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They also highlight issues with KOL selection based on outdated reputation or academic status rather than real-time operational capacity.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.
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