Feasibility of a Research Study: How to Assess Before You Start

A feasibility assessment is the process of determining whether a proposed research study can be conducted as planned before committing substantial time, funding, and personnel. This article provides a practical framework for evaluating resource availability, participant recruitment capability, data collection procedures, and timeline realism. The framework applies to students planning thesis projects, researchers designing clinical or laboratory studies, and life-science professionals who need to decide whether to proceed with a full investigation or modify their approach first.

Feasibility studies answer the overarching question of whether a planned investigation can work in practice. They are designed to assess recruitment capability and resulting sample characteristics, data collection procedures and outcome measures, acceptability of the intervention and study procedures, resources and ability to manage and implement the study, and preliminary evaluation of participant responses to the intervention. Each of these objectives has follow-up questions that help researchers understand barriers to the ultimate success of the research. The OTJR article on the distinctive features of a feasibility study identifies these five overarching objectives and emphasizes that feasibility work focuses on process instead of treatment effects.

At a Glance

The table below summarizes the core domains you must evaluate before starting a research study. Use it as a checklist during your initial planning conversations.

Understanding What Feasibility Means in Research

Feasibility is an overarching term for preliminary studies that test whether a larger investigation can be done. A pilot study is a specific type of feasibility work that resembles the intended trial in aspects such as having a control group and randomization. The distinction matters because researchers often misuse these labels. The Contemporary Clinical Trials article on pilot and feasibility studies explains that feasibility should be used as an umbrella term for preliminary studies, while pilot refers to a smaller version of the planned trial. Studies labeled pilot should have different aims and objectives from main trials and should include an intention for future work. Researchers should not use the title pilot for a trial that evaluates a treatment effect.

Feasibility research focuses on the intervention process and addresses questions about whether and how an intervention can be evaluated and implemented. Feasibility studies are implemented prior to conducting an outcome-focused pilot study or full-scale evaluation to test the effectiveness of an intervention. The Journal of School Psychology article on incorporating feasibility protocols proposes a framework with ten possible dimensions to evaluate in a feasibility trial. These dimensions include recruitment capability, data collection procedures, design procedures, social validity, practicality, integration into existing systems, adaptability, implementation, effectiveness, and generalizability.

For students and early-career researchers, the practical implication is straightforward. A feasibility assessment is not a smaller version of your main study. It is a separate investigation with its own objectives focused on whether the main study can be conducted at all. If you skip this step, you risk discovering mid-study that your recruitment strategy cannot reach target numbers, your measurement tools do not capture the outcomes you need, or your timeline cannot accommodate the required procedures.

Core Principles of Feasibility Assessment

Define Feasibility Objectives Before Designing Procedures

The first principle is that feasibility objectives must be explicit and stated before you design your study procedures. A review of pilot and feasibility studies in rehabilitation research found that only one third of studies provided a primary objective related to feasibility, while most studies stated an intent for hypothesis testing. The American Journal of Physical Medicine and Rehabilitation educational primer recommends that researchers correctly label studies as pilot or feasibility design based on accepted definitions, explicitly state feasibility objectives, outcomes, and criteria for determining success, justify the sample size, and appropriately interpret the implications of feasibility findings for the main future study.

Write your feasibility objectives as measurable questions. Examples include the following. Can we recruit 30 eligible participants within 12 weeks? Can we complete each study visit within 60 minutes? Can we retain at least 80 percent of enrolled participants through the final follow-up? Can we collect complete outcome data on at least 90 percent of enrolled participants? Each objective needs a numeric criterion that defines success.

Distinguish Feasibility From Hypothesis Testing

Feasibility studies should not test treatment comparisons or estimate effect sizes for the main intervention. The Contemporary Clinical Trials article notes that all reflective papers agree that feasibility and pilot studies should not test treatment comparisons nor estimate feasible effect sizes, although this is not universally observed in practice. If your research question requires comparing outcomes between groups, you need a fully powered trial, not a feasibility study.

This principle protects you from drawing incorrect conclusions. A small feasibility sample cannot provide reliable estimates of treatment effects. Its purpose is to tell you whether the machinery of the study works. Save your statistical power calculations for the main trial.

Plan for Progression Criteria

Progression criteria are the predetermined standards that tell you whether to move from feasibility work to a full study. The rehabilitation research review found that reporting of progression plans to a main study occurred in only 21 percent of studies and progression criteria in only 4 percent. The educational primer identifies this as a major gap in practice.

Set your progression criteria before you start collecting feasibility data. For example, you might decide that the main study is feasible if you achieve at least 70 percent of your recruitment target, retain at least 75 percent of participants, and complete data collection procedures within the planned time for at least 80 percent of visits. Document these criteria in your feasibility protocol so that the decision to proceed is transparent and defensible.

Resource Availability Assessment

Personnel and Expertise

The first resource question is whether you have the right people with the right skills for every study procedure. List each task in your study protocol and identify who will perform it. Common tasks include participant screening, informed consent, intervention delivery, data collection, equipment operation, data entry, and statistical analysis. For each task, ask whether the assigned person has done this work before and whether they have time in their schedule.

The Clinical Nursing Research article on conducting a device feasibility study emphasizes that feasibility studies are often the first attempt to test whether a new process or part of a process is practical for use in a clinical setting or whether a device will provide the desired information. Device studies have unique considerations that must be addressed, including whether staff can operate the device correctly and whether the device performs reliably in the intended setting.

If you identify a skill gap, you have three options. You can train existing personnel, hire or recruit additional personnel, or modify the study procedures to match available skills. Each option has cost and timeline implications that belong in your feasibility assessment.

Equipment and Facilities

Equipment feasibility goes beyond whether the instrument exists in your building. You must verify that the equipment is available during the hours you need it, that it is calibrated and maintained, and that you have the consumables required for the full study duration. For specialized equipment, confirm that you have technical support if the instrument fails mid-study.

The Nature Protocols article on magnetoencephalography research describes planning, piloting, implementation, and quality assurance for a complex neuroimaging modality. The authors note that existing resources on MEG research best practices have restricted focus on data acquisition, processing, and analysis steps. Their protocol extends beyond these steps to address planning, piloting, implementing the procedure, and maintaining quality assurance. They describe methodological considerations that enhance procedure efficiency, align implementation with research goals, improve data quality, reduce participant burden, and optimize financial resources. The MEG experimental procedure in their example required about two hours per participant, and pilot and main study data acquisition spanned about five years.

The lesson for any research project is that equipment feasibility includes the full lifecycle of the instrument, from scheduling to maintenance to data output. A machine that works perfectly in a demonstration may fail under the demands of daily study use.

Budget and Funding

Build a line-item budget that covers personnel time, equipment purchase or rental, consumables, participant compensation, data management, and publication costs. Compare this budget against your available funding. If a gap exists, identify which items can be reduced, which can be deferred, and which are essential.

The RAVENTA trial design article illustrates how a multicenter feasibility trial manages resources across sites. The planned study involved high-precision image-guided single-session radiosurgery delivered to a cardiac target, with a planned sample size of 20 patients and a goal of demonstrating safety and feasibility in at least 70 percent of patients. Quality assurance was provided by initial contouring and planning benchmark studies, joint multicenter treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.

For a student project, the budget question is simpler but equally important. Can you afford the full study, or only part of it? If you can only afford part, which feasibility questions can you answer with the available resources?

Participant Recruitment Capability

Estimating the Eligible Population

Recruitment feasibility starts with a realistic estimate of how many eligible participants exist in your catchment area. Use clinic records, population databases, or published recruitment rates from similar studies. If you cannot identify a source for this estimate, that is a feasibility finding in itself.

The MICRA trial design article provides an example of recruitment assessment in a multicenter cohort study. During the first year of the trial, 58 patients with radiologic complete response were included. One patient was a screening failure and excluded from analysis. The study team documented that in seven patients biopsies could not be obtained, in six patients the marker could not be identified on ultrasound, and in one patient there were technical difficulties. This level of detail about recruitment and procedure failures is exactly what a feasibility assessment should capture.

Calculating Recruitment Rate

Your recruitment rate is the number of eligible participants you can enroll per week or per month. Calculate this rate from your eligible population estimate and your recruitment timeline. Then compare the rate against your target sample size to determine whether your timeline is realistic.

For example, if you need 100 participants and your recruitment rate is five per week, you need 20 weeks of recruitment. Add time for screening failures, no-shows, and dropouts. If your rate estimate comes from a different population or setting, adjust it conservatively.

Identifying Recruitment Barriers

Recruitment barriers are the reasons eligible participants do not enroll. Common barriers include travel distance, time commitment, discomfort or risk from procedures, mistrust of researchers, and competing demands on participants time. The BMJ Open study on media training for journalists provides an example of recruitment in a small pragmatic feasibility study. Eight journalists were recruited through the study's journalist advisor and existing contacts of the researchers. All participants completed preworkshop and postworkshop questionnaires, and six completed the six-week follow-up, giving a 75 percent retention rate.

The lesson is that recruitment often depends on existing relationships and referral networks. Identify these networks early and document which recruitment channels produce eligible participants.

Data Collection Procedures and Outcome Measures

Testing Measurement Instruments

Your outcome measures must be tested in the population you plan to study. A questionnaire that works in one population may be confusing or irrelevant in another. A biological assay that works in a research laboratory may fail in a clinical setting. The feasibility assessment should include a small test of each measurement instrument.

The Journal of Comparative Effectiveness Research article on pre-study feasibility addresses this issue for researchers using healthcare databases. The authors note that researchers must understand their data source and whether outcomes, exposures, and confounding factors are captured sufficiently to address the research question. They must also assess whether bias and confounding can be adequately minimized. The article proposes pre-study steps for feasibility assessment and identifies sensitivity analyses that might be most important to pre-specify.

For primary data collection, test your instruments on a small sample and document completion rates, missing data patterns, and participant feedback. If participants skip questions, misunderstand instructions, or refuse procedures, you need to know before the main study starts.

Evaluating Data Management Systems

Data management feasibility covers how you will store, clean, and analyze your data. You need a system for secure data storage, a plan for data entry and verification, and a statistical analysis plan that matches your data types. The National Institute of Standards and Technology Research Data Framework provides guidance on managing research data across the data lifecycle. The framework addresses how researchers can organize, document, and preserve data so that it remains usable and interpretable.

Test your data management system during the feasibility phase. Enter sample data, run your planned analyses, and verify that the output answers your research questions. If your analysis plan requires software or statistical expertise you do not have, identify that gap now.

Assessing Procedure Acceptability

Acceptability refers to whether participants will tolerate the study procedures. The Trials article on embedding qualitative research in trials describes how qualitative research can enhance the design, conduct, and interpretation of trials. The authors draw on their experience with the SAFER trial feasibility study, a cluster randomized controlled trial of screening people aged 70 and above for atrial fibrillation in primary care. The qualitative team contributed to important changes in the design and conduct of the feasibility study, including asking practices to give screening results to all participants and beyond to screen positive participants, and greater recognition of the contribution of practice reception staff to trial delivery.

Qualitative methods can reveal acceptability problems that quantitative data miss. If participants find a procedure burdensome, embarrassing, or confusing, they may drop out or provide poor quality data. Include qualitative feedback mechanisms in your feasibility assessment, such as exit interviews, debriefing sessions, or open-ended survey questions.

Timeline Realism

Building a Task-by-Task Schedule

A realistic timeline breaks the study into discrete tasks and assigns a duration to each. Common tasks include protocol development, ethics or institutional review board approval, recruitment, data collection, data analysis, and manuscript preparation. For each task, estimate the duration based on your specific circumstances, not on an idealized version of the study.

The Nature Protocols MEG article provides a concrete example of timeline planning. The authors note that the entire protocol requires multiple months to years depending on study size. Their MEG experimental procedure required about two hours per participant, and pilot and main study data acquisition spanned about five years. This example illustrates that complex procedures require substantial time beyond the data collection itself.

Accounting for Approval Processes

Institutional review board or ethics committee approval is a common source of timeline delay. The processing time varies by institution and by the level of risk in your study. Check with your institution for current processing times and build this into your schedule. If your study involves multiple sites, each site may require separate approval.

Building in Buffer Time

Every study encounters unexpected delays. Equipment breaks, participants cancel, staff become ill, and data files become corrupted. Build buffer time into each phase of your schedule. A common approach is to add 20 to 30 percent to each task duration. If your timeline has no buffer, any single delay will push your completion date.

Practical Implementation Steps

Step 1: Write Your Feasibility Objectives

List the specific questions your feasibility assessment must answer. Use the five objectives from the OTJR article as a starting point. For each objective, write a measurable question and a criterion for success.

Step 2: Inventory Your Resources

Create a table listing every resource your study requires, including personnel, equipment, facilities, funding, and data systems. For each resource, record whether it is available, partially available, or unavailable. Identify the gaps and estimate the cost and time to fill them.

Step 3: Estimate Recruitment Capability

Identify your eligible population and calculate a projected recruitment rate. Document the sources for your estimate. Identify your recruitment channels and estimate the yield from each channel.

Step 4: Test Your Procedures

Run a small test of your measurement instruments, data collection procedures, and data management system. Document completion rates, missing data, and participant feedback.

Step 5: Build Your Timeline

Create a task-by-task schedule with durations and buffer time. Identify the critical path and the tasks that cannot be delayed without delaying the entire study.

Step 6: Set Progression Criteria

Write the numeric criteria that will tell you whether to proceed to the main study. Document these criteria in your feasibility protocol.

Step 7: Conduct the Feasibility Study

Execute your feasibility plan and collect data on each objective. Document everything, including failures and unexpected findings.

Step 8: Make the Go or No-Go Decision

Compare your feasibility data against your progression criteria. If you meet the criteria, proceed to the main study. If you partially meet the criteria, modify your approach and consider another feasibility round. If you do not meet the criteria, do not proceed.

Records and Measurements

What to Record During Feasibility Work

Keep a feasibility log that documents the following items. Track the number of participants screened, eligible, enrolled, and completed. Record the reasons for exclusion, refusal, and dropout. Document the time required for each study procedure. Record equipment failures and downtime. Track data completeness and missing data patterns. Document all costs and resource use. Record protocol deviations and the reasons for them.

The PLoS ONE study on voice activated remote monitoring for heart failure patients provides an example of detailed feasibility measurement. The study assessed the feasibility of voice activated technology for monitoring heart failure patients. The technical infrastructure was successfully set up and two thirds of the invited study participants interacted with the technology. Patients reported favorable perception and high comfort level with the technology. The responses from participants varied widely, and higher perceived symptom burden was not associated with hospitalization on qualitative assessment of the data visualization plot.

How to Use Feasibility Data

Feasibility data serve two purposes. First, they inform your go or no-go decision. Second, they inform the design of the main study. If your feasibility data show that recruitment is slower than expected, you may need to add recruitment sites or extend the recruitment period. If data collection procedures take longer than planned, you may need to simplify the protocol or add staff. If participants find a procedure unacceptable, you may need to modify or replace it.

Common Failure Patterns

Failure to Define Feasibility Objectives

Many studies labeled as feasibility or pilot do not state a primary feasibility objective. The rehabilitation research review found that only one third of studies provided a primary objective related to feasibility, while most stated an intent for hypothesis testing. This failure pattern leads to studies that cannot answer the questions they were designed to address.

Confusing Feasibility With Hypothesis Testing

Researchers who use feasibility studies to test treatment effects draw conclusions that their sample size cannot support. The Contemporary Clinical Trials article documents that this practice persists despite agreement in the literature that feasibility studies should not test treatment comparisons.

Ignoring Progression Criteria

Studies that collect feasibility data without predefined progression criteria leave the go or no-go decision to subjective judgment. The educational primer found that only 4 percent of studies reported progression criteria. Without criteria, researchers may proceed to a main study that is not feasible or abandon a study that could have succeeded with modifications.

Underestimating Recruitment Time

Recruitment consistently takes longer than researchers expect. The MICRA trial documented detailed recruitment outcomes during its first year, including screening failures and technical difficulties with biopsy procedures. These details are the kind of information that feasibility assessments must capture.

Neglecting Qualitative Feedback

Quantitative feasibility data can tell you that participants dropped out, but not why they dropped out. The Trials article on qualitative research demonstrates how qualitative methods can identify problems and inform changes that improve study design and conduct. Skipping qualitative feedback leaves you without the information needed to fix recruitment and retention problems.

Limitations of Feasibility Assessment

Small Sample Sizes

Feasibility studies use small samples by design. These samples cannot provide reliable estimates of treatment effects, adverse event rates, or other clinical outcomes. The RAVENTA trial design planned a sample size of 20 patients with the goal of demonstrating safety and feasibility in at least 70 percent of patients. This sample size is appropriate for feasibility but cannot establish the full safety profile of the intervention.

Context Specificity

Feasibility findings from one setting may not transfer to another. A recruitment strategy that works in an urban academic medical center may fail in a rural community clinic. A measurement instrument that works in one population may not work in another. The Pilot and Feasibility Studies article on physical activity research in multiple sclerosis addresses the importance of considering feasibility in specific populations and contexts.

Time and Cost

Feasibility assessment itself requires time and resources. For a student with a fixed graduation date or a researcher with a funding deadline, the time spent on feasibility work may delay the main study. However, the cost of a failed main study is typically much higher than the cost of a feasibility assessment.

Welfare and Safety Context

Participant Safety Monitoring

Feasibility studies must include the same safety monitoring as any research involving human participants. The RAVENTA trial design illustrates comprehensive safety monitoring in a feasibility trial, including sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board. Even a small feasibility study should have a plan for monitoring adverse events and a process for reporting them to the appropriate oversight body.

Ethical Review

Feasibility studies require ethical review before they begin. The EQUATOR Network provides reporting guidelines for health research, including guidelines relevant to feasibility and pilot studies. Consult the appropriate reporting guideline for your study type and use it to structure your feasibility protocol and report.

Data Protection

Feasibility studies collect participant data that must be protected according to applicable regulations. The National Center for Biotechnology Information and PubMed provide access to the biomedical literature, including articles on research data management and participant privacy. Ensure that your data management plan addresses data security, participant confidentiality, and data retention.

Professional Escalation Criteria

When to Consult a Biostatistician

Consult a biostatistician before you finalize your feasibility objectives and progression criteria. A biostatistician can help you determine whether your planned sample size can answer your feasibility questions and whether your progression criteria are appropriate. If you do not have access to a biostatistician, consult the NC3Rs Experimental Design Assistant for guidance on experimental design and sample size planning.

When to Consult an Ethics Committee

Consult your institutional review board or ethics committee early in your planning process. They can tell you whether your study requires review, what documents you need to submit, and what the processing time will be. If your study involves vulnerable populations, multiple sites, or high-risk procedures, seek their guidance before you invest substantial time in protocol development.

When to Stop the Feasibility Study

Stop the feasibility study if you encounter problems that cannot be resolved within your timeline or budget. Examples include recruitment rates far below projections, equipment that cannot be made to work reliably, or participant refusal rates that make the study procedures unacceptable. Stopping a feasibility study is a valid outcome. It prevents the larger waste of a failed main study.

Frequently Asked Questions

What is the difference between a feasibility study and a pilot study?

Feasibility is the overarching term for preliminary studies that test whether a larger investigation can be done. A pilot study is a specific type of feasibility work that resembles the intended trial in aspects such as having a control group and randomization. The Contemporary Clinical Trials article explains that studies labeled pilot should have different aims and objectives from main trials and should include an intention for future work.

How many participants do I need for a feasibility study?

The sample size for a feasibility study depends on your feasibility objectives. You need enough participants to answer questions about recruitment capability, data collection procedures, and acceptability. The RAVENTA trial planned 20 patients to demonstrate safety and feasibility in at least 70 percent of patients. Your sample size should be justified in your feasibility protocol based on your specific objectives.

Can I test treatment effects in a feasibility study?

No. Feasibility studies should not test treatment comparisons or estimate effect sizes. The Contemporary Clinical Trials article notes that all reflective papers agree on this point. If your research question requires comparing outcomes between groups, you need a fully powered trial.

What are progression criteria and why do I need them?

Progression criteria are the predetermined standards that tell you whether to move from feasibility work to a full study. The educational primer on pilot and feasibility studies found that only 4 percent of studies reported progression criteria. Without them, the decision to proceed is subjective and difficult to defend.

How long does a feasibility study take?

The duration depends on your study procedures, recruitment rate, and setting. The Nature Protocols MEG article notes that the entire protocol requires multiple months to years depending on study size. Build a task-by-task schedule with buffer time for each phase.

What should I do if my feasibility study shows problems?

Use the feasibility data to modify your approach. If recruitment is slow, add recruitment channels or extend the timeline. If procedures are burdensome, simplify them. If measurement instruments produce poor data, replace or revise them. If the problems cannot be resolved, do not proceed to the main study.

Do I need ethical approval for a feasibility study?

Yes. Feasibility studies involving human participants require ethical review before they begin. Consult your institutional review board or ethics committee early in your planning process. The EQUATOR Network provides reporting guidelines that can help you structure your feasibility protocol.

How do I report a feasibility study?

Report your feasibility study according to the appropriate reporting guideline for your study type. State your feasibility objectives explicitly, describe your methods, report your results against your progression criteria, and discuss the implications for the main study. The educational primer recommends that researchers explicitly state feasibility objectives, outcomes, and criteria for determining success, justify the sample size, and appropriately interpret the implications of feasibility findings for the main future study.

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References and Further Reading

• Research Data Framework. National Institute of Standards and Technology.
• EQUATOR Network. EQUATOR Network.
• Experimental Design Assistant. NC3Rs.
• NCBI Literature Resources. National Center for Biotechnology Information.
• PubMed. National Library of Medicine.
• The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions.. OTJR : occupation, participation and health, 2015.
• Conducting a Device Feasibility Study.. Clinical nursing research, 2019.
• How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme.. Trials, 2022.
• Pilot and feasibility studies: is there a difference from each other and from a randomised controlled trial?. Contemporary clinical trials, 2014.
• Incorporating feasibility protocols in intervention research.. Journal of school psychology, 2021.
• Interventions to improve media coverage of medical research: a codesigned feasibility and acceptability study with Australian journalists.. BMJ open, 2022.
• Pilot and Feasibility Studies in Rehabilitation Research: A Review and Educational Primer for the Physiatrist Researcher.. American journal of physical medicine & rehabilitation, 2022.
• Pre-study feasibility and identifying sensitivity analyses for protocol pre-specification in comparative effectiveness research.. Journal of comparative effectiveness research, 2014.
• Magnetoencephalography in human neuroscience research: planning, piloting, implementation and quality assurance.. 2026.
• 201 Evaluating a blended intensive program on ‘understanding the determinants of migrants’ health through research planning’ using Kirkpatrick’s model. 2025.
• 'It's not making a decision, it's prompting the discussions': a qualitative study exploring stakeholders' views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE).. 2024.
• Shaping urban environments to improve respiratory health: recommendations for research, planning, and policy.. 2024.
• ‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE). 2024.
• Planning ahead for research participation: survey of public and professional stakeholders' views about the acceptability and feasibility of advance research planning.. 2023.
• Voice activated remote monitoring technology for heart failure patients: Study design, feasibility and observations from a pilot randomized control trial. PLoS ONE, 2022.
• Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). Clinical Research in Cardiology, 2020.
• Feasibility study, design and implementation of smart polygeneration microgrid at AMU. 2017.
• Identifying pathologic complete response of the breast after neoadjuvant systemic therapy with ultrasound guided biopsy to eventually omit surgery: Study design and feasibility of the MICRA trial (Minimally Invasive Complete Response Assessment).. Breast, 2018.
• Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review. Journal of Pain and Symptom Management, 2017.
• A website for pilot and feasibility studies: Giving your research the best chance of success. Pilot and Feasibility Studies, 2019.
• Important considerations for feasibility studies in physical activity research involving persons with multiple sclerosis: A scoping systematic review and case study. Pilot and Feasibility Studies, 2018.

This article is educational and does not replace institutional policy, professional advice, or applicable safety and regulatory requirements.