A national non-profit contract research organisation for academic oncology trials
Running an early trial properly requires monitors, data managers, safety reporting and regulatory filings that universities cannot afford from commercial providers. A public not-for-profit would do this work at cost.
A publicly-owned or non-profit CRO providing sponsor-level services (protocol development, regulatory submissions, monitoring, pharmacovigilance, data management, statistics) to academic phase 1 and 2 oncology trials at cost, funded partly by a core grant and partly by fees charged to grants. Academic trials fail or stall for operational, not scientific, reasons; commercial CRO fees consume a large share of academic trial budgets. Precedents include the UK's NIHR clinical research network infrastructure, the EORTC headquarters model for European academic trials, and NCI's CTEP for investigational agents.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.