Open Letter to Sponsor and CRO Colleagues Regarding the Workforce Retention and Inflationary Pressures Affecting Clinical Trial Sites

To Our Esteemed Sponsor and CRO Partners:

As our industry undergoes rapid change and transformation, sites are experiencing unforeseen, unprecedented, and historic increases in costs centered around patient-facing research staff and overhead. Many careered site professionals have shared the negative impact industry recruitment and staff attrition have had on site capabilities to conduct studies.

Regarding the workforce challenges, SCRS interviewed several of its largest site networks. The stories were so concerning that an SCRS Task Force was formed immediately to share some insights and a call to action for the collective clinical research industry.

 

Patient-Facing Staff Turnover:

The collective feedback SCRS has received from many sites indicates that the current turnover rate of patient-facing staff is much higher than in previous years. Site networks are averaging double the usual turnover rate of patient-facing staff from a range of 10% – 37% pre-crisis to current rates of 35% – 61%. This is due to many factors such as:

 

• “The Great Resignation” in general, exacerbated by increasing costs of living rising at historic rates.
• Site staff recruited by companies (including Sponsors and CROs) that offer lucrative sign-on (and “refer a colleague”) bonuses, as well as compensation packages much higher than existing clinical trial budgets allow for at the site level.

The recruitment of site staff to Sponsors, CROs and other organizations is having a significant impact on the performance of studies. With this trend of movement of staff away from sites, Sponsors are beginning to experience the negative impact staff turnover has on study management.

 

Patient-Facing Staff Turnover Direct Costs:

Sites estimate their average added cost to recruit and train a new patient-facing staff member is approximately 6-months pay. Sites usually must replace research coordinators with individuals without clinical research experience. This skills gap makes these candidates more expensive to train and oversee. Sites estimate that it takes approximately 10 – 20 weeks to go through the hiring and onboarding process for new patient-facing staff to be able to function quasi-independently, and anywhere from 6 -12 months before they are as fully productive at a capacity equivalent to their predecessor in recruiting and coordinating the existing studies.

When a patient-facing employee exits, the curtailment of new enrollment is a loss of revenue to the site. This issue is further challenged by patient-facing staff providing less than the customary 2-4 weeks’ notice when their new employer uses a “start immediately” bonus incentive. Not only does this rapid incentive add to the time for recruitment of a replacement, but it also lessens the opportunity for that new employee to be trained by an outgoing employee with experience. Potentially the most important intangible cost is the lost engagement and/or retention of currently enrolled participants in the clinical trial who have such a close relationship with their research coordinator as a major motivating factor for protocol compliance and continuance.

 

Increase in Overhead:

Pressures on sites due to overhead costs are continuing to increase significantly from as recently as one year ago. Factors driving overhead cost increases include:

 

• Turnover-related issues: employee recognition software, increases in quality assurance/improvement resources to manage turnover especially due to the increased percentage of new hires who are industry naïve.
• Post-COVID rises in operational costs increases in physical plant costs for infection prevention and increases in disposable PPE.
• General inflationary pressures: with the U.S. Bureau of Labor Statistics measuring current inflation rates at 8.5%/annually, this means prices are rising at a rate of 5 times higher than the last decade’s average of 1.7%/annually. It is very important to note that the cost of living consideration has yet to impact sites that may not have repurchased depleted supplies yet or are awaiting renewal of annual/bi-annual contracts.

The SCRS Task Force estimates sites’ overhead costs in the next 6-18 months will continue increasing at unprecedented rates. With inflation rates at a 40+ year high, extra attention must be given to payment frequency.

A monthly payment frequency allows for timely cash flow around study operations. Quarterly payments or the practice of holdbacks (a percent of the site’s needed funds until the end of the study) will create substantial barriers to study success. Sites are also seeing increased delays in scheduled payments at any frequency, which is an impediment to the cash flow sites need to optimally conduct a CRO/Sponsor’s study.

In addition, many study budgets do not have cost of living adjustments in their payment terms, with sites locked into fees/rates that are unsustainable even as soon as 1 to 2 years in the future.

 

Critical Call-to-Action:

 

1. Dialogue with Sites: SCRS recommends an open dialogue with individual sites to learn more about the macroeconomic pressures affecting the conduct of your studies and to work together creatively to improve resources and/or take away burdens so that sites can successfully continue current and future studies.
2. Invest: An important path to site sustainability includes Sponsors and CROs embracing renegotiation of existing budgets to sustain prior efforts of recruitment, retention, and quality until the industry reaches a steady, more predictable state of cost increases. Without bringing these kinds of payment terms to sustainable levels, sites will have to divert more resources to cash management and finance. These resources could otherwise be used for additional recruitment, retention, and quality efforts. Invest in considering appropriate payment for sites related to the industry challenge posed.
3. Explore experience: Be creative at sourcing employees from non-site sources. Over the past few years, several large Sponsors have successfully piloted accepting academic degrees in research management, internships, related experience in other disciplines (e.g., project management in non-life science areas), data analytics/management, and other experience as sufficient for entry-level duties. Help the industry build a much more expanded applicant pool and reduce focus on a site’s clinical research coordinators (CRCs) as the primary source of recruitment.

 

Coming Together to Provide Solutions:

SCRS understands and respects that most industry organizations are also feeling macroeconomic pressures of staff turnover and increased costs. The overall mission of the SCRS Task Force is to educate sites on best practices in recruiting and retaining their staff as well as on best practices in cost management.

However, even the most experienced sites are stating that we cannot solve this as a site industry alone and need the resources and assistance from our Sponsor and CRO colleagues. When our sites are suffering, our studies are suffering. By working together, we can ensure the durability of sites to continue to deliver reliable study conduct and patient care.

For more large-scale solutions or dialogue, SCRS stands ready to facilitate these opportunities with its partners and site members. Look for future programming opportunities to be announced. Do not hesitate to reach out to info@myscrs.org to discuss this issue further and/or explore solutions with SCRS and our site community.