FNL clinical research professionals help boost enrollment, productivity for NCI-sponsored clinical trials via novel virtual initiative

Virtual support from Frederick National Laboratory for Cancer Research (FNL) clinical research professionals helps on-site staff at U.S. cancer centers boost enrollment for National Cancer Institute-sponsored clinical trials. 

Image

The Virtual Clinical Trials Office (VCTO), staffed by FNL’s Clinical Monitoring Research Program Directorate (CMRPD), screens patients and provides data management support.

The NCI Division of Cancer Treatment and Diagnosis (DCTD) established the virtual workforce initiative to increase enrollment and address the clinical research professionals staffing shortage compounded by the COVID-19 pandemic.  

According to DCTD’s Michael Montello, Pharm.D., the goal of the VCTO is to address staffing shortages at NCI clinical trial network sites to promote improved patient access to novel cancer therapies. 

“The pilot is still in its early stages, but to date the results show great promise,” Montello said.  

The FNL team supports 11 clinical sites nationwide conducting cancer control and prevention protocols and cancer treatment trials. 

“We staff our team with clinical research professionals who have experience in onsite study coordination, sponsor monitoring, and auditing,” said Elaine Kulm, a CMRPD nurse administrator. “They have walked in the shoes of those they support.” 

Early efforts lead to an increase in patient enrollment 

The VCTO launched in September 2022, and as of December 2024, the CMRPD virtual team helped enroll 85 clinical trial participants across the 11 sites.  

Most sites have the capacity to screen new referrals, new diagnoses, and relapses, Kulm said. The VCTO provides sites where the capacity to screen patients who are undergoing treatment for cancer and may be eligible for a study. VCTO aims to improve clinical trial access for patients, particularly in minority and underserved communities, and to improve the inclusivity of research data and outcomes.   

“We are assisting sites with the identification of patients who are receiving treatment and may qualify for a trial,” said Clinical Project Manager Christen Osburn. “This screening capacity is often limited at sites. This intervention could have an amazing impact on the lives of patients.” 

In addition to increasing patient enrollment at the participating sites, the FNL team is charged with expanding support to more sites and protocols. 

A new way of working 

Patient accrual and data collection and analysis are the operational onus for any clinical trial. Providing participating sites with access to virtual staff support helps alleviate this burden.  

Staff at the participating sites and their FNL support team agree that the virtual model can upend the traditional way to manage a clinical trial.  

“It’s difficult to hand off responsibilities to conduct your clinical trial to someone you’ve met on screen," Kulm said. "The VCTO team works hard to build trust with the study teams at the supported sites." 

FNL team members share their collective clinical research experience to improve workflow processes and foster a collaborative relationship with on-site staff. Their problem-solving and relationship-building skills are paying off. A year into the program, site staff tell the VCTO team that they wish they had this level of support earlier. 

Well-suited for clinical trial support 

The CMRPD has a long history of supporting global clinical research programs conducted by the National Institutes of Health (NIH). Their ability to quickly launch clinical trials at home and abroad hasn’t gone unrecognized by NIH or NCI.  

“They look at our collection of work and acknowledge we know how to hire the right staff, think creatively, and navigate uncharted waters,” said CMRPD Director Shelly Simpson.