The clinical trial process is long, with an array of specialty positions to fill. It’s critical to tap into a large candidate pool, identify individuals with specific experience, and assess how likely they are to be retained for the full trial.
- Provide constructive feedback: Clarifying staff objectives helps them understand how to do their job and what constitutes high-quality work at every step of the life cycle.
- Foster a collaborative and supportive work environment: Employees in any space are better capable of overcoming burnout if they feel a sense of belonging and connection to their workplace.
- Provide comprehensive training and professional development opportunities: Staff members who receive opportunities to learn and advance in their clinical or life sciences careers tend to be more engaged with their work and feel that their employer has invested in their growth.
- Implement recognition and incentive programs: Acknowledging employees’ efforts and rewarding performance can be effective morale boosters.
- Involve staff in decision-making: Inviting input is an excellent way to show staff members that you value them, and empowering them to make key choices helps to engage them more solidly in both the work and the team.
Clinical trials can be challenging to plan, design, and execute, so you need as many capable minds and hands as you can muster. Implementing proactive strategies is crucial for retaining the skilled staff you need throughout the clinical trial life cycle.
Leverage our staffing and consultation services to help you build, maintain, and optimize your team. For further guidance on how to overcome clinical trial challenges, get in touch with Medix today.