{"entity":{"id":"idea-reg-global-trial-application-portal","kind":"idea","name":"One clinical trial application accepted by regulators in every major region","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis"}],"tags":[],"related":["eudract-ctis","clinicaltrials-gov"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A shared application dataset cuts the median time from first to last country activation in multiregional oncology phase 3 trials by at least four months and reduces sponsor start-up cost per country by half.","rationale":"Country start-up is the largest single contributor to trial duration variance. The scientific content of applications is identical; only the forms differ. CTIS shows that a shared system works across 27 legal systems.","test":"Pilot with ICH members on ten multiregional oncology trials using a common application dataset; measure first-to-last activation interval against the sponsors' own historical benchmarks.","maturity":"speculative","actor":"regulator","cost":"medium","horizonYears":5},"route":"/ideas/idea-reg-global-trial-application-portal/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"eudract-ctis","kind":"collection","name":"EU Clinical Trials Register / CTIS","route":"/collections/eudract-ctis/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}