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.
- 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.
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, Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaOne national master contract and budget template for all cancer trials
Shares EU Clinical Trials Register / CTIS, Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaPublish why patients were screened out of each trial
Shares EU Clinical Trials Register / CTIS, Trials enrol too few, too slowly.
- IdeaDrop the 'must speak English' rule: translated consent and questionnaires as standard
Shares EORTC, Trials enrol too few, too slowly.
- IdeaOne ethics approval and one consent form for a platform trial across countries
Shares EU Clinical Trials Register / CTIS, Regulatory divergence between regions.
- IdeaA global open trials operating system any hospital can plug into
Shares Trials enrol too few, too slowly, Regulatory divergence between regions.
- IdeaGuidelines list the open trials at every decision point, updated monthly
Shares European Society for Medical Oncology (ESMO), Trials enrol too few, too slowly.
- IdeaTrial-in-a-box: a preconfigured protocol kit any hospital can open for a rare cancer
Shares EORTC, Trials enrol too few, too slowly.