How to Run Country Feasibility for a Multi-Country Trial

Country feasibility answers one question: where can this protocol be delivered on time with the patients it needs. A structured approach keeps the decision objective.

What feasibility should cover

Patient availability, local standard of care and how it compares with the protocol.
Investigator interest, experience and capacity at each candidate site.
Competing studies in the same indication and their effect on recruitment.
Regulatory and ethics route, translation needs and investigational product logistics.

Data to collect from sites

Number of eligible patients seen per year, and how patients would be identified.
Equipment, laboratory and pharmacy capabilities needed for the protocol.
Staffing, other ongoing trials and the time needed for contracts and approvals.

How to compare countries

Score countries on the same criteria, and weigh each criterion according to your protocol.
Combine countries with different strengths, for example EU countries using CTIS and non-EU countries with national procedures, to spread risk.
Revisit the plan if enrolment lags, and add or replace sites early.

Common mistakes

Using optimistic enrolment estimates from a single investigator.
Ignoring competing trials or seasonal effects.
Leaving import, labelling and storage questions until after approval.

Discuss your study

Share your protocol synopsis and target countries, and we will respond with a feasibility view.

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