03 · What You Need to Know
How AI Can Support Pilot and Feasibility Study Development
What Is the Difference Between a Pilot Study and a Feasibility Study?
The terms are frequently used interchangeably, but methodological guidance distinguishes their purposes.
Eldridge and colleagues (2016) explain that feasibility studies investigate whether a future study can be undertaken and how it should be conducted. Pilot studies are a subset of feasibility studies in which a future study, or part of it, is conducted on a smaller scale.
Feasibility study
Investigates whether a proposed study or intervention can be implemented and what modifications may be required.
Pilot study
Tests part or all of the intended future study on a smaller scale to evaluate its procedures and implementation.
For example, interviewing instructors about whether an AI tutoring intervention could fit existing teaching arrangements may form part of feasibility research.
Conducting a small-scale version of the proposed randomized trial, including recruitment, allocation, intervention delivery, and outcome assessment, would more specifically resemble a pilot trial.
Researchers should identify the actual purpose rather than rely on the term pilot simply because the sample is small.
Why Should Feasibility Questions Come Before Effectiveness Questions?
A full-scale intervention evaluation may fail because participants cannot be recruited, the intervention is inconsistently delivered, or important outcome data cannot be collected.
These problems may exist independently of whether the intervention has a beneficial effect.
For example, an AI tutoring system might appear promising, but students may not use it consistently, technical access may be unreliable, or instructors may find implementation incompatible with course schedules.
A feasibility study can investigate these uncertainties before substantial resources are committed to a definitive evaluation.
Its primary questions should therefore concern whether the future research can be conducted and what changes are necessary.
What Feasibility Outcomes Can AI Help Identify?
AI may help organize feasibility objectives across recruitment, implementation, measurement, and participant experience.
| Feasibility domain |
Illustrative question |
Possible indicator |
| Recruitment |
Can sufficient eligible participants be enrolled within the available period? |
Number recruited per week or proportion consenting. |
| Retention |
Can participants remain in the study until the required assessments? |
Proportion completing follow-up. |
| Intervention delivery |
Can the intervention be implemented as specified? |
Completion of planned sessions or delivery components. |
| Adherence |
Do participants engage with the intervention as intended? |
Proportion meeting prespecified usage or participation criteria. |
| Measurement feasibility |
Can the required outcome data be obtained? |
Completeness and usability of assessment records. |
| Acceptability |
Do participants and implementers consider the procedures acceptable? |
Survey responses, interviews, or documented feedback. |
| Technical feasibility |
Can the required technology operate reliably in the research setting? |
Access failures, interruptions, or unresolved technical incidents. |
Not every study requires all these outcomes. The appropriate selection depends on the uncertainties that could prevent the main study from proceeding.
What Are Progression Criteria?
Progression criteria are prespecified conditions used to inform whether a study should proceed to a larger investigation, proceed with modifications, or undergo substantial reconsideration.
Avery and colleagues (2017) discuss the importance of progression criteria in external pilot randomized trials.
For example, a researcher might specify minimum recruitment, retention, and intervention-delivery targets before beginning the pilot.
These criteria should reflect the requirements of the intended main study, relevant prior evidence, and stakeholder or methodological judgment.
AI may suggest candidate thresholds, but it cannot establish their appropriateness without sufficient contextual information.
Should Progression Criteria Use a Traffic-Light System?
Some pilot studies use a traffic-light approach to organize progression decisions.
| Category |
Illustrative interpretation |
Possible decision |
| Green |
Prespecified feasibility conditions are sufficiently met. |
Consider proceeding under the planned or appropriately refined protocol. |
| Amber |
Feasibility concerns exist but may be addressable. |
Consider modifications and further assessment. |
| Red |
Important feasibility conditions are not met. |
Reconsider the design, intervention, or decision to proceed. |
The labels themselves do not determine scientific decisions. Thresholds and their interpretation should be established before the results are examined, while allowing justified consideration of qualitative evidence and contextual circumstances.
A red result does not necessarily mean that the intervention is ineffective. It may indicate that the research procedures or implementation arrangements are not sufficiently feasible.
Can AI Recommend a Pilot Study Sample Size?
AI can explain sample-size considerations, but it should not provide a universal number without examining the study's objectives.
For example, a pilot designed to estimate a recruitment proportion with a specified degree of precision may require a different sample size from one intended to examine intervention delivery across several classrooms.
Whitehead and colleagues (2016) discuss sample-size considerations for pilot randomized trials in relation to planning future studies.
However, their recommendations apply to particular objectives and assumptions. They should not be treated as a universal rule for every pilot or feasibility investigation.
Researchers should determine which feasibility parameter needs estimation, the required precision, the unit of recruitment or randomization, and the resources available.
Should a Pilot Study Test Whether the Intervention Is Effective?
A pilot study may collect clinical, educational, or behavioral outcomes to assess whether measurement procedures work and to obtain preliminary information relevant to planning.
However, small pilot studies are generally not designed to provide definitive tests of intervention effectiveness.
Using statistical significance as the main criterion for deciding whether to proceed can be misleading because pilot samples are often too small to estimate intervention effects precisely.
Eldridge and colleagues (2016) emphasize the feasibility purpose of pilot studies conducted in preparation for randomized trials.
Researchers should distinguish feasibility outcomes from exploratory effectiveness outcomes and avoid interpreting an inconclusive significance test as evidence that the intervention does not work.
Watch Out
Do not judge a pilot study primarily by whether its intervention effect reaches p < 0.05. A pilot may successfully establish recruitment and measurement feasibility even when the effectiveness estimate is highly uncertain.
Can AI Help Design a Pilot Randomized Trial?
Yes. AI may assist in planning a smaller-scale evaluation of recruitment, randomization, allocation concealment, intervention delivery, follow-up, and data collection.
For example, a researcher might pilot a proposed randomized study of AI-generated feedback to determine whether students can be assigned to conditions and whether blinded writing assessment can be implemented.
However, a pilot trial should preserve the essential procedures that need testing. Omitting randomization from a pilot intended to evaluate the feasibility of randomization would leave that particular uncertainty unresolved.
Researchers should examine randomization procedures and feasible blinding arrangements when these form part of the intended definitive trial.
Can Feasibility Research Use Qualitative Methods?
Yes. Interviews, observations, and other qualitative approaches may provide important evidence about why particular procedures are acceptable, difficult, or impractical.
For example, a recruitment target may not be achieved because students misunderstand the study, instructors are reluctant to release class time, or institutional procedures delay enrollment.
Numerical recruitment rates identify the problem but may not explain its causes.
Qualitative inquiry can help researchers understand implementation barriers and develop justified modifications.
Where quantitative and qualitative components are intentionally integrated, the feasibility study may incorporate a mixed-methods approach. The rationale for integration should be explicit.
How Can AI Help Identify Feasibility Problems Specific to Educational Technology?
Educational technology interventions may involve requirements that are not adequately captured by generic research templates.
These may include platform access, internet reliability, device compatibility, institutional data protection requirements, licensing restrictions, technical support, and the ability to maintain consistent intervention exposure.
For example, a study using a commercial generative AI platform may be affected by changes to model behavior, access conditions, or available features during implementation.
AI may help identify these risks, but the researcher must verify the actual platform conditions and institutional requirements.
This is one reason to examine whether AI recommendations overlook field-specific constraints.
What Should a Feasibility Study Produce?
A useful feasibility study should inform a practical decision about the future investigation.
Its outputs may include recruitment estimates, retention information, implementation findings, measurement problems, acceptability evidence, and recommended protocol modifications.
It should also document which uncertainties remain unresolved.
A favorable feasibility result does not establish intervention effectiveness. Conversely, identifying implementation problems may be a valuable outcome because it prevents an inadequately prepared definitive study from proceeding.
How Can You Use AI to Plan a Feasibility Study Systematically?
1. Describe the intended main study. Identify the research question, design, intervention, population, and proposed procedures.
2. Identify critical uncertainties. Determine which implementation or methodological questions could prevent the main study from succeeding.
3. Formulate feasibility objectives. Translate the uncertainties into specific questions about recruitment, delivery, measurement, retention, or acceptability.
4. Select appropriate indicators. Define what information will be collected to evaluate each feasibility objective.
5. Establish progression criteria. Specify contextually justified thresholds or decision rules before collecting data.
6. Determine sample and procedures. Select a design sufficient to investigate the feasibility objectives rather than relying on arbitrary pilot sample sizes.
7. Plan interpretation and revision. Explain how findings will inform decisions about proceeding, modifying, or reconsidering the main study.
The proposed feasibility study should then undergo appropriate methodological and ethical review before implementation.