Feasibility assessment represents the critical first step in clinical trial planning, enabling sponsors to make informed decisions about site selection, enrollment projections, and resource allocation. This comprehensive evaluation examines multiple dimensions of trial viability, including the availability of suitable patient populations, investigator expertise and interest, site infrastructure and experience, competitive trial landscape, and regulatory considerations specific to each country or region under consideration.

The feasibility process typically involves both quantitative and qualitative data collection. Sponsors distribute feasibility questionnaires to potential sites requesting information about patient databases, standard of care practices, staffing levels, equipment availability, and projected enrollment rates. Site visits may be conducted to verify questionnaire responses and assess factors difficult to capture in written surveys, such as team dynamics, facility conditions, and investigator engagement. Analysis of historical enrollment data from similar trials provides context for evaluating site projections.

Thorough feasibility assessment directly impacts trial success by identifying sites most likely to meet enrollment targets and maintain quality performance. Sites with optimistic projections but limited access to eligible patients contribute to enrollment delays that extend timelines and increase costs. Conversely, overlooking capable sites may unnecessarily limit the enrollment base. Modern feasibility increasingly incorporates data analytics, leveraging electronic health record data and claims databases to objectively quantify patient populations, though these approaches must be balanced against practical site-level factors that influence actual enrollment.