Clinical Trial Feasibility Assessment: A Practical Guide

Clinical trial feasibility assessment is the systematic evaluation of whether a proposed study can be successfully conducted at one or more sites before resources are committed to full trial initiation. This process examines site capacity, patient recruitment potential, operational readiness, and protocol practicality. For researchers, students, and life-science professionals, a structured feasibility assessment reduces the risk of trial delays, under-enrollment, and wasted investment. This guide provides a practical framework for conducting feasibility assessments, including site evaluation criteria, recruitment forecasting methods, and operational checkpoints.

What Feasibility Assessment Determines

Feasibility assessment answers a direct question: can this trial be completed as designed, at the proposed sites, within the planned timeline, and with the available resources? The assessment covers four interconnected domains. First, site capability includes investigator experience, staff availability, equipment access, and institutional support. Second, patient recruitment potential examines whether enough eligible participants exist within the catchment area and whether they can be identified and enrolled. Third, operational readiness addresses protocol complexity, data collection requirements, and regulatory preparedness. Fourth, financial viability considers whether the budget covers actual costs including staff time, participant reimbursements, and infrastructure needs.

Recruitment failure is the most common cause of trial delay. Approximately 80 percent of trials fail to meet their initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies [21]. A feasibility assessment that accurately forecasts recruitment is therefore not an administrative formality but a core risk management activity.

At a Glance: Feasibility Assessment Domains

Core Principles of Feasibility Assessment

Start with Protocol Realism

The protocol is the foundation of every feasibility question. A protocol that is scientifically sound but operationally impossible will fail at the site level. Assess the protocol for procedural burden, visit frequency, follow-up duration, and data collection complexity. Consider whether the eligibility criteria are too restrictive for the available patient pool. In a single specialist centre study of cerebral amyloid angiopathy, 146 of 186 patients in a prospective database were ineligible for a small biomarker pilot study, with the most common reasons being co-existent cognitive impairment or dementia, failure to meet imaging criteria, and anticoagulant or dual antiplatelet use [9]. This example illustrates how stringent entry criteria directly limit recruitment capabilities.

Match Sites to Study Needs

Site selection should follow from protocol requirements instead of convenience or prior relationships. Evaluate each candidate site for investigator commitment, research infrastructure, patient volume, and competing trial activity. Industry-sponsored trial representatives in the Nordic countries identified site and investigator factors including access to patients, motivation, commitment, and resources as key determinants of recruitment success or failure [22]. A site with excellent facilities but low patient volume may underperform compared with a smaller site with strong community ties and dedicated research staff.

Forecast Recruitment with Multiple Methods

Recruitment forecasting should use more than one estimation method. Historical clinic data, electronic health record queries, disease registry counts, and prior trial enrollment rates each provide partial information. Electronic health records were the most important source of recruitment in 29 of 34 industry-sponsored trials discussed in a Nordic qualitative study [22]. However, identifying eligible patients still requires significant manual effort, and recruitment staff at ten university hospitals commonly used general office software because tailored recruitment systems were not available [23]. Combine quantitative estimates with qualitative input from clinicians who know the patient population.

Plan for Retention as Well as Enrollment

Feasibility assessment must address participant retention, also initial enrollment. Follow-up rates in feasibility studies vary widely. A pragmatic randomized trial of a brief alcohol intervention in Tanzania achieved 80 percent follow-up at six weeks, 82.7 percent at three months, and 84 percent at six months [7]. A pilot reimbursement study for women with breast cancer achieved 85 percent retention with 100 percent survey completion [10]. These rates reflect careful attention to participant burden and engagement. Assess whether the protocol's visit schedule, assessment battery, and follow-up procedures are acceptable to the target population.

Site Evaluation: Practical Steps

Step 1: Review Investigator Qualifications

Confirm that the principal investigator has relevant therapeutic expertise, prior trial experience, and protected time for research activities. Review the investigator's training records, including good clinical practice certification. Assess whether the investigator has a track record of completing trials and meeting enrollment targets. In general practice settings, physician attitude toward scientific research and awareness of the study influence recruitment success [24]. An investigator who is skeptical of the research question or unfamiliar with the protocol will struggle to enroll participants.

Step 2: Assess Staff Capacity

Research coordinator availability is often the limiting factor in trial execution. Determine whether dedicated coordinators exist, how many trials they currently support, and whether they have experience with the required procedures. Assess the availability of other personnel including study nurses, data entry staff, and laboratory technicians. Staff turnover during a trial can disrupt enrollment and data quality, so evaluate staff stability and institutional support for research positions.

Step 3: Verify Infrastructure and Equipment

Confirm that the site has the physical infrastructure required by the protocol. This includes examination rooms, procedure areas, equipment for specific assessments, and secure storage for investigational products and source documents. Verify laboratory capabilities, including whether tests can be performed on site or require referral to an external laboratory. The World Health Organization Laboratory Quality Management System Handbook provides guidance on the quality systems needed for reliable laboratory testing [1]. For trials involving biospecimens, the WHO Laboratory Biosafety Manual addresses safe handling and containment practices [2].

Step 4: Evaluate Institutional Support

Institutional commitment affects every aspect of trial conduct. Assess whether the institution has a clinical trials office, research administration support, and experience with the relevant regulatory framework. Determine the timeline for contract and budget negotiation, institutional review board approval, and other administrative processes. In the IMPROVISE stroke care study in India, one workstream explored the feasibility of establishing a multicentre ethics approval process within the Indian Stroke Clinical Trial network [16]. Delays in ethics approval can consume months of the trial timeline.

Step 5: Conduct a Site Visit

A site visit provides information that cannot be obtained from documents alone. Meet the research team, tour the facilities, and observe how patient flow operates in the clinical setting. Discuss the protocol with the staff who will actually perform study procedures. Ask about their concerns regarding feasibility, including workload, patient burden, and procedural complexity. The site visit is also an opportunity to assess the working relationship between the investigator and the research team.

Patient Recruitment Potential

Estimating the Eligible Population

Accurate estimation of the eligible population requires understanding both the disease epidemiology and the protocol's eligibility criteria. Start with the catchment area served by the site. Determine the number of patients with the condition of interest who receive care at the site. Query electronic health records using the protocol's inclusion and exclusion criteria to estimate the potential pool. In a multicenter cohort study linking electronic health records from five health systems, 5,051,187 patients were eligible based on broad criteria, but only 40,048 were invited to participate and 1,085 were enrolled [26]. This funnel illustrates the substantial drop-off between potentially eligible patients and actual enrollees.

Assessing Eligibility Criteria Impact

Every eligibility criterion reduces the potential participant pool. Evaluate each criterion for its impact on recruitment. In the cerebral amyloid angiopathy study, the most common reasons for exclusion were co-existent cognitive impairment or dementia, failure to meet imaging criteria, and anticoagulant or dual antiplatelet use [9]. The authors noted that more stringent entry criteria limit recruitment capabilities and that future trials need to consider how to define mild disease and manage comorbidities that could limit participation [9]. If the protocol requires a rare combination of characteristics, recruitment may be infeasible at a single site.

Selecting Recruitment Methods

Recruitment methods should be matched to the target population and the site's capabilities. Traditional in-person recruitment by study staff achieved the highest efficiency in a five-health-system study at 33.5 percent, followed by electronic messaging at 2.9 percent [26]. However, electronic messaging enrolled more participants overall and showed greater rates of recruitment of Black patients compared with other strategies [26]. Online recruitment has been shown to be significantly more effective with respect to recruitment rate for active days of recruitment, with all seven studies in a meta-analysis showing better online recruitment rates compared with offline recruitment [21].

Decentralized methods can also improve recruitment and retention. A systematic review of decentralized clinical studies found that eleven of thirteen studies reported improved recruitment using decentralized methods, with seven reporting improvements directly compared with traditional methods [20]. Virtual visits and remote data collection can reduce participant burden and expand the geographic reach of a trial.

Planning for Participant Diversity

Feasibility assessment should consider whether the planned recruitment methods will reach a representative population. Clinical trial participants rarely represent the real-world treatment population, potentially due to costs associated with participation [10]. Financial barriers include transportation, food, caregiver expenses, and out-of-pocket medical costs. A pilot study providing financial reimbursement of $1000 per month during the first four months of trial participation found that patients used the reimbursement for trial visit-related food, transportation, caregiver expenses, and out-of-pocket medical costs [10]. Patients felt that receiving reimbursement affected trial retention more than recruitment [10].

Using Technology to Support Recruitment

Electronic health records can support patient identification, but the practical implementation varies. In the Nordic industry-sponsored trial study, electronic health records were utilized in 29 of 34 trials discussed, and revision of legislation regulating secondary use of electronic health records was highlighted as the most effective measure to facilitate their use in recruitment [22]. Patient recruitment systems that integrate with electronic health records can reduce manual screening effort, but they require data from disparate sources to be made available and must be customized to user needs and the local environment [23].

Operational Considerations

Protocol Complexity and Visit Burden

Protocol complexity directly affects both recruitment and retention. Assess the number and length of study visits, the invasiveness of procedures, and the burden of patient-reported outcome measures. In a feasibility trial of a peer-group sports intervention for children with cerebral palsy in Brazil, the primary outcomes included willingness to participate, eligibility and recruitment rates, acceptability of screening procedures and random allocation, intervention adherence, and treatment satisfaction [12]. These feasibility measures address whether the intervention and its assessment schedule are acceptable to the target population.

Data Collection and Management

Evaluate the data collection systems proposed for the trial. Determine whether electronic data capture will be used, whether the site has the necessary hardware and internet connectivity, and whether staff are trained in the system. Assess the source data verification requirements and the availability of source documents. The Assay Guidance Manual from the National Center for Advancing Translational Sciences provides guidance on assay development and validation that is relevant for trials with laboratory endpoints [3]. For bioanalytical assays used in pharmacokinetic or biomarker assessments, the FDA Bioanalytical Method Validation Guidance describes the validation parameters expected for regulatory submissions [4].

Randomization and Blinding Procedures

Confirm that the randomization system is accessible and functional at the site. In the TRANSFoRm feasibility study, physicians could not access the result of the randomization at the end of each visit, which was identified as a usability issue [11]. Blinding procedures must be practical in the clinical setting. The ROBOCOP II feasibility trial comparing robotic-assisted and open partial nephrectomy used an open-label design because blinding was not feasible for surgical interventions [13].

Intervention Fidelity

For trials testing complex interventions, assess whether the intervention can be delivered as specified. In the ADAPT program for depressed parents of children with emotional and behavioral disorders, facilitators completed weekly treatment fidelity checklists, and the study found high program fidelity [15]. In the RecoverED delirium rehabilitation study, adherence to content was challenging to assess due to the intervention's personalized nature, and psychosocial support was delivered more frequently than planned [17]. Feasibility assessment should include plans for monitoring intervention fidelity and addressing deviations.

Feasibility Questionnaires and Tools

Purpose of Feasibility Questionnaires

Feasibility questionnaires are structured instruments used to collect standardized information from potential sites. They gather data on site experience, patient populations, equipment availability, staff capacity, and anticipated recruitment rates. Web-based multi-site feasibility questionnaire tools allow sponsors to collect and compare responses across multiple sites efficiently [28]. The analysis of feasibility study questionnaire responses helps sponsors identify sites that are likely to succeed and sites that may require additional support or training [29].

Designing a Feasibility Questionnaire

A well-designed feasibility questionnaire covers the domains described above. Include questions about the investigator's experience with the therapeutic area and with trials of similar design. Ask about the number of patients with the condition of interest seen at the site per month. Request information about competing trials that may affect recruitment. Ask about staff availability, including whether a dedicated research coordinator can be assigned to the study. Inquire about equipment and facilities required by the protocol. Ask about the site's experience with the proposed recruitment methods. Include questions about the site's timeline for regulatory approvals and contract execution.

Using Questionnaires in Site Selection

Feasibility questionnaires are a screening tool, not a substitute for site visits. Use questionnaire responses to identify sites that meet minimum criteria, then conduct site visits for the most promising candidates. Compare responses across sites to identify patterns and outliers. A site that reports an unusually high patient volume or an unusually fast approval timeline may warrant verification. The questionnaire analysis should be documented and retained as part of the feasibility assessment record.

Records and Measurements

Feasibility Metrics to Track

Feasibility assessment produces data that should be documented and tracked. Key metrics include the number of patients screened, the number eligible, the number enrolled, and the conversion rate from screening to enrollment. Recruitment rate is typically expressed as the average number of patients enrolled per month or per day of active recruitment [21]. Retention rate is the proportion of enrolled participants who complete the study or reach a specified follow-up point. In the reimbursement pilot study, feasibility was defined as 80 percent retention of patients on the reimbursement study, with those retained completing 75 percent of surveys [10].

Documenting the Assessment

The feasibility assessment should produce a written report that documents the evaluation process, findings, and recommendations. Include the protocol version reviewed, the sites assessed, the data sources used, and the assumptions underlying recruitment forecasts. Document any concerns identified and the actions taken to address them. The report should be updated if the protocol changes or if new information about site capacity becomes available.

Using Feasibility Data for Trial Planning

Feasibility data inform multiple aspects of trial planning. Recruitment forecasts determine the number of sites needed and the enrollment timeline. Site capacity data inform budget development, including staffing costs and infrastructure needs. Operational assessments identify training requirements and process improvements. The secondary results of feasibility trials are often used for planning confirmative trials, as in the ROBOCOP II trial where the secondary results will be used for planning a confirmative phase III trial if the primary outcome of recruitment feasibility is successful [13].

Common Failure Patterns

Overestimating Recruitment Rates

The most common feasibility failure is overestimating how many patients can be enrolled. Recruitment is the single biggest cause of trial delays, with around 80 percent of trials failing to meet their initial enrollment target and timeline [21]. Only approximately one third of all trials recruit their participants as planned [22]. Feasibility assessments that rely on optimistic assumptions about patient volume, eligibility rates, or conversion rates will produce unrealistic forecasts.

Underestimating Manual Screening Effort

Identifying eligible patients still requires significant manual effort at most sites [23]. Recruitment staff at ten university hospitals used general office software because tailored recruitment systems were not available [23]. Feasibility assessments should account for the staff time required to screen records, contact potential participants, and complete enrollment procedures. If the site lacks the staff capacity for this work, recruitment will fall behind schedule.

Ignoring Participant Burden

Protocols that impose excessive burden on participants will struggle with both recruitment and retention. Visit frequency, procedure invasiveness, and assessment length all affect participant willingness to enroll and continue. In the RecoverED study, most withdrawals were attributed to complex needs of the participants [17]. Feasibility assessment should include input from patients or patient representatives about the acceptability of the protocol procedures.

Neglecting Site Motivation

Investigator and staff motivation affects recruitment success. In general practice, factors including awareness of the study, attitude toward scientific research, perceived burden for the patient, time investment, and characteristics of the physician and practice influenced recruitment [24]. Sites that are not engaged with the research question or that perceive the study as burdensome will not prioritize enrollment. Feasibility assessment should evaluate site motivation and commitment, also capacity.

Failing to Plan for Retention

Trials that focus exclusively on enrollment without planning for retention will lose participants during follow-up. Retention planning should address participant communication, visit scheduling flexibility, reimbursement for trial-related costs, and strategies for maintaining engagement. In the reimbursement pilot study, patients reported that receiving reimbursement affected trial retention more than recruitment, with one patient stating that knowing the trial would not place a financial strain on the family made it easier to feel good about continuing [10].

Limitations of Feasibility Assessment

Uncertainty in Recruitment Forecasts

Even the most careful feasibility assessment cannot guarantee recruitment success. Recruitment forecasts are estimates based on available data and assumptions about future conditions. Changes in the clinical environment, competing trials, or referral patterns can affect recruitment rates. Feasibility assessments should include contingency plans for slower-than-expected recruitment, including additional sites, extended enrollment periods, or protocol amendments.

Single-Site Limitations

Feasibility data from a single site may not generalize to other sites. A single specialist centre study of cerebral amyloid angiopathy demonstrated that recruitment of a small pilot study was feasible from a single centre, but the authors noted that centralized multicentre research databases would allow for more effective and coordinated recruitment to larger studies [9]. Multi-site feasibility assessments should account for site-to-site variability in patient populations, staff capacity, and recruitment methods.

Resource Constraints

Feasibility assessment itself requires resources, including staff time for data collection and analysis. Small studies or studies with limited funding may not be able to conduct extensive feasibility assessments. In these cases, prioritize the highest-risk elements of the trial, typically patient recruitment and site capacity. A focused assessment of these domains is more valuable than a superficial assessment of all domains.

Evolving Regulatory and Ethical Requirements

Feasibility assessments are conducted at a point in time, and regulatory or ethical requirements may change before trial initiation. The IMPROVISE study in India explored the feasibility of establishing a multicentre ethics approval process within the Indian Stroke Clinical Trial network [16]. Feasibility assessments should note any regulatory uncertainties and plan for monitoring regulatory developments.

Safety and Regulatory Context

Participant Safety as a Feasibility Criterion

Participant safety is a fundamental feasibility consideration. A trial is not feasible if the site cannot safely conduct the required procedures or manage potential adverse events. In the single-port flexible robotic system trial for transoral head and neck surgery, the primary endpoint included conversion rates and perioperative complications within 30 days following surgery, and the study found no serious adverse events or adverse events related to the use of the robot [8]. Feasibility assessment should verify that the site has the capability to manage the expected safety profile of the intervention.

Laboratory Quality and Biosafety

Trials involving laboratory testing require appropriate quality systems. The WHO Laboratory Quality Management System Handbook provides a framework for implementing quality management in laboratories [1]. The WHO Laboratory Biosafety Manual addresses the safe handling and containment of biological materials [2]. Feasibility assessment should verify that the site's laboratory meets the quality and safety standards required by the protocol and applicable regulations.

Bioanalytical Method Validation

For trials with pharmacokinetic or biomarker endpoints, bioanalytical methods must be validated. The FDA Bioanalytical Method Validation Guidance describes the parameters for validating bioanalytical methods used in regulatory submissions [4]. The Assay Guidance Manual from the National Center for Advancing Translational Sciences provides guidance on assay development and validation [3]. Feasibility assessment should confirm that the site or its partner laboratories have validated methods in place or a plan for validation before trial initiation.

Literature and Evidence Review

Feasibility assessment should include a review of the relevant literature to understand the current evidence base and identify potential challenges. PubMed provides access to the biomedical literature, including feasibility studies and trial reports [6]. The National Center for Biotechnology Information provides literature resources including databases and tools for literature searching [5]. A literature review can identify prior feasibility studies of similar interventions or populations and inform the feasibility assessment.

Professional Escalation Criteria

When to Escalate Concerns

Feasibility assessment may identify concerns that require escalation to the sponsor, the institutional review board, or other oversight bodies. Escalate concerns that affect participant safety, data integrity, or the scientific validity of the trial. Examples include sites that lack the equipment or staff to perform required procedures, recruitment forecasts that fall far below the enrollment target, or protocol procedures that cannot be implemented as written.

When to Recommend Protocol Changes

Feasibility assessment may identify protocol elements that are impractical or that would prevent successful trial conduct. In these cases, recommend protocol changes before trial initiation. The cerebral amyloid angiopathy study noted that future trials will need to consider how best to define mild disease, factors that influence group heterogeneity, and the impact of comorbidities that could limit participation in multimodal testing, while being mindful that more stringent entry criteria will limit recruitment capabilities [9]. Protocol changes made during the feasibility phase are less costly than changes made after trial initiation.

When to Withdraw a Site

If a site cannot meet the requirements for safe and effective trial conduct, the site should not be selected or should be withdrawn from consideration. Indicators include lack of dedicated research staff, inadequate facilities, low patient volume, or unwillingness to commit the resources required for the trial. Site withdrawal during the feasibility phase is preferable to site failure during the trial.

When to Stop a Feasibility Study

Feasibility studies themselves may need to be stopped if they demonstrate that the main trial is not feasible. The ADAPT study concluded that an efficacy trial was warranted because a priori progression criteria were met and there was preliminary indication of efficacy [15]. Conversely, if progression criteria are not met, the feasibility study may conclude that the main trial should not proceed or should be substantially redesigned. Feasibility studies should define progression criteria in advance.

Frequently Asked Questions

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

A feasibility study asks whether the main trial can be done, while a pilot study tests the trial procedures on a small scale. Feasibility studies focus on questions such as whether participants can be recruited, whether the intervention can be delivered, and whether the outcome measures are appropriate. Pilot studies are often used to estimate parameters needed for sample size calculations. In practice, the terms are sometimes used interchangeably, and many studies combine feasibility and pilot objectives. The ROBOCOP II trial is described as a feasibility trial with the primary endpoint of feasibility of recruitment and secondary endpoints including perioperative results and health-related quality of life [13].

How many sites should be included in a feasibility assessment?

The number of sites depends on the trial's scope and the variability expected across sites. Single-site feasibility assessments can provide useful information for single-centre trials or for early evaluation of an intervention. Multi-site feasibility assessments are needed when the main trial will be conducted at multiple sites, because site-to-site variability in recruitment and operations can affect trial success. The IMPROVISE study in India was a multicentre feasibility study that implemented care bundles sequentially at three hospitals and explored implementation in four additional hospital sites [16]. The CONNECT trial is a multi-site randomized controlled pilot trial recruiting from 12 community oncology practices [18].

What are the most important questions to include in a feasibility questionnaire?

A feasibility questionnaire should cover site capacity, patient population, recruitment methods, operational readiness, and financial viability. Ask about the investigator's experience, the number of patients with the condition seen at the site, the availability of research staff, the equipment and facilities available, the site's experience with the proposed recruitment methods, and the timeline for regulatory approvals. The questionnaire should also ask about competing trials and any factors that might affect the site's ability to enroll and retain participants. Web-based multi-site feasibility questionnaire tools allow standardized data collection across sites [28].

How can recruitment rates be estimated before the trial starts?

Recruitment rates can be estimated using multiple methods. Query electronic health records to estimate the number of potentially eligible patients. Review disease registries and clinic databases for patient volume data. Examine prior trial enrollment rates at the site or at similar sites. Consider the impact of eligibility criteria on the potential participant pool. Combine these quantitative estimates with input from clinicians who know the patient population. In the Nordic industry-sponsored trial study, electronic health records were the most important source of recruitment, utilized in 29 of 34 trials discussed [22].

What retention strategies should be planned during feasibility assessment?

Retention planning should address participant burden, communication, and financial barriers. Assess whether the protocol's visit schedule and assessment procedures are acceptable to the target population. Plan for flexible visit scheduling and reminder systems. Consider reimbursement for trial-related costs including transportation, food, and caregiver expenses. In the reimbursement pilot study, patients used the reimbursement to pay for trial visit-related food, transportation, caregiver expenses, and out-of-pocket medical costs, and patients felt that receiving reimbursement affected trial retention more than recruitment [10].

How does decentralized trial design affect feasibility?

Decentralized methods can improve recruitment, retention, and diversity in clinical studies. A systematic review found that eleven of thirteen studies reported improved recruitment using decentralized methods, with seven reporting improvements directly compared with traditional methods [20]. Virtual visits and remote data collection can reduce participant burden and expand geographic reach. However, decentralized methods may not be suitable for all populations. In the TRANSFoRm study, patients felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies [11]. Feasibility assessment should evaluate whether the target population can use the proposed technology.

What should be done if feasibility assessment identifies recruitment problems?

If feasibility assessment identifies recruitment problems, address them before trial initiation. Options include modifying eligibility criteria to expand the potential participant pool, adding sites, implementing additional recruitment methods, or extending the enrollment timeline. The cerebral amyloid angiopathy study noted that more stringent entry criteria limit recruitment capabilities [9]. Protocol changes made during the feasibility phase are less costly than changes made after trial initiation. If recruitment problems cannot be resolved, the trial may not be feasible as designed.

How should feasibility findings be documented and reported?

Feasibility findings should be documented in a written report that includes the protocol version reviewed, the sites assessed, the data sources used, the assumptions underlying recruitment forecasts, and any concerns identified. The report should be updated if the protocol changes or if new information becomes available. Feasibility studies should be reported using appropriate reporting guidelines, and results should be made publicly available. The ROBOCOP II protocol states that results will be made publicly available in peer-reviewed scientific journals and presented at appropriate congresses [13].

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References and Further Reading

• Laboratory Quality Management System Handbook. World Health Organization.
• Laboratory Biosafety Manual. World Health Organization.
• Assay Guidance Manual. National Center for Advancing Translational Sciences.
• Bioanalytical Method Validation Guidance. U.S. Food and Drug Administration.
• NCBI Literature Resources. National Center for Biotechnology Information.
• PubMed. National Library of Medicine.
• Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania.. PloS one, 2023.
• Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery.. Oral oncology, 2019.
• Feasibility of clinical trial recruitment for cerebral amyloid angiopathy: A specialist single centre experience.. Journal of the neurological sciences, 2020.
• Financial reimbursement for clinical trial participation costs: a pilot feasibility study.. JNCI cancer spectrum, 2026.
• Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.. Family practice, 2016.
• Practitioner-led, peer-group sports intervention combined with a context-focused intervention for children with cerebral palsy: a protocol of a feasibility randomised clinical trial.. BMJ open, 2023.
• ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol.. BMJ open, 2021.
• Anti-epileptogenic clinical trial designs in epilepsy: issues and options.. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2014.
• Optimizing treatment for depressed parents of children with emotional and behavioral disorders: A multi-site feasibility trial.. 2026.
• Establishing collaborative partnerships to improve stroke care in India: a synopsis of IMPROVISE, a multi-site feasibility study. 2026.
• A rehabilitation intervention to improve recovery after delirium in older people: mixed methods process evaluation of the RecoverED multi-site feasibility study.. 2026.
• Multi-site feasibility of a web-based and telephone navigation intervention to connect lung cancer caregivers in community oncology settings with resources: Protocol for the WF-2301CD Caregiver Oncology Needs Evaluation Tool (CONNECT) trial.. 2026.
• A rehabilitation intervention to improve recovery after delirium in older people: Mixed methods process evaluation of the RecoverED multi-site feasibility study. 2025.
• Methods and perceptions of success for patient recruitment in decentralized clinical studies. Journal of Clinical and Translational Science, 2023.
• Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. Journal of Medical Internet Research, 2020.
• Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records-a qualitative interview study in the Nordic countries. Trials, 2022.
• Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals. JMIR Medical Informatics, 2021.
• Factors affecting patient recruitment to trials: qualitative research in general practice. BJGP open, 2020.
• A novel approach to conducting clinical trials in the community setting: utilizing patient-driven platforms and social media to drive web-based patient recruitment. BMC Medical Research Methodology, 2019.
• Patient Recruitment Into a Multicenter Clinical Cohort Linking Electronic Health Records From 5 Health Systems: Cross-sectional Analysis. Journal of Medical Internet Research, 2020.
• Benchmarking Patient Recruitment and Retention Practices. Therapeutic Innovation and Regulatory Science, 2020.
• Web-Based Multi-Site Feasibility Questionnaire Tool. Studies in Health Technology and Informatics, 2015.
• Clinical Trial Feasibility Study Questionnaire Analysis. Studies in Health Technology and Informatics, 2015.
• Pilot Study to Assess the Feasibility of Using Sexual Function and Vaginal Changes Questionnaire in Gynaecological Cancer Survivors. Indian Journal of Gynecologic Oncology, 2018.
• Feasibility and reliability of a questionnaire to assess the mode, frequency, distance and time of commuting to and from school: The paco study.. International Journal of Environmental Research and Public Health, 2020.

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