What is a clinical-trial feasibility assessment?
Clinical-trial feasibility assessment is a systematic analysis of the conditions under which a planned study can be carried out. It evaluates site potential, population availability, legislative compliance, and epidemiological and operational factors. The goal is to confirm that the study protocol can be implemented effectively—on schedule, within budget, and in line with regulations.
Why feasibility assessment matters for trial success
Failure to perform a thorough feasibility analysis often results in delays, study termination, or errors that undermine data quality. Common problems include recruitment difficulties, logistical mistakes, incomplete data, or the need to replace sites. For IVD performance studies this risk is higher because of diagnostic requirements and access to suitable biological samples.
Feasibility assessment at protocol level
The process starts with a realistic review of protocol assumptions, verifying:
- participant inclusion and exclusion criteria,
- number and frequency of visits,
- laboratory and diagnostic requirements,
- procedures for sample collection and transport,
- availability of the target analyte (for IVD studies).
Local clinical practice and site capabilities must be considered to avoid later protocol amendments.
Assessing investigational-site potential
Each prospective site must be evaluated for:
- technical infrastructure and equipment availability,
- experience of the study team and qualifications of the principal investigator,
- quality-assurance systems and GCP compliance,
- recruitment history and previous research projects,
- access to certified laboratories or molecular diagnostics.
This process is an integral part of site selection and has a major impact on subsequent study execution.
Epidemiological feasibility verification
Epidemiological assessment analyses the occurrence of the target disease in the local population, taking into account:
- regional disease prevalence,
- seasonality of symptoms and recruitment fluctuations,
- effects of public-health campaigns or vaccination programmes,
- the ability to obtain protocol-compliant samples (especially in IVD studies).
This analysis allows realistic estimation of recruitment speed and patient availability.
Legislative and regulatory feasibility assessment
Legislative differences between countries directly affect study timelines and costs. The regulatory analysis examines:
- ethics-committee requirements,
- submission timelines and procedures,
- required registration documentation,
- sponsor obligations under local law,
- conditions for registering the study in the EUDAMED database.
A well-executed legal review helps avoid administrative delays and procedural non-compliance.
Selecting study locations and population availability
Access to the appropriate population is a key criterion for location selection. The analysis includes:
- population density and demographic profile,
- availability of patients who meet the criteria,
- socio-economic factors affecting participation,
- patient travel logistics to and from the site.
Neglecting these elements can lead to participant shortages, schedule extensions, and the need to expand the study to additional locations.
A multifaceted approach to feasibility analysis
Comprehensive feasibility analysis should be based on triangulating sources:
- epidemiological data and health statistics,
- site feasibility questionnaires,
- interviews with clinical and regulatory experts,
- reviews of previous study outcomes,
- mapping operational risks and GCP compliance.
Potential risks related to clinical-trial monitoring and participant data protection should also be considered.
The role of local partners in feasibility assessment
Engaging local partners (e.g., CROs, SMOs, expert organisations) greatly increases the accuracy and speed of the assessment. Such partners have:
- knowledge of registration and regulatory procedures,
- access to sites and recruitment databases,
- operational experience in the given country or region.
Their involvement minimises errors stemming from unfamiliarity with local conditions.
How Pure Clinical Supports Clinical Study Feasibility Assessment
Pure Clinical supports sponsors in assessing the feasibility of clinical investigations of medical devices in the EU and other markets. A feasibility assessment helps determine whether a planned study can be conducted within a specific regulatory, clinical, and operational environment and identifies conditions that may affect study execution.
Depending on the project, support may include:
- Protocol and local conditions assessment – review of protocol assumptions against local regulatory, clinical, and organisational requirements.
- Clinical and regulatory feasibility assessment – assessment of target population availability, study conditions, and applicable regulatory requirements.
- Site and infrastructure assessment – evaluation of potential sites, including their experience, resources, and available infrastructure.
- Operational and recruitment risk assessment – identification of potential constraints related to participant recruitment, study conduct, and resource availability.
- Location mapping – identification and assessment of potential study locations based on the characteristics and availability of the target population.
- Operational review – assessment of selected operational processes and conditions relevant to the planned study.
A feasibility assessment provides sponsors with information to evaluate study conditions, identify suitable locations and sites, and identify potential constraints before the clinical investigation begins.
FAQ
What digital tools can support real-time clinical trial feasibility assessment?
What are the most common false assumptions when planning feasibility assessments?
A common mistake is assuming that a site's past performance guarantees similar success in a new trial. Ignoring local cultural differences, language barriers, or staff engagement levels leads to overestimation. Many projects also rely on site-reported estimates without objective validation using historical recruitment metrics.
How can the effectiveness of a feasibility assessment be measured after trial completion?