Current Edition

Unlock Clinical Research Site Potential by Addressing Resource Challenges and Trial Complexity

Staffing and trial enrolment remain the most pressing issues research sites face, according to the 2023 WCG Clinical Research Site Challenges survey. As trial complexity increases and sites continue to struggle with resourcing, sites are having to do more with less. Despite these challenges, sites are finding innovative ways to move forward with help from sponsors, clinical research organisations (CROs), and other partners. All of this has the potential to reshape the future of clinical research.

About the Survey and the Results

In February-March 2023, WCG surveyed more than 500 US-based clinical research sites. The survey asked site leadership/owners, research administration staff, clinical research coordinators/ clinical research nurses, institutional review board/regulatory representatives, physicians/principal investigators, and others about their perspectives on the major challenges they are facing, solutions they have implemented to overcome those obstacles, and more. Thirty-nine percent of survey respondents represented academic medical centres (AMCs), and the remaining 61% represented non-academic research centres (non-AMCs) including community hospitals, health systems, physician practices, and independent research sites.

A Threat to Opening New Trials

According to the survey results, 63% of sites identified staffing and retention as their most significant concern, recruitment and enrolment was second at 48%, and trial complexity and study startup tied for third at 36%. To explore the implications of the survey findings, WCG convened representatives from a sponsor, an AMC, and a non-AMC for a discussion on its podcast, WCG Talks Trials. The episode featured:

• Lisa Richman Ballance – Associate Vice President for Research Strategy and Regulatory Affairs at Virginia Commonwealth University (VCU)

• John Musser – Senior Director, Clinical Research Administration at Florida Cancer Specialists & Research Institute

• Dan Otap – Principal, Alliance and Partnerships Lead at Genentech

• Sandy Smith, RN, MSN, AOCN – Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG

Smith pointed out that 52% of the respondents indicated that challenges they identified in the survey have had a direct impact on their site’s ability to open trials. WCG’s proprietary data supports this finding: in 2022, more than 3,300 US sites opened only one clinical trial, and fewer than 50 sites opened 50 or more trials.

“What surprised me most about that is that even running one trial…requires a lot of infrastructure,” Ballance said, expressing concern that this trend could lead to a decline in smaller sites.