Combating Burnout in Clinical Research

This is a modified version of an article that first appeared in STAT. Check out the original here. 

In the midst of battling a pandemic, healthcare professionals are also battling burnout and mental illness. Though people recognize the struggles of physicians and nurses, clinical research professionals often get left out of conversations about emotional exhaustion. 

Burnout affects clinical research staff as well as the physicians and nurses they support. And when burnout hits, it can lead to employee turnover and slow, inefficient clinical trials. 

We need to understand why burnout occurs among research professionals if we want clinical trials to be fast, safe, and effective. By taking care of clinical research staff, we can also take care of physicians, nurses, and patients. 

How Bad is Healthcare’s Burnout Problem? 

Although burnout can occur in any profession, it’s especially prevalent in healthcare. In 2017, 43.9% of physicians reported at least one symptom of burnout on the Maslach Burnout Inventory. 

These symptoms included a loss of enthusiasm for work, cynicism, and a low sense of accomplishment. The overall burnout rate for U.S. adults in other professions was 28.1%. 

The research on burnout among clinical research staff is less recent and extensive than the research on physicians. However, one of the few studies conducted on clinical research coordinators showed that 44% reported emotional exhaustion, a major component of burnout. 

This statistic suggests that clinical research coordinators suffer from burnout as often as physicians do and far more often than the average U.S. worker. 

Why is Burnout So Common in Healthcare? 

Some of the burnout in clinical research comes from problems facing the entire healthcare system, while other sources of burnout are unique to clinical research. 

Sources of stress affecting all healthcare providers include confusing hospital and healthcare policies, complex electronic data systems, and the emotional exhaustion that comes from seeing patients struggle despite their best efforts. Emotional exhaustion can also come from comforting patients or communicating with patients’ families. 

Emotional exhaustion dramatically and tragically increased during the pandemic. Healthcare workers not only had to treat thousands of seriously ill patients, but also had to engage in pandemic triage and run the risk of exposure to COVID-19. 

Since the start of the pandemic, 50% of physicians report experiencing inappropriate anger, tearfulness, or anxiety. 30% say that they feel hopeless or purposeless, and 58% now say that they are burned out. 

Why is Burnout So Common in Clinical Research? 

Clinical research coordinators are also struggling during the pandemic. 67.7% of clinical research staff said that stress was adversely affecting their work performance in 2020, and 73.9% were thinking of changing jobs. Though clinical researchers were not in ICUs or emergency departments, many of them were still treating patients who could have been exposed to COVID-19. 

Clinical researchers also had to change their priorities because of the pandemic. At the peak of lockdowns in May 2020, 1,162 clinical trials were suspended in the U.S., including oncology, neurology, cardiovascular, and rare disease trials. Many clinical research staff members had to abruptly switch to COVID-19 treatment or vaccine trials. 

By August 2021, 1,447 COVID-19 clinical trials had been completed in just over 1 year. The pressure of completing so many trials in such a short time, as well as restarting other disease trials, fell on clinical research staff. 

What Factors Lead to Burnout in Clinical Research?

Clinical research professionals face many of the same struggles as physicians and nurses, like confusing hospital policies, worrying about patients, and the COVID-19 pandemic. But clinical research work also comes with specific stressors that can lead to burnout. 

A study on burnout in Italian clinical trials found that clinical research coordinators name sponsor contracts, workload, and a lack of recognition as the main sources of stress in their jobs. These statistics line up with my personal experiences working in clinical research as well as the experiences of many of my colleagues. 

1. Sponsor and site expectations

31.2% of clinical research coordinators (CRCs) said they experienced stress because of contracts with sponsors. During an informal talk with my colleagues who worked at clinical research sites, they mentioned being overwhelmed by protocol changes, data entry requirements, and sending, updating, and resending documents. 

At the same time, clinical research associates who worked for sponsors and CROs reported stress from strict study timelines. Former monitors talked about feeling pressured to complete studies on time, though they recognized that sites had to cope with complicated protocols. These accounts are anecdotal, but they support the burnout study’s findings. 

One solution to these issues is to establish better communication between sites and sponsors. Storing all documents and data in an online platform that the site and the sponsor can access may save sites from sending documents back and forth. It could also help sites see when protocols have changed and sponsors see when sites are experiencing difficulties. 

2. Overwhelming workload

One of the primary factors in clinical research burnout is high daily workload. My colleagues from clinical research described early mornings and late nights, waking up at 4 or 5 a.m. for meetings in different time zones and staying logged on until 8 p.m. Clinical research associates also have to contend with the stress of traveling, staying on the road 18% of the time.

On the site side, 20.5% of clinical research coordinators reported stress because of their workload. Clinical research coordinators sometimes stay longer than required to check on patients, and they struggle with the number of tasks they must complete in a day. But turnover is also a major issue.

The CRO industry has a 24-29% turnover rate. For comparison, the average turnover rate across the U.S. in 2018 was just 15%. And since clinical research sites and sponsors have to spend close to $25,000 to hire and train new employees, they may opt to give additional duties to current employees instead. Strict salary budgets and high demand can also make it hard to find new employees. 

Even when new people are hired, it takes roughly three months to train them, so current employees will have an increased workload for at least that long. Whether they can afford new staff members or not, sites and sponsors need to use staff’s time more efficiently. Technology can remove the need for mundane tasks like printing, copying, and manually redacting PHI, allowing CRAs and CRCs to focus on patient interaction and important documentation.  

3. Lack of appreciation

17.8% of clinical research coordinators said that they were frustrated by a lack of recognition for their skills. My colleagues with years of clinical research experience said they often didn’t get to hear the results of studies they helped with or receive a thank you for their efforts. They were also pressured to complete data entry and didn’t receive credit for non-revenue-producing activities, like talking to or comforting patients. 

This lack of recognition can lead to a low sense of efficacy, one of the leading causes of burnout. By listening to clinical research staff’s feedback about workloads, resources, and timelines, we can increase their sense of efficacy and lower rates of burnout. 

How Do We Beat Burnout? 

Clinical research staff can make some personal changes to prevent burnout, but most of the changes will need to take place on an institutional level among research sites, CROs, and sponsors.

Personal changes that can prevent burnout include exercising, eating a healthy diet, getting enough sleep, spending time with loved ones, and practicing mindfulness. But that raises the question: how can CRAs or CRCs do any of that if they’re overwhelmed by their workload and impossible expectations? 

This is why clinical research sites must engage in institutional changes to prevent burnout. These could include:

• Hiring more staff
• Defining staff duties more clearly
• Asking employees for feedback about their workload
• Holding critical reviews of expectations, timelines, and budgets with sponsors to ensure appropriate resources are allocated
• Adding software to reduce the amount of time spent on specific tasks

Adding efficient software that matches their workflows is an especially good option for sites, sponsors, or CROs that can’t hire more staff due to budget concerns. If employees can use software to cut down on redundant processes, it gives them time back to take care of themselves and their families. 

Joining the Fight Against Burnout in Clinical Research

Although all healthcare professionals can struggle with burnout, clinical research staff face specific challenges that are too often overlooked. By setting realistic expectations, managing workloads, and showing appreciation for clinical research staff, research sites, sponsors, and CROs can take care of the people who make clinical trials happen. And if you want to know how technology can help, check out our guides to tasks like study start-up and FDA approval. 

Sources

“Burnout” in a clinical research trial environment. Global Research Nurses. (n.d.). https://globalresearchnurses.tghn.org/articles/burnout-clinical-research-trial-environment/

Cagnazzo, C., Filippi, R., Zucchetti, G., Cenna, R., Taverniti, C., Guarrera, A. S., Stabile, S., Federici, I., Monti, M., Pirondi, S., Testoni, S., & Fagioli, F. (2021). Clinical research and burnout syndrome in Italy – only a Physicians’ affair? Trials, 22(1). https://doi.org/10.1186/s13063-021-05158-z

Dean, W., & Talbot, S. G. (2020, November 24). Beyond burnout: This surge of covid-19 is bringing burnover. STAT. https://www.statnews.com/2020/11/25/beyond-burnout-health-care-workers-covid-19-surge-burnover/.

Getz, K. A. (2014, February 7). Baseline measures of global CRA workload and utilization. Pharmaceutical Business Review. https://www.pharmaceutical-business-review.com/news/baseline-measures-of-global-cra-workload-and-utilization-by-kenneth-a-getz-070214-4173580/. 

Gwede, C. K., Johnson, D. J., Roberts, C., & Cantor, A. B. (2005). Burnout in clinical research coordinators in the United States. Oncology Nursing Forum, 32(6), 1123–1130. https://doi.org/10.1188/05.onf.1123-1130

Mercer. (n.d.). North American employee Turnover: Trends and effects. Mercer. https://www.imercer.com/articleinsights/North-American-Employee-Turnover-Trends-and-Effects. 

The Physicians Foundation. (2020, September 18). The Physicians Foundation 2020 physician survey: Part 2. The Physicians Foundation. https://physiciansfoundation.org/physician-and-patient-surveys/the-physicians-foundation-2020-physician-survey-part-2/.

Sasangohar, F., Jones, S. L., Masud, F. N., Vahidy, F. S., & Kash, B. A. (2020). Provider burnout and fatigue during the covid-19 pandemic: Lessons learned from a high-volume intensive care unit. Anesthesia & Analgesia, 131(1), 106–111. https://doi.org/10.1213/ane.0000000000004866

Search of: Completed Studies: Covid-19 – list results. Home – ClinicalTrials.gov. (n.d.). https://clinicaltrials.gov/ct2/results?cond=COVID-19&Search=Apply&recrs=e&age_v=&gndr=&type=&rslt=. 

Shanafelt, T. D., West, C. P., Sinsky, C., Trockel, M., Tutty, M., Satele, D. V., Carlasare, L. E., & Dyrbye, L. N. (2019). Changes in burnout and satisfaction with work-life integration in physicians and the general us working population between 2011 and 2017. Mayo Clinic Proceedings, 94(9), 1681–1694. https://doi.org/10.1016/j.mayocp.2018.10.023

Stroo, M., Asfaw, K., Deeter, C., Freel, S. A., Brouwer, R. J., Hames, B., & Snyder, D. C. (2020). Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. Journal of Clinical and Translational Science, 4(4), 331–335. https://doi.org/10.1017/cts.2020.22 

Studna, A. (2021, April 15). Turnover for clinical monitoring remains high. Applied Clinical Trials Online. https://www.appliedclinicaltrialsonline.com/view/turnover-for-clinical-monitoring-remains-high. 

Valid and reliable survey instruments to measure burnout, well-being, and other work-related dimensions. National Academy of Medicine. (2020, October 18). https://nam.edu/valid-reliable-survey-instruments-measure-burnout-well-work-related-dimensions/.

Weill, D. (2021, July 3). An open letter to 2021 medical school graduates. STAT. https://www.statnews.com/2021/06/27/an-open-letter-to-2021-medical-school-graduates/. 

Xue, J. Z., Smietana, K., Poda, P., Webster, K., Yang, G., & Agrawal, G. (2020, September 10). Clinical trial recovery from COVID-19 disruption. Nature News. https://www.nature.com/articles/d41573-020-00150-9.