Big Budget Challenges Loom for Sites in 2021

Kelly Willenberg

Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates.

Next year promises “a rough road .for some sites” when it comes to budgeting and designing financial workflows to sustain operations, says Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, manager of Kelly Willenberg & Associates.

Willenberg is keeping a special eye on smaller sites and those that have entered the industry more recently to focus on COVID-19 trials. “It’s going to be interesting to see in the next few years which sites are sustainable, especially [in terms of] those who got into trials in the past six months or so,” she says.

Deena Bernstein, BA, MHS, senior vice president for network and partnerships with Circuit Clinical, agrees. “Once things settle down, and we see different types of trials [other than for COVID-19] emerge [again], it will be somewhat of a challenge for sites to operate and navigate trials that require different approaches and technologies,” Bernstein says. “These are good challenges to overcome as we become more aware of the considerations on how to become more efficient.”

Bernstein and Willenberg believe sites are going to be feeling the repercussions of the pandemic on their operations for years to come, with 2021 being especially complicated and fraught with peril. However, on the flip side, they say it has been an amazing year for innovation.

Things will go better for sites as long as there is awareness of the additional costs and “new line items” to consider in budgeting for COVID-19-era trials, Willenberg says. As an example, “I work with a site that recently had to purchase iPads for all its coordinators,” she notes. It was an unexpected expense, as were the personal protective equipment, extra time and training of staff, and other costs associated with hybrid or virtual trials, she adds.

“Virtual or hybrid trials can actually be more expensive for sites,” Bernstein says, in part because sites have to “be ready for all kinds of approaches.”

“Sites and sponsors don’t want to hear” that hybrid trials can be more costly for sites, but it’s the reality, Willenberg says. She adds that many sites are still struggling with cash flow issues precipitated by the steep decline in trial business beginning in April and running through at least June or July of this year.

Another issue for sites is how to budget for the inevitable “reeling in” by the U.S. Food and Drug Administration and other regulators as the trial landscape begins to calm down in 2021. Sites are looking at the prospect of future audits from regulators examining how they conducted themselves during the crisis months of 2020, Bernstein says.

“I’m getting calls now from sites who know they were putting out fires in 2020 and want to proactively go back and make certain they didn’t react incorrectly,” Willenberg says.

“We all had to pivot in how we work” because of the pandemic, Bernstein says, “and there will be unforeseen costs” to contend with as a result.

Author: Michael Causey