Clinical Operations, the backbone of the clinical trials sector, has been impacted by the COVID-19 pandemic. Post-pandemic, many clinical operations personnel are adopting a Work-from-home (WFH) strategy. This article discusses the challenges faced by Clinical Operations professionals in today’s post-COVID-19 pandemic environment, such as inclusion, burnout, and turnover intention, and provides recommendations for how biopharmaceutical organizations can improve the well-being of their Clinical Operations workforce.

The COVID-19 Pandemic’s Impact on Jobs and the Rise of Work-from-Home (WFH)

The COVID-19 pandemic brought about a monumental shift in organizational operations, propelling work-from-home (WFH) to the forefront for numerous professionals. This transition birthed out of health and safety necessities, ushered in distinct challenges across industries. Clinical Operations stood right at the center of this whirlwind. The WFH trend, while beneficial in many aspects, did introduce complications, especially for clinical trials requiring physical supervision. The workforce’s dynamics, responsible for these operations, also underwent a significant transformation. A recent research paper delves deep into this WFH landscape, spotlighting how sentiments around inclusion, job satisfaction, and turnover have pivoted in various functional areas during the pandemic, with a particular emphasis on Clinical Operations.

Deciphering Work-from-home (WFH) Trends Post the COVID-19 Pandemic

The COVID-19 pandemic gave rise to unparalleled changes in work methodologies, predominantly within the drug development domain. The Tufts Center for the Study of Drug Development embarked on an exploration into this transformative phase, attempting to understand evolving work-from-home (WFH) preferences and patterns in the return-to-office (RTO) era. Their exhaustive study offers insights into present-day Work-from-home (WFH) setups and future inclinations, revealing the industry’s heartbeat as it sails through the post-pandemic waters. The research paper also delved into three facets impacting worker mood: inclusion, burnout, and turnover intention.

LEFT: The pie chart depicts the current Return-to-Office (RTO) arrangements in the drug development industry. A significant 51% of the workforce currently Work-from-home (WFH), while 23% are in a hybrid setup, and 26% work on-site. RIGHT: This pie chart displays the preferred RTO arrangements. It’s evident that 45% of the respondents prefer going into the office once a week. Interestingly, the second-highest preference (17%) is for monthly office visits, and closely following that, 14% of respondents would like to go into the office every day.
  • Inclusion: In the workplace context, inclusion refers to the degree to which diverse employees are valued, respected, accepted, and encouraged to participate in the organization fully. Clinical Operations grapples with fostering an inclusive environment. While not at the absolute bottom, it trails behind the data science function, hinting at potential improvement areas. For example, Data Science may be more interesting and have unique challenges that manifest a more inclusive backdrop than Clin Ops. However, some functions, like Marketing, are even more challenged, reinforcing that Clin Ops isn’t alone in this struggle.
ClinOps ranked second, trailing behind the data science function, but is better than most functions in biopharma.
  • Burnout: Burnout is a state of emotional, physical, and mental exhaustion caused by prolonged and excessive stress. It occurs when individuals feel overwhelmed, emotionally drained, and unable to meet constant demands. Clinical Operations finds itself in the midst of the burnout spectrum. Given the pivotal nature of clinical trials, even modest burnout levels ring alarm bells. It brings to light potential impacts on work quality and the overall well-being of employees.
Clinops
Clinical Operations ranked in the middle of burnout (representing physical, emotional, and mental exhaustion) compared to other functions.
  • Turnover Intention: Turnover intention refers to an employee’s personal decision to leave their current job or organization. Clinical Operations showcases alarming turnover intention levels, positioning itself higher than many other sectors. This paints a worrisome picture, indicating that Clinical Operations professionals may be contemplating alternative career paths more frequently.
ClinOps appears to have one of the worst turnover rates (Turnover intention signifies an employee’s intention or likelihood to leave their current job or organization) compared to other functions.
  • Holistic Analysis: When aggregating the key metrics of Inclusion, Turnover Intention, and Burnout into an average score, Clinical Operations (Clin Ops) unfortunately finds itself positioned on the lower end of the spectrum among functional areas. This cumulative ranking underscores Clin Ops’s multifaceted challenges, hinting at a broader need for introspection and strategic action. While individual metrics provide detailed insights into specific areas, this overall assessment is a holistic indicator of the health and well-being of Clin Ops professionals compared to their peers in other functions. The positioning suggests that while Clin Ops is managing certain aspects effectively, there are overarching areas of improvement that warrant attention to ensure the domain remains robust and resilient in the face of industry demands.
When all three factors are aggregated, Clinical operations ranked on the lower end of many functions,

The Impact of Poor Clinical Operations on Clinical Trials

Each clinical trial is a multifaceted endeavor, presenting unique challenges that demand a combination of mental agility, imagination, and motivation for effective resolution. The metrics of Inclusion, Burnout, and Turnover Intention play pivotal roles in influencing how these challenges are addressed:

  • Inclusion: In navigating the intricate challenges of clinical trials, an inclusive environment emerges as a key asset. Teams that champion diversity, with members from varied backgrounds and experiences, can tap into a richer array of problem-solving techniques. Such teams can conjure multiple solutions, leveraging a wide spectrum of experiences and insights. Conversely, a non-inclusive environment might foster homogenous thinking, potentially curtailing creativity and limiting the range of solutions explored. For example, when confronted with recruitment hurdles in a particular demographic, a diverse team could provide localized insights or culturally tailored approaches that might elude a more uniform team.
  • Burnout: The debilitating effects of burnout can significantly impede the imaginative and analytical faculties needed to tackle the multifarious challenges of clinical trials. Professionals grappling with burnout might lack the cognitive flexibility to think innovatively or the drive to seek novel solutions. This can result in protracted issue resolution, causing delays, or even lead to sub-optimal solutions that merely address superficial symptoms rather than delving into the root causes.
  • Turnover Intention: Elevated turnover intentions can precipitate a loss of invaluable knowledge and experience crucial for surmounting recurring or nuanced trial challenges. As seasoned professionals contemplate departure, the trial stands to lose not just their immediate expertise, but also their historical knowledge of past impediments and their resolutions. Such a scenario might see teams redundantly tackling previously resolved challenges or overlooking efficient strategies discovered in the past.

In essence, adeptly navigating the challenges intrinsic to clinical trials requires a synthesis of diverse thought, sustained motivation, and accrued expertise. Prioritizing inclusivity, mitigating burnout, and curbing turnover intentions are not mere organizational goals; they are intrinsically linked to the very efficacy of clinical trial operations.

Recommendations to Bolster Clinical Operations

  • Tailored RTO Strategies: Recognizing the diverse nature of roles within the drug development industry, organizations should design tailored RTO strategies. A one-size-fits-all approach may not be efficient. For instance, a setup that benefits clinical project managers might not be suitable for CRAs, study coordinators, or PIs.
  • Employee-Centric Approach: Organizations should maintain a strong focus on the employee experience. While productivity and efficiency are paramount, employee well-being, feelings of inclusion, and reducing burnout should be top priorities. This can be achieved through regular feedback sessions, employee surveys, and open communication channels.
  • Global Perspective: Considering expanding operations or collaborations outside the U.S.? It’s crucial to understand the cultural and professional nuances of Work-from-home (WFH) preferences across different regions. A strategy that works well in one country might need adjustments in another.
  • Performance Metrics: While it’s essential to understand employee preferences and feelings, organizations should also assess the tangible impact of different work arrangements on productivity. Regular performance reviews, team audits, and project assessments can provide insights into the efficiency of different setups.
  • Wellness Programs: Continue to prioritize employee wellness. Programs like remote mental health services, virtual yoga sessions, meditation courses, or digital detox hours can be instrumental in managing stress and reducing burnout.
  • Training & Development: As before, continuous training remains vital. Equip teams to adapt to new digital tools efficiently, especially in the context of remote trial monitoring.
  • Inclusion Initiatives: Foster an inclusive environment with team-building exercises, diversity training, and open forums. Celebrate the diverse backgrounds of team members to enhance understanding and camaraderie.

Summary

The Covid-19 pandemic reshaped work dynamics in the drug development industry, with Clinical Operations (Clin Ops) facing unique challenges. The study by the Tufts Center highlights issues like inclusion deficits and high turnover intentions in Clin Ops. The industry’s stance on Return-to-Office (RTO) strategies is pivotal. As we move forward, tailored strategies focusing on wellness, training, and inclusion are essential after the COVID-19 pandemic. A one-size-fits-all approach won’t suffice. Instead, a balanced focus on productivity and employee well-being is crucial for Clin Ops’ future resilience and efficiency.

References: Tufts Center for the Study of Drug Development. (2023). Impact of the COVID-19 pandemic on Clinical Operations in the drug development industry.

Moe Alsumidaie
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Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.