One ethics approval and one consent form for a platform trial across countries
Adding a new arm to an international platform trial currently needs approval in every country again. A single, pre-agreed process would let arms open in weeks.
The EU Clinical Trials Regulation and its CTIS portal, the US single IRB mandate and the UK combined review are steps towards this, but arm additions to platforms still trigger substantial amendments reviewed separately. A recognised 'platform amendment' pathway with pre-approved master consent language and a 30-day review clock for new arms would make international platforms practical.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaOne clinical trial application accepted by regulators in every major region
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
- IdeaOne national master contract and budget template for all cancer trials
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
- IdeaPublish why patients were screened out of each trial
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaShared concurrent control arms across sponsors' trials in the same setting
Shares ClinicalTrials.gov, Basket, umbrella, and platform trials, Too many combinations to test.
- IdeaMutual recognition of ethics review across countries
Shares EU Clinical Trials Register / CTIS, 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.
- IdeaA plain-language summary of every cancer trial result within a year
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaAn open forecasting tournament on which combination trials will succeed