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.
- 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- IdeaOne national master contract and budget template for all cancer trials
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaPublish why patients were screened out of each trial
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Trials enrol too few, too slowly.
- IdeaOne ethics approval and one consent form for a platform trial across countries
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
- IdeaMutual recognition of ethics review across countries
Shares EU Clinical Trials Register / CTIS, Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaLive tracker of the lag from first approval to real availability in every country
Shares ClinicalTrials.gov, Regulatory divergence between regions.
- IdeaPay investigators for finishing and publishing trials, not for enrolling patients
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Trials enrol too few, too slowly.
- IdeaA global open trials operating system any hospital can plug into
Shares Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaA plain-language summary of every cancer trial result within a year
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.