ideasIdea
One clinical trial application accepted by regulators in every major region
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.
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.
What would test it
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
Who has to act
regulator
Cost to try
Medium ($1M to $50M)
Years to first evidence
5
Bottlenecks it attacks
- 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.