Clinical OperationsGlossary Term
ICH E6(R3) Section 5.5
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
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.
Pre-study planning
"The sponsor conducted feasibility assessments at 120 sites across 15 countries, ultimately selecting 45 sites based on patient population availability, investigator experience in the therapeutic area, and historical enrollment performance."
Feasibility questionnaire
"The feasibility questionnaire asked sites to estimate the number of patients seen monthly meeting key eligibility criteria, identify competing trials, and confirm availability of required diagnostic equipment."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
ICH E6(R3) Section 5.5
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
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.
Pre-study planning
"The sponsor conducted feasibility assessments at 120 sites across 15 countries, ultimately selecting 45 sites based on patient population availability, investigator experience in the therapeutic area, and historical enrollment performance."
Feasibility questionnaire
"The feasibility questionnaire asked sites to estimate the number of patients seen monthly meeting key eligibility criteria, identify competing trials, and confirm availability of required diagnostic equipment."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.