Experts Decipher New Clinical Trial Budgeting Challenges in 2021

The COVID-19 pandemic has upended the clinical trial landscape in ways large and small, agreed experts on the final day of the ACRP 2021 virtual conference’s January track (January 14). On the positive side, it showed the clinical trial workforce in a favorable new light—one in which professionals rose to the occasion, in part by adapting a new flexibility with technology and operations to produce several vaccines at warp speed.

However, it also put incredible pressure on the workforce, including making budgeting and billing issues even more complicated for sites. The situation is especially challenging for sites operating with limited cash flow and suspended or delayed trials.

“Be transparent and explain your site’s unique costs, procedures, logistics, and billing compliance,” Kelly Willenberg, owner of Kelly Willenberg & Associates, told attendees. “Provide explicit explanation and justification for requests to increase line items,” she added. “Sponsors are being very accommodating” during the COVID-19 crisis, Willenberg noted.

“Sites should talk to sponsors” and be clear about their needs, especially during these unusual times, agreed Kenny Kong, director of Life Sciences and Health IT at Exostar at a later session. He also advised clinical trial practitioners to find time for themselves and take much-needed breaks to avoid burnout. “Clinical trial practitioners have a lot to be proud of in 2020,” he added.

Further, much of this new technology and new ways of doing things in clinical trials is likely here to say, speakers said. “We’ve got a new world, and I don’t anticipate us ever going back [to how things used to be] 100%,” Willenberg said.

Surveying what she called a “new paradigm,” Deena Bernstein, senior vice president of Network and Partnerships at Circuit Clinical, said sites have a lot of new items to think about when it comes to budgeting for a trial in 2021, partially due to the increasing use of eConsent, remote technologies, and other components of decentralized clinical trials. Examples include:

  • New equipment requirements (e.g., freezers for COVID-19 vaccines)
  • Sanitizing workspaces
  • Purchasing personal protective equipment for staff and patients
  • Training expenses
  • COVID-19 testing for employees and patients

“Sites need to demonstrate more flexibility to retain patients” by offering them new ways to enroll and remain in clinical trials, Bernstein said.

Willenberg offered some “human factor” advice when working to negotiate trial budget terms. “Be courteous in e-mails and conversations, and avoid creating a combative environment,” she said.

A final piece of advice: “If you cannot come to mutually beneficial budget terms, don’t be afraid to walk away from the opportunity,” Willenberg said.

ACRP 2021 will return in May with a track on Operational Efficiencies and in September with a track on Regulatory Trends and Compliance.

Author: Michael Causey