What is clinical trial liability insurance?

Clinical trial liability responds to claims from study subjects who suffer bodily injury, illness, or death as a result of participation in an investigational drug, biologic, or device trial. Covered scope includes both first-in-human studies and post-approval studies (Phase IV / observational), though carrier appetite and pricing vary substantially across phase.

Coverage typically includes no-fault patient injury for protocol-related injuries (whether or not negligence is established), defense costs in subject lawsuits, and indemnification of investigators and sites named as additional insureds under the sponsor's policy.

First-in-human studies of irreversible interventions (cell therapy, gene therapy, neurosurgical devices) typically require $5M-$10M per trial sponsor-side. Cell and gene therapy trials with FDA-mandated long-term follow-up registries require extended reporting period coverage through registry close - often 5-15 years post-dosing.

Multi-site international trials require coverage that satisfies each country's local insurance regulatory regime - many EU countries require admitted-paper local policies, which adds complexity and cost beyond US-only programs.