Staffing Shortages Are Hindering Clinical Trial Completion
Just as in the healthcare field overall, clinical researchers also are facing severe staffing shortages. “There are many anecdotes from across the country about how hiring and retaining clinical research staff has become very challenging since the pandemic, but not a lot of published data on how significant of an issue it is,” says Don S. Dizon, MD, FACP, FASCO, professor of medicine and surgery at Brown University.
Dizon and colleagues surveyed clinical research associates at the SWOG Cancer Research Network (part of the National Clinical Trials Network for the National Cancer Institute). More than 80% of oncology research programs reported personnel shortages.1 “This led to negative impacts on nearly all aspects of clinical trials operations,” Dizon notes. Half of respondents stated understaffing negatively affected IRB processes. Financial and legal review, along with the ability to conduct study audits and to accrue to trials, all were hindered. “All of this has limited the capacity of clinical researchers to optimally conduct clinical trials,” Dizon says.
That means delays in researchers offering novel treatments to people who are searching for clinical trials. “Clinical trials should always be an option for all who are looking for them, but access remains unequal due to a whole host of issues,” Dizon laments.
Now, staffing shortages are causing delays in studies opening for enrollment and (sometimes) early closure of those studies. “Sites are forced to adapt to a more challenging environment to conduct studies safely and properly,” Dizon concludes.
Staff turnover rates and lack of experienced staff are causing many studies to be delayed or postponed, according to the Society for Clinical Research Sites. “It has caused some sites to decline new studies,” reports Marissa Hill, communications manager for the group.
When research staff leave, “the first and foremost attention is on the capacity to do the upcoming safety visits for currently enrolled patients,” says Hill, adding that if staff cannot accomplish this task, parents may have to be dropped from those studies.
Some sites are curtailing new enrollment across all studies, or at least for studies that are not as economically sustainable as others. “It can take time to recruit new research staff. New hires need training and oversight,” Hill adds.
Sites estimate the average added cost to recruit and train a new patient-facing staff member is approximately six months pay. Due to the limited availability of qualified research staff, sites are replacing research coordinators with individuals without clinical research experience. “This skills gap makes these candidates more expensive to train and oversee,” Hill says.
It takes 10 to 20 weeks before new staff can function somewhat independently, and six months to one year before they are fully productive (i.e., at a capacity equivalent to their predecessor) in recruiting and coordinating existing studies. “This further diminishes the site’s capacity for enrollment and new studies,” Hill notes.
Additionally, salaries and benefits for new hires often cost substantially more, which may be unfeasible for sites based on current budgets. “Clinical trial sites are part of the supply chain for new medical diagnostics and therapeutics,” Hill says. If sites are operating at only a fraction of capacity, this means longer time to move products to market. This means people must wait months longer before medicines that could alleviate suffering can be tested and approved.
There also are intangible costs, such as the lost retention of currently enrolled participants. “A close relationship with their research coordinator is a major motivating factor for protocol compliance and continuance,” Hill explains.
Generally, clinical research coordinators are the primary source of recruitment. If that role is not filled, “sites, sponsors, and clinical research organizations need to pivot,” Hill says.
One solution is to accept people with academic degrees in research management or related experience in other disciplines, such as project management in non-life science areas or data analytics, as sufficient for entry-level duties.
Looking forward, workforce development programs are needed as “on ramps” to recruit more people into the clinical research profession. “We have already seen some organizations starting this,” Hill reports.
At UC Davis Health School of Medicine, a 16-week clinical research coordinator training program was developed. The overall goal, says Hill, is “to ensure the durability of sites to continue to deliver reliable study conduct and patient care.”
(Editor’s Note: For many more resources on how to manage staffing shortages, please consider reading the December 2022 edition of our sister publication, ED Management.)
1. Dizon DS, Szczepanek CM, Petrylak DP, et al. National impact of the COVID-19 pandemic on clinical trial staff attrition: Results of the SWOG Cancer Research Network survey of oncology research professionals. J Clin Oncol 2022;40:Suppl 11049.
Some sites are curtailing new enrollment across all studies, or at least for studies that are not as economically sustainable as others. Sites estimate the average added cost to recruit and train a new patient-facing staff member is approximately six months pay. Due to the limited availability of qualified research staff, sites are replacing research coordinators with individuals without clinical research experience.
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