Tackling Clinical Trial Staff Burnout Through Technological Advances

The consequences of staff burnout at clinical trial sites can be significant, both for individual staff members and for the organizations they work for. Burnout can, for example, lead to lack of productivity, increased medical errors and reduced patient satisfaction. It can also result in increased staff turnover, exacerbating current staffing shortages. 
 
With clinical trials expanding to include diverse and dispersed populations as well as rare and under-diagnosed diseases, it’s critical that sponsors focus on easing the burden on clinical trial site staff. By working towards creating a supportive and positive work environment, teams can mitigate burnout and retain a motivated and healthy workforce. 
 
What fuels staff burnout in clinical trials?

Staff burnout at clinical trial sites is a complex issue with multiple contributing factors. Understanding those factors is key to implanting strategies to proactively and positively address this major industry challenge.
 
Overwhelming workload is one of the most significant factors driving burnout. Clinical trial staff often must juggle a multitude of tasks, including patient recruitment and screening, data collection and entry, regulatory compliance and communication with sponsors and regulatory bodies. The sheer volume of work – and data handled – can lead to overwhelming feelings. Adding to that, the pressure on staff with unrealistic expectations for clinical trial sites of sponsors and regulatory bodies have an effect on the wellbeing of the staff. These expectations may include unrealistic timelines, tight budgets and stringent regulatory requirements that affect the day-to-day work.
 
It’s common for clinical trial staff to feel like they have little control over their work or little autonomy over the deliverables. They may, for example, be micromanaged by sponsors and regulatory bodies or they may not have the resources they need to do their jobs effectively. This lack of control can lead to feelings of frustration. 
 
In tandem, trial staff may not feel like they have the support they need from their managers, colleagues or organizations. This lack of support can make it difficult to cope with the demands of the job. Additional elements, such as lack of recognition, limited career development options and a no continuous training and resources can also factor into feeling of inadequacy and burnout.
 
The effects of this ‘fatigue’
 
Burnout is a major driver of turnover in the clinical research industry, looking in more detail at the effects it can have on clinical trial operations, there are a number of potentially negative consequences. 
 
Among the consequences, reduced quality of care is a serious byproduct of this challenge, as exhausted staff are more likely to make mistakes, which can put patients at risk. Fatigued workers may also be less able to provide the high level of care that patients deserve because of challenges with productivity in general. 
 
Additionally, decreased productivity is yet another result of staff burnout. Mistakes, for example, in data collection and entry, can jeopardize the integrity of clinical trials data, cause delays and increase overall costs. The potential downstream net results of these factors include delays in patient recruitment and enrollment, which can stall the start of trials and make it difficult to meet recruitment goals and increased risk of regulatory noncompliance as fatigued staff may be more likely to overlook or miss important regulatory requirements.
 
When staff are burned out, they are more likely to leave their jobs, disrupting clinical trials and making it difficult to find and retain qualified staff. This can compound poor staff morale, creating a negative work environment, in turn further exacerbating difficulties attracting and retaining qualified staff.
 
Creating a new and healthier environment
 
To maintain clinical trial momentum, it is important for sponsors, clinical research organizations, and clinical trial sites to work together to create a supportive and positive work environment. A supporting culture will encourage open communication, teamwork, recognition and prevent and address burnout among staff. This strategy involves a multi-pronged approach that includes common sense elements that reduce workload, for example:

• Sponsors and regulatory bodies working with clinical trial sites to ensure that their expectations are realistic, and that staff have the resources they need to do their jobs effectively.
• Offering flexible work arrangements and providing access to mental health resources.
• Encouraging staff to prioritize self-care by taking breaks, exercising and eating healthy foods. 
• Providing opportunities for career development through training and development opportunities to help staff advance their career. Creating clear career paths and providing mentorship opportunities.

The key role of technology fostering a supporting workplace
 
Crucially, technological advancements play a significant role in addressing clinical trial staff burnout by streamlining workflows, automating tasks and providing real-time support. 
 
Collaboration across different stakeholders and technologies can help ease the burden on site staff in several ways:
 
1.     Streamlined communication and collaboration: By utilizing cloud-based platforms and communication tools, clinical trial staff can connect seamlessly across different sites and organizations, facilitating real-time information sharing, task delegation and problem-solving. The creation of multi-sponsor, collaborative technology platforms, for example, supports trial site selection, start-up and management. Having a single point of sign-on for non-patient users removes the need for multiple passwords, means less time logging in and out of systems, reducing the burden of redundant tasks and freeing up time for more meaningful work. 

2.     Standardized processes and tools: Implementing standardized clinical trial processes and adopting standardized technologies can help reduce variability and streamline workflows. This effectively makes tasks more predictable and less time-consuming, which in turn can alleviate stress and frustration for staff, particularly those working at different sites with varying practices.

3.     Shared expertise and knowledge: Collaboration across sites and technologies can foster a culture of knowledge sharing and peer support, allowing staff to learn from each other’s experiences and expertise. This can enhance problem-solving capabilities and reduce the feeling of isolation that can contribute to burnout.

4.     Electronic data capture (EDC) systems: These systems allow electronic collection and management of patient data, reducing the need for manual data entry and transcription errors. This can save time, improve data quality and reduce the risk of regulatory delays.

5.     Virtual collaboration tools: Tools, such as video conferencing and instant messaging platforms, facilitate real-time communication and collaboration among clinical trial staff across different sites and organizations. This can expedite problem-solving, improve decision-making, and reduce the need for travel.

6.     Remote monitoring technologies: These technologies, such as wearable devices and telemedicine platforms, allow clinical trial staff to monitor patient data and provide support remotely. This can reduce the need for frequent on-site visits, improve patient engagement and reduce the burden on clinical trial staff.

7.     Artificial intelligence (AI) and machine learning (ML): AI and ML can be used to automate tasks such as protocol review, data analysis and regulatory reporting. This can free up staff time to focus on more strategic activities, such as problem-solving and decision-making.

8.     Enhanced data sharing and analysis: Integrated clinical trial technology platforms can facilitate the seamless sharing of data across sites, enabling staff to access and analyze data more efficiently. This can expedite regulatory submissions, improve trial oversight and ultimately lead to faster clinical development timelines.

9.     The emergence of eConsent: Legacy paper-based patient consent is slow and cumbersome. As clinical trials expand geographically, electronic consent (eConsent) offers a user-friendly solution designed to support diverse protocols at a global scale. eConsent significantly reduces the burden and stresses on clinical trials staff and supports the move to digital that is transforming clinical trials and patient consent. The flexibility supports all trial types and business models, from decentralized clinical trials to site-based trials, and equips investigators and sponsors to engage patients outside of the site, independent of location. 
 
Mitigating the burnout in clinical trials
Healthcare organizations must prioritize the well-being of their employees, provide resources for mental health support, improve their work-life balance and streamline administrative processes. Investing time and resources into strategies that help reduce the burden and stresses on clinical trial staff, such as deploying advanced technologies, is a win-win for sponsors and sites. Not only does technology advance organizations on many levels but it can support the retention of staff through streamlining workflows, reducing the demands on staff in terms of menial, repetitive tasks, which can improve job satisfaction by freeing up expertise to focus on higher value tasks. 
 
By implementing these strategies, clinical trial organizations can create a more collaborative and supportive environment for their staff, reducing the risk of burnout and improving overall job satisfaction and retention.

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Aruna Adhikari Thapa is a seasoned technology strategist with more than 20 years’ experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges. Aruna holds a B.Sc. in Network Modeling & Simulation and Statistics from Saint Cloud State University, along with an MBA in Strategic Technology Management from Augsburg College. Aruna’s career is marked by her commitment to delivering innovative solutions creating maximum value for end users.