Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns. They unpacks two major red flags: High Prescribers – Is the KOL being compensated for research or for prescribing power? Influencer Effect – Are they being used to sway other physicians’ prescribing behavior? They also highlight issues with KOL selection based on outdated reputation or academic status rather than real-time operational capacity. Choosing the wrong KOL—one who can’t meet documentation or compliance standards—can derail your site’s performance. Key takeaway: Don't focus on titles—focus on capability, compliance, and fit. Avoid the label "KOL" and instead qualify experts based on their patient databases, research experience, and operational readiness. Like, comment, or reach out via LinkedIn. Support the show www.kulkarnilawfirm.com
