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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.
Many exciting laboratory findings that motivate drug programmes are weaker or less reliable than published, which helps explain the high failure rate of drugs entering clinical trials. It argues for pre-registration, detailed methods, data sharing and independent replication before major translational investment.
One bottleneck page and twelve idea pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
Shares A public indemnity pool so universities can sponsor first-in-human cancer trials, Translational research: crossing the valley of death, Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product.
Shares Translational research: crossing the valley of death, Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product.
Shares Translational research: crossing the valley of death, The valley of death between lab and product, National Cancer Institute (NIH).
Shares EORTC, Trial design, endpoints and cost, National Cancer Institute (NIH).
Shares Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product, National Cancer Institute (NIH).
Shares Translational research: crossing the valley of death, The valley of death between lab and product.
Shares Translational research: crossing the valley of death, The valley of death between lab and product.
Shares Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product.