ideasIdea
Mutual recognition of ethics review across countries
A trial approved by a qualified ethics committee in one country would not need to repeat the full review in another; the second country would accept the first review and check only local issues.
Building on the EU Clinical Trials Regulation single-assessment model and the US single-IRB requirement, a treaty or regulatory reliance agreement would allow ethics committees in participating countries (EU, UK, Switzerland, Canada, Australia, Japan) to rely on a lead committee's scientific and ethical assessment, with local review limited to consent language, insurance and site suitability.
Hypothesis
Multinational oncology trials in participating countries will start enrolment 2-4 months earlier in second and later countries, and more small countries will be included in pivotal trials.
Rationale
Regulatory reliance already works for drug approvals (Access Consortium, Project Orbis). Duplicate ethics review rarely changes a protocol but routinely delays it.
What would test it
Pilot reliance between two willing jurisdictions for cooperative-group trials; measure time from lead approval to first patient in the second country compared with matched historical trials.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
4
Bottlenecks it attacks
- 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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.