Beyond KOLs: Involving All Stakeholders In The Recruitment Process

Patient recruitment remains a formidable hurdle for clinical trial sponsors, with up to 86% of trials failing to meet recruitment targets within stipulated time frames. This challenge not only hampers study progress but also has the potential to double intended enrollment periods. In a recent webinar by Citeline/Clinical Leader titled "Unlock Clinical Trial Enrollment ROI," experts delved into the complexities of patient recruitment and proposed strategies to address them.

Ted Trafford, Director of Business Development at Probity Medical Research, a clinical trial consortium spanning five countries, highlighted a critical factor influencing recruitment—the development of the study protocol. He emphasized the need to enhance protocols from a site perspective, noting that relying solely on key opinion leaders (KOLs) for guidance might be limiting. While KOLs contribute disease area expertise, they may lack insights into the operational challenges faced by recruiting sites.

Trafford proposed a shift towards engaging experienced study coordinators and investigators early in the program, starting before Phase II and continuing through Phase III. He advocated for the inclusion of high-performing sites and patient groups in advisory boards, fostering ongoing discussions to address recruitment challenges in specific indications. This proactive approach, he believes, ensures a more dynamic and responsive strategy, adapting to the rapidly changing landscape of clinical trials.