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Starting a cancer trial in ten countries means ten applications and ten ethics reviews. One shared application and a common ethics template would start trials months sooner.
The EU's Clinical Trials Information System allows a single application across member states. The proposal is to extend the same logic internationally: a common application dataset (protocol, IMP dossier, investigator brochure, consent template) accepted by FDA, MHRA, PMDA, NMPA, TGA and Health Canada with country-specific fields limited to sites and local consent language, and a harmonised ethics review template built on CIOMS and WHO guidance. Multiregional oncology trials would gain months per country.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions, Trials enrol too few, too slowly.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Trials enrol too few, too slowly.
Shares EU Clinical Trials Register / CTIS, Regulatory divergence between regions, Trials enrol too few, too slowly.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
Shares ClinicalTrials.gov, Regulatory divergence between regions.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Trials enrol too few, too slowly.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
Shares Regulatory divergence between regions, Trials enrol too few, too slowly.
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