# One clinical trial application accepted by regulators in every major region

Source: https://onco.cc/ideas/idea-reg-global-trial-application-portal/  
OnCo record `idea-reg-global-trial-application-portal` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/), [EU Clinical Trials Register / CTIS](https://onco.cc/collections/eudract-ctis/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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