Study start-up & site selection

• Patient pathwaysEligibility translated into where such patients are actually found: prior lines of therapy, timing of biomarker testing, referral patterns and time-sensitive treatment decisions.
• Site capabilityInvestigator experience with the modality, imaging and pathology capacity, early-phase infrastructure, sample logistics and competing trials.
• Feasibility questionsQuestionnaires and investigator conversations designed to elicit realistic numbers rather than optimistic estimates.
• Country and region choicesDifferences in standard of care that affect comparator relevance and interpretability.
• Activation readinessSite training content, investigator-meeting priorities and early tracking of enrollment against assumptions.

A site with a strong reputation can still struggle with the exact population or procedures in a protocol. Enrollment shortfalls in oncology are often problems of population and pathway rather than effort, and finding that out after activation is slow and expensive.

Standard of care also differs between countries, which can change how relevant a comparator is and how the results will be read.

• Selecting countries and sitesfor a biomarker-defined or heavily pretreated population.
• Testing recruitment assumptionsbefore the protocol or budget is final.
• Reviewing a site listproposed by a CRO.
• Recovering a studythat is enrolling below plan.

1. Describe the patient Who qualifies, where they are treated and when the decisions that affect eligibility are made.
2. Test the assumptions Feasibility discussions with investigators and a review of the evidence behind projected enrollment.
3. Rank by fit Sites and countries assessed on capability for this protocol, not on name or past volume alone.
4. Prepare activation Training, early enrollment tracking and a short list of dependencies to clear.

• A clinically informed feasibility questionnaire and site-assessment framework
• A review of site capability and recruitment assumptions
• A prioritized readiness and dependency register
• Clinical input to site training and start-up discussions

• StructureA review of site strategy, clinical participation in feasibility discussions, or a defined start-up workstream alongside the sponsor and CRO.
• What we need from youThe protocol or concept, intended regions, a preliminary site list, any feasibility responses and what is known about the patient population.
• Roles and limitsCountry requirements, contracting, budgets and operational start-up are led by clinical-operations specialists. Recruitment projections remain assumptions and are revisited as data accrue.