ideasIdea
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.
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.
What would test it
Pilot with one international academic platform under CTIS plus MHRA and one US single IRB; time arm openings before and after.
Maturity
early clinical
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- 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.