Feasibility in a non-commercial clinical trial. How to assess project feasibility?
Feasibility assessment, or evaluating whether a non-commercial clinical trial can realistically be carried out, is one of the most important stages of project preparation, yet it is often overlooked. It helps determine whether the study can be completed within the planned timeline, budget, and available organizational resources. This is particularly important for non-commercial trials, where sponsors are often universities, hospitals, research institutes, or research teams with limited funding that need to plan the scope of activities very carefully.
The first step is to analyze the study assumptions or draft protocol. It is important to assess whether the inclusion and exclusion criteria are realistic, whether the patient population is accessible, how many visits are planned, which procedures need to be performed, and whether requirements related to diagnostics, hospitalization, safety monitoring, documentation, or investigational product storage can be met at the planned sites.
A very important part of feasibility is assessing recruitment potential. Sites should estimate how many patients who meet the study criteria they can identify and enroll within a given timeframe. In practice, it is important to consider not only the number of patients treated at a particular facility, but also potential limitations such as competing trials, low patient response, contraindications, refusals to participate, or a high number of patients who do not meet the eligibility criteria.
Another key area is the organizational readiness of the sites and sponsor. It is necessary to verify the availability of appropriate staff, clinical research experience, administrative support, data collection systems, safety reporting procedures, documentation capabilities, and the time resources required to conduct the study in accordance with the protocol.
Feasibility in a non-commercial trial should also include an assessment of the budget and timeline. Even a scientifically valuable project can prove difficult to execute if the recruitment period is too short, procedure costs are underestimated, or activities such as monitoring, medical monitoring, pharmacovigilance, data management, statistics, archiving, or team costs have been overlooked. Therefore, the feasibility assessment should combine medical, operational, financial, and regulatory perspectives.
In practice, feasibility can be conducted through questionnaires sent to potential sites, discussions with investigators, analysis of epidemiological data, review of similar projects, assessment of patient availability, and verification of regulatory requirements. For non-commercial trials, it is also particularly important to determine which tasks the sponsor can handle independently and which require support from a CRO or other external partners and service providers.
A well-conducted feasibility assessment helps identify suitable sites, establish a realistic timeline, verify the budget, and identify risks before the project begins. This allows the sponsor of a non-commercial clinical trial to better prepare the documentation, plan financing, and increase the chances of efficient and successful trial execution.
