By Marissa Hill, communications manager, Society for Clinical Research Sites
As the industry faces unprecedented macroeconomic issues, including substantial staffing challenges and inflationary pressures, resources are desperately needed to support clinical research sites and studies.
SCRS has heard from several sites that are concerned about staff turnover and the inflationary pressures affecting their business. To help address these challenges, SCRS established a Task Force that provides best practices and collaborative solutions for both sites and industry to navigate some of the most critical issues in clinical research right now.
The Task Force committee is composed of some of SCRS’ largest site network members and has already distributed several deliverables, including a site toolkit and open letter to industry partners.
The idea for the Task Force came at the beginning of this year when William Smith, CEO of Alliance Multispecialty Research, was looking at trends and turnover among his site staff, as well as the inflation and projections around their cost structure for the year. In discussions with other sites, it was clear that many of them were facing the same challenges and were unsure how to move forward to ensure their sustainability. “We felt that one-on-one discussions with sponsors and CROs would not be as productive as a group discussion hosted by SCRS,” commented Smith.
That’s exactly why the Task Force was created – to collectively represent the site voice, outline challenges sites are facing, and encourage sponsor and CRO partners to start a dialogue with sites to address these issues.
Tools For Sites
A site toolkit has been developed to aid sites in managing costs, negotiating, and retaining staff, for starters. Many of SCRS’ largest site network members contributed ideas and best practices to the toolkit. “We have an ethical obligation to solve what we can on our own,” said David Vulcano, SCRS honorary president and VP of clinical research compliance & integrity at HCA Healthcare.
One particularly helpful area of the toolkit targets minimizing staff onboarding costs and helps with ideas to bring site staff on board while minimizing delays. There is also advice to help ensure new staff are adequately trained and that they’re able to execute studies with minimal errors.
Managing Site Cash Flow And Staffing Challenges
As site costs increase with inflation, cash flow is becoming a significant issue. The site toolkit discusses how to manage costs, negotiate for monthly payments, and plan for cash flow disruptions. The goal is to provide sites with best practices and strategies to make sure they can survive the current economic environment as successfully as possible.
Understanding the current rate of inflation and its impact on budgets for multiyear studies is especially important right now. What sites charge for certain line items this year should not be the same as what they charge in the following years.
Jeff Kingsley, CEO of Centricity Research and SCRS Task Force member, added, “Inflation increased substantially, which means our cash flow is going to be negatively impacted today and into the future. We're bound by contracts today that were negotiated before. Contracts that we negotiate tomorrow will be more aggressive because we know the inflationary environment we're in today. But sites are going to suffer in between.”
Site Staff Turnover
With the current rates of staff turnover, site staff who had long-standing relationships with trial subjects may no longer be there. Turnover doesn’t just impact sites – more importantly, it impacts the subjects and their willingness to begin or continue trials. Clinical trial participants are also being affected by macroeconomic pressures, such as heightened transportation costs.
Smith commented, “It’s much more than the financial health of the sites. It’s our ability to enroll. It also affects our ability to retain these subjects and to make clinical trials a positive experience.”
With the lack of talent options available in all sectors of clinical research, it is becoming more common for CROs to recruit coordinators from their studies. Normally, this may not be an issue if adequate or extended notice is provided, but some CROs have provided recruits incentives to start immediately. This practice often leaves sites scrambling to find, onboard, and train new staff quickly. SCRS suggests that if industry partners need to recruit site staff to work for their organizations, there should be some sort of study continuity plan negotiated with the site.
“The industry is desperate for people. CROs need more CRAs, as an example, and so they recruit a site coordinator, but it's not in the best interest of our industry. Sites are having to replace those people. It's concerning when an experienced clinical research coordinator leaves a site to become a CRA, because the quality of the data at the site level is greatly impacted by having novice staff,” said Kingsley.
Impact Of Employee Turnover On Site Success
Everyone in the clinical research industry can create errors. But meaningful errors that contribute to trial failures, such as participant qualifications and protocol deviations, all happen at the site. Fundamentally, reducing errors at the site should be everyone's focus. Kingsley commented that with novice coordinators, enrollment may not be as strong as with an experienced coordinator, and error rates may be higher.
Kingsley shared, “It takes, in my opinion, at least a year for a coordinator to get their feet underneath them. The same is true of investigators and other roles at sites. It takes a great deal of experience to begin to understand what you're doing, why you're doing it, the nuances, the fine details.”
Smith added, “In addition to the loss of efficiency that we see with staff turnover and training new people, it also requires a lot more time from the PI to do effective oversight because new employees are more at risk for mistakes. You must be much more involved. You must spend more time answering questions, educating them.”
Monitors from the sponsors and CROs have also experienced similar turnover, which means many of the monitors are less experienced as well. It can take significantly more investigator time when interacting with monitors and vendors.
Research has shown that certified coordinators and principal investigators produce better enrollment and fewer errors and get fewer 483s. Will the inverse be true with the current level of site staff turnover?
When a site loses a coordinator, one of the first impacts is the site may no longer have the capacity to conduct upcoming safety visits. The site may look at removing the subjects from the study. Second, the trial subjects may withdraw on their own if they were close to their study coordinator. Many times, subjects have a strong relationship with the coordinators they have been working with, and when they lose that personal connection it’s one less motivating factor to continue the study. Additionally, sites may need to halt enrollment in studies because they may not have the staff to manage it.
What can the clinical trials industry do to retain top talent? Some of the ideas outlined in the toolkit include conducting salary surveys, revisiting benefits, establishing culture committees, and practicing employee career mapping. The toolkit also shares how to onboard employees quickly to set site teams up for success.
A Call To Action For Sponsors And CROs
The open letter created by the SCRS Task Force suggests sponsors and CROs should be open to respectful and honest dialogue about these economic pressures and staffing concerns. Consider ways to help sites right now: Can existing budgets be adjusted? If not, what other solutions may be available?
Traditionally, industry partners might push back on sites by saying current rates are not fair market value. However, rates from one year ago, or even a few months ago, are not applicable today. Sites are paying higher fees for staff and supplies already.
When negotiating, we are encouraging sites to share supporting documentation whenever possible and provide examples showing increased costs. SCRS also encourages sharing or referencing the open letter drafted by the Task Force as additional support.
Smith added that his site is working toward renegotiations right now, saying “We are currently in the process of refining some of our increased costs. We plan to send the SCRS open letter with a cover letter to discuss issues that are more specific to our sites and ask for help.”
It’s important to acknowledge this isn’t happening in just one area of the country or world, and it’s not isolated to certain types of sites. It’s happening to sites of all types and sizes. The industry is in this together, but we need to ensure conversations are happening and action is underway.
Continuing The Conversation
Sponsors and CROs have expressed to SCRS that they want to hear from sites, because when sites are suffering, studies suffer, and that impacts all the work we do as an industry.
Kingsley suggests that sponsors and CROs need to understand that the current situation is not sustainable. Industry must view sites as a partner and help come up with solutions that will keep sites economically viable and keep their workforces stable. This will enable sites to participate in their clinical trials and for those trials to be successful.
“Be active. Make changes today aimed at reducing turnover, bringing new people in, and getting them up to speed as rapidly as possible,” Smith added.
The Task Force is planning several opportunities for continued dialogue between industry and sites. Learn more about the open letter to industry sponsors and CROs and the site toolkit available to SCRS member sites on the SCRS Task Force website.