How much clinical trial insurance does a gene therapy trial need?

Gene therapy sits at the top of the clinical trial liability range. The intervention is usually irreversible, the mechanism is novel, and the populations are frequently rare-disease, pediatric, or otherwise vulnerable - each of which raises both the required limit and the underwriting scrutiny. First-in-human and pivotal gene-therapy trials commonly require $10M-$25M or more, and multi-country or oncology gene-therapy programs push higher.

Many programs carry both an aggregate limit for the whole trial and a per-subject (per-claimant) sub-limit, set so a single catastrophic injury can be funded without exhausting the aggregate that protects the rest of the cohort. Ethics committees and, in some countries, national regulators review the insurance and subject-compensation arrangements before enrollment, and inadequate limits can hold up approval.

The controlling number is what the clinical trial agreement, the IRB or ethics committee, and any applicable national law specify for the specific study - the ranges above are practitioner-typical, not a formula. And because the coverage is claims-made and the follow-up window is long, sizing the limit without planning the tail is the common miss.