A global first-in-human network for academic cancer trials with single ethics review
Academic first-in-human trials recruit slowly because each hospital repeats ethics and regulatory review. A network of phase 1 units with one shared review would open trials in many countries at once.
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.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
Pages like this
not linked directly; found by shared links- IdeaA mandatory trial line in every tumour board recommendation
Shares The Royal Marsden, Gustave Roussy, Trials enrol too few, too slowly, Memorial Sloan Kettering Cancer Center.
- IdeaHospital-exemption cell therapies at scale, backed by a shared registry
Shares A public indemnity pool so universities can sponsor first-in-human cancer trials, Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product, Regulatory divergence between regions.
- IdeaMutual recognition of ethics review across countries
Shares EORTC, Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaTrial-in-a-box: a preconfigured protocol kit any hospital can open for a rare cancer
Shares EORTC, Basket, umbrella, and platform trials, Trials enrol too few, too slowly.
- IdeaOne global rare cancer network with n-of-1 and Bayesian trial frameworks
Shares EORTC, Basket, umbrella, and platform trials, Regulatory divergence between regions.
- IdeaDrop the 'must speak English' rule: translated consent and questionnaires as standard
Shares EORTC, Trials enrol too few, too slowly.
- InstitutionInstitut National du Cancer
Shares Gustave Roussy, Basket, umbrella, and platform trials, Trials enrol too few, too slowly.
- Key paperReproducibility Project: Cancer Biology found that landmark preclinical results mostly shrank or vanished on replication
Shares A national non-profit contract research organisation for academic oncology trials, The valley of death between lab and product.