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Academic first-in-human cancer trials recruit slowly because each hospital repeats ethics and regulatory review. Twenty to thirty academic phase 1 units across Europe, North America and Asia would share protocol templates, one mutually recognised review, a joint safety committee and harmonised contracts, so a trial opens at every site within weeks and rare molecular subtypes can be pooled.
Twenty to thirty academic phase 1 oncology units across Europe, North America and Asia agree common protocols templates, a single mutually-recognised ethics and scientific review, a shared safety committee and harmonised contracts, so an academic first-in-human trial approved by the network opens at all sites within weeks. The EU Clinical Trials Regulation and US single-IRB rules already allow much of this; the missing part is an organisation that operates it for academic sponsors. The network also concentrates rare molecular subtypes and rare cancers, where single-site academic trials never accrue.
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 Gustave Roussy, The Royal Marsden, Trials enrol too few, too slowly, Memorial Sloan Kettering Cancer Center.
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 EORTC, Regulatory divergence between regions, Trials enrol too few, too slowly.
Shares EORTC, Basket, umbrella, and platform trials, Trials enrol too few, too slowly.
Shares Translational research: crossing the valley of death, The valley of death between lab and product.
Shares EORTC, Basket, umbrella, and platform trials, Regulatory divergence between regions.
Shares Translational research: crossing the valley of death, The valley of death between lab and product.