Addressing the Staffing Crisis in Clinical Trials

The clinical trials industry is grappling with a severe workforce crisis. Ninety-five percent of cancer centers report staffing issues, which not only hamper their ability to conduct clinical trials but may also jeopardize the quality and integrity of the research itself. For instance, an editorial published in The Hill warned that clinical trial staffing challenges in the post-COVID era could delay the introduction of new cancer therapies and diagnostic screenings by years. Not only are these delays costly for sponsors but they may actually prevent potentially life-saving therapies from reaching patients in need.

The Root of the Problem

The beginning of the clinical trial staffing crisis can be traced back more than 15 years, to the emerging trend of outsourcing in the clinical research field. This shift led to a new reliance on freelance contractors, creating a cycle of supply-and-demand conflicts and piecemeal solutions that have grown complicated over time.

Unlike principal investigators (PIs), whose professional identities tend to be firmly rooted in the medical centers at which they work, clinical research professionals including clinical research associates (CRAs), clinical research coordinators (CRCs), data entry professionals, and clinical trial data managers often lack a clear professional identity and specific career path. Complicating matters is the reality that in 2024, clinical research positions remain severely under-represented in STEM curricula and healthcare workforce projections.

As a result, most clinical trial staff enter the field by chance, with little awareness of clinical research as a career option, and minimal understanding of what different positions entail. This lack of intentional pursuit has resulted in low commitment and high turnover rates, with turnover rates for clinical research associates hovering around thirty percent. High turnover exacerbates the burden on remaining staff, leading to increased stress, burnout, and further attrition.

The COVID-19 pandemic further complicated issues, prompting a trend widely known as ‘the great resignation’. Between Q1 2021 and Q1 2022, the most experienced clinical trial workers—those aged 40-60 with over a decade of experience—resigned at the highest rates. Specifically, resignation rates among employees with 5-10 years of experience increased by sixty percent from 2020, while resignation rates among clinical trial staff with 10-15 years of experience saw a fifty-five percent increase in 2021 compared to 2020.

Compounding the problem is that the cost of replacing a clinical research coordinator is estimated at $50,000 to $60,000, not including the loss of productivity and potential burnout of other staff members. The result is an expensive cycle of burnout, resignation, and trial delays.

More Data, More Problems

The pressure on clinical trial professionals, particularly CRAs and CRCs, has intensified in recent years. Both jobs are complex, arduous, and demanding, often requiring long hours of mind-numbing manual data copying and validation. The complexity and scale of clinical trial data has increased in the past decade largely due to the development of more sophisticated and accessible medical tests. As a result, Phase III oncology trials now gather an average of 3.5 million data points, a threefold increase in the past decade. This collection of additional data points without a comparable increase in trial staff contributes to staff burnout and, ultimately, to staff turnover.  

Complicating the issue further is that the clinical trial industry has not embraced technologies that could ease staff burden and reduce much of the manual work that trial staff currently struggles with. Today’s clinical trial staff must still navigate multiple systems, technologies, and communication tools throughout the clinical trial lifecycle, all of which require tedious learning curves and repeat logins, adding even more time to an already frustrating process.

Likewise, clinical trial staff are still required to manually transfer data from the medical centers’ electronic health records (EHRs) to the sponsors clinical trial database, and to verify the data manually, a process which adds hundreds and hundreds of laborious hours to every trial.

Many of these problems could be solved by available technological solutions, but pharma and biotech companies remain resistant to change, and the adoption of proven solutions remains painfully slow.

Potential Solutions

Addressing the clinical trials workforce problem must be done from the ground up. To begin with, universities and hospitals must work together to establish global standards for training and qualification. This approach will create standardized roles across the industry and establish clinical trial positions as part of a respected, sought-after career path. Once the educational framework is in place, pressure must be put on the U.S. Bureau of Labor & Statistics to recognize clinical trial positions in their Occupational Outlook Handbook which current does not list any industry-specific positions.

At the same time, a concerted effort must be made to improve career development opportunities, compensation, and job satisfaction for clinical trial staff, all of which can help reduce attrition rates.

Implementing technological solutions to ease the workload on clinical trial staff is essential for making these roles more appealing to both current and prospective employees.

Reversing the Shortage

The current lack of clinical trial professionals is a serious concern that's compromising the ability to conduct high-quality clinical trials. But there is hope. With a combination of the right technology that removes the most tedious manual labor from the role; a change in attitude from workforce agencies; and collaboration between academic institutions and pharma companies to turn clinical trial roles into well-known and well-defined careers, new talent can be attracted to work in clinical research and speed critical advances in pharma and healthcare.

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