Can Clinical Trials Overcome Their Staffing Problem?

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A severe workforce crisis is handicapping the clinical trials industry, with serious knock-on effects for the availability of new therapies and treatments. According to research, as many as 95% of all cancer research centers report staffing issues, leaving them unable to run clinical trials and undermining the quality and integrity of the research.

Some companies are still working on trials that were delayed by COVID-era staff shortages, meaning that therapies that should have hit the market a year or two ago are still in process. Longer trials mean higher costs, which eventually trickle down to consumers in the form of hefty price tags and can deter other sponsors from beginning trials. Additionally, delays in introducing new treatments leave patients without options, affecting their prognosis.

Yet the current staffing shortage shouldn't be a surprise to anyone. It's a problem that's several years in the making and requires a multi-faceted approach to resolve. In this article, we'll examine the causes of the clinical trial staffing crisis and discuss ways to alleviate it.

The Root of the Issue

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 reliance on transient freelance contractors, creating a cycle of supply-and-demand conflicts and piecemeal solutions that have only worsened over time.

Principal investigators (PIs) generally have a firm professional identity that's firmly rooted in the medical centers at which they work. This makes it a well-defined profession with a clear entry path. But this isn't the case for other clinical research personnel.

Roles such as clinical research associates (CRAs), clinical research coordinators (CRCs), data entry professionals, and clinical trial data managers are poorly defined, without an evident on-ramp. These roles aren't widely represented in healthcare workforce projections, or regularly suggested as options by leaders in STEM education. The US Bureau of Labor & Statistics doesn't even recognize clinical trial professions in its statistics.

This resulted in an overall lack of awareness of clinical research as a career option and little public understanding of what the positions entail, which deters people from entering the field and leads to high levels of churn. Most clinical trial data managers enter the job by chance, often without even knowing what's involved in their new role. Turnover rates for clinical research associates hover around 30%, which exacerbates the burden on remaining staff, leading to increased stress, burnout, and further attrition.

The COVID-19 Effect

Like so many problems in the workforce, this one was compounded by COVID-19. The "Great Resignation," in which older workers took early retirement due to pandemic-related health issues and/or a dislike of remote working, affected the clinical trials industry too.

Between Q1 2021 and Q1 2022, workers aged 40-60 years retired at exceptionally high rates, as the industry lost its most knowledgeable and valuable employees. Resignation rates among employees with 5-10 years of experience increased by 60% from 2020 to 2021, and by 55% among those with 10-15 years of experience.

More Data, More Problems

It doesn't help that much of the work carried out by trial staff is tedious and time-consuming. Data transfer between a medical center's electronic health records (EHR) and the sponsor's clinical trial database—and subsequent data verification—is still mostly manual. The typical trial involves multiple different systems, technologies, and communication tools, forcing employees to master many solutions and constantly switch between different platforms. This causes "app fatigue," which adds to employee frustration.

Regulatory bodies keep pushing for more data, and more sophisticated scientific assets make it possible to collect and crunch bigger datasets. But raising the data volume without increasing the number of trial staff available to process it inevitably leads to faster burnout and higher turnover rates.

The pressure on clinical trial professionals, particularly CRAs and CRCs, has only intensified since COVID-19. Both jobs are complex, arduous, and demanding, often requiring long hours of mind-numbing manual data copying and validation, and the data burden keeps growing. In the past decade, the volume of data gathered in Phase III oncology trials increased threefold to an average of 3.5 million data points.

Potential Solutions

Fortunately, there are ways to resolve the clinical trial staffing crisis. Introducing new tech like electronic data capture systems, which effortlessly stream data from EHRs to the sponsor's trial database, would cut the time effort involved in transferring and verifying data. Employees would no longer need to manually copy data from one screen to another, reducing burnout, minimizing errors, and freeing up time for tasks that can't be automated.

Without the tedium of manual data entry, clinical trial roles would also become more attractive to jobseekers. But it needs more than that to fix the talent pipeline. Universities and hospitals have to work together to establish global standards for training and qualification, and create a strong and clear professional identity for clinical trial personnel.

Gaining wider recognition of clinical trial positions, through bodies such as the US Bureau of Labor & Statistics, will also boost awareness of them as a valuable and viable career path. There also needs to be a concerted effort to improve career development opportunities, compensation, and job satisfaction for CRPs to improve retention, including greater collaboration with and engagement from PIs.

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 it's not irreversible. 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.

About the Author

Iddo Peleg is CEO and cofounder at Yonalink.