{"entity":{"id":"idea-tr2-platform-single-ethics","kind":"idea","name":"One ethics approval and one consent form for a platform trial across countries","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"EU Clinical Trials Information System","url":"https://euclinicaltrials.eu/"}],"tags":[],"related":["eudract-ctis","clinicaltrials-gov"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["basket-umbrella-platform"],"trials":[],"people":[],"bottlenecks":["b-combination-space","b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A dedicated platform amendment pathway reduces median time to open a new arm across five countries from over twelve months to under three.","rationale":"The adaptive platform trial community has documented arm-opening delays as the main limit on throughput. Regulatory harmonisation initiatives (ICH E6(R3), Project Orbis) show that reviewers can share work.","test":"Pilot with one international academic platform under CTIS plus MHRA and one US single IRB; time arm openings before and after.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-tr2-platform-single-ethics/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"eudract-ctis","kind":"collection","name":"EU Clinical Trials Register / CTIS","route":"/collections/eudract-ctis/"}],"term":[{"id":"basket-umbrella-platform","kind":"term","name":"Basket, umbrella, and platform trials","route":"/terms/basket-umbrella-platform/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"}],"roadmap":[{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}