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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.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Regulatory divergence between regions.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
Shares ClinicalTrials.gov, Basket, umbrella, and platform trials, Too many combinations to test.
Shares EU Clinical Trials Register / CTIS, Regulatory divergence between regions.
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
Shares Basket, umbrella, and platform trials, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Too many combinations to test.
Shares ClinicalTrials.gov, Regulatory divergence between regions.