Finding people with metabolic risk factors is not the same as finding people eligible for a MASH clinical trial. A site may have established relationships with adults living with obesity, type 2 diabetes and fatty liver disease, but the protocol may require a particular fibrosis stage, documented treatment history, specific test methods and visits that are difficult to accommodate.
For sponsors and CROs evaluating MASH and NASH trial sites in Florida or Puerto Rico, the central feasibility question is whether the team can turn an appropriate clinical lead into a confirmed, consented and correctly assessed participant. That requires a patient-identification plan and an equally credible assessment pathway.
Start by defining the protocol population precisely
Terminology matters, but eligibility matters more. MASLD is the newer name for metabolic dysfunction-associated steatotic liver disease; MASH corresponds to the inflammatory form previously called NASH. FDA has explained that the NASH and MASH terms are interchangeable in its technical clinical-trial data guidance, even while some older materials retain the former terminology.
A patient recorded as having fatty liver does not automatically meet a MASH protocol. Some studies focus on people with noncirrhotic disease and a specified degree of fibrosis, while others evaluate different stages, comorbidities or outcomes. Sponsors should identify the criteria that truly determine enrollment before asking any site for a number.
A useful feasibility response distinguishes documented diagnosis, suspected disease, available fibrosis information, necessary clinical confirmation and criteria that can be evaluated only at protocol screening. If these categories are combined, the forecast can look more precise than the underlying evidence.
Build a patient-identification funnel with evidence at every step
A defensible approach starts with the actual clinical sources: primary-care and metabolic-disease practices, gastroenterology or hepatology referrals, available records and other established relationships. Then it narrows the list based on relevant information rather than counting everyone with obesity, diabetes or an elevated liver enzyme.
The National Institute of Diabetes and Digestive and Kidney Diseases describes how history, laboratory testing, imaging and sometimes biopsy contribute to evaluating fatty liver disease. None of these elements should be treated as a universal shortcut to trial eligibility. For example, a diagnosis code may be dated, a fibrosis score may use laboratory results collected months apart, and an imaging report may not answer a protocol-specific question.
During feasibility, ask how many records have usable dates, how many need clinician review, how patients may be contacted appropriately and what proportion could realistically reach a consent discussion during the enrollment window. A small, well-supported estimate is more useful than a large unscreened list.
Separate clinical risk stratification from protocol-required testing
In routine care, tools such as FIB-4, elastography and other noninvasive tests help clinicians evaluate fibrosis risk and determine whether further assessment is warranted. The AASLD has described a stepwise approach that may use FIB-4 first, followed by additional testing or specialist referral when indicated. These clinical tools help identify people worth evaluating; they do not automatically satisfy a specific trial protocol.
The sponsor must state exactly what the protocol accepts, including test type, thresholds, permitted intervals, required central review, repeat testing and whether histology is needed. FDA has discussed vibration-controlled transient elastography as a proposed biomarker for clinical trials, but acceptance of a qualification letter of intent is not the same as universal qualification or permission to substitute it for every protocol endpoint.
The operational test is whether those assessments can be completed, reviewed and acted upon before the screening window closes. A site can have excellent patient access and still be a poor fit if a necessary test is unavailable at the required time.
Verify the complete assessment and referral pathway
A capable site should be able to explain where each protocol-required procedure occurs, who orders it, how appointments are obtained, who reviews results and how the research team receives documented findings. Do not assume that access to ordinary ultrasound, MRI or laboratory services establishes access to protocol-specified liver stiffness testing, MRI-PDFF, MRE or liver biopsy.
The feasibility conversation should explicitly document the following dependencies before the projected first screening visit:
- Who provides specialized imaging or elastography, and whether its technology and calibration meet the protocol.
- Whether required laboratory tests can be performed locally or must use a central laboratory, including turnaround times and repeat-sample rules.
- Who handles any necessary specialist consult, biopsy, pathology shipment and independent reads, if those procedures are required.
- Who is responsible for scheduling, results transfer, source documentation, patient questions and adverse-event escalation.
- How the site handles an indeterminate result or a required second test without losing the allowed screening window.
Measure referral reliability, not just referral relationships
A physician referral relationship is valuable when responsibilities are clear. Sponsors should ask whether the referring clinicians recognize the relevant eligibility features, whether a research team may contact a referred person under the applicable permissions and how candidates move from clinic care to research prescreening.
Consider the practical sequence: a physician identifies someone with risk factors, the study team checks available information, the investigator decides whether outreach is appropriate, the potential participant receives accurate study information, and the site arranges any needed pre-screening or screening activities. Each handoff takes time and has a responsible owner.
The distinction is especially important where patients receive routine care at one practice and research procedures occur elsewhere. The location of research visits, specimen processing, imaging and follow-up should be clear to both the sponsor and the participant before consent.
Budget for the visit burden that eligibility creates
Some MASH protocols require repeated blood draws, fasting appointments, imaging, extended visits, medication checks, dietary or lifestyle documentation and prolonged follow-up. A technically eligible participant may not be available for that schedule. Feasibility should therefore include scheduling capacity and the realities of repeated attendance, rather than stop at a clinical yes-or-no screen.
Ask which activities require an early-morning appointment, which must occur in a fixed order and whether a specialist assessment could lengthen a visit or require a separate trip. Confirm participant communication in the preferred language, the reimbursement terms permitted by the protocol and IRB, and coverage during staff absences.
Nearby studies and competing appointment needs also matter. Two metabolic programs might draw from overlapping patient groups even when their indications differ. WCR's feasibility and startup approach uses protocol requirements, available patient information, local trial activity and team review to help distinguish theoretical access from executable capacity.
A sponsor and CRO decision worksheet
Before adding a MASH or NASH research site, request a written answer to six practical questions. The point is not to impose a rigid scoring system. It is to expose uncertainties that could affect first screening and sustained enrollment.
- Population: What is documented, what is merely suspected, and which key exclusions remain unknown?
- Assessments: Which fibrosis, imaging, laboratory or histology requirements can be met within the specified windows?
- Clinical review: Who determines referral suitability, evaluates contradictory findings and confirms protocol alignment?
- External dependencies: Which procedures depend on outside providers, shipping, central reads or specialist availability?
- Participant flow: What happens from first contact through consent, screening, randomization and follow-up?
- Capacity: What is the realistic appointment volume after competing trials, staff coverage and visit burden are considered?
What WCR can evaluate in Miami Lakes and Puerto Rico
Wellness Clinical Research operates a coordinated network in South Florida and Puerto Rico with clinical relationships relevant to metabolic health, including obesity, diabetes and cardiovascular risk. Its published metabolic-disease research capabilities describe multispecialty feasibility review, clinical sample processing, temperature-controlled storage, bilingual communication and coordinated site operations.
These capabilities support an informed protocol discussion, not an assumption that every MASH-specific assessment is available on-site. For a proposed study, the team should first confirm investigator fit, access to the appropriate clinical population, required testing and any qualified external providers, before making an enrollment commitment.
WCR's published obesity-related case studies provide examples of study-specific recruitment preparation and operational follow-through. They should not be presented as proof of enrollment performance in a different MASH or NASH protocol.
Make the final feasibility estimate conditional and auditable
A credible site response should name the evidence supporting its forecast and the assumptions that could change it. It should separate potential candidates, patients who can be contacted, people likely to accept screening, those who complete the required assessments and those who ultimately satisfy every protocol criterion.
When a critical referral or imaging pathway has not yet been confirmed, say so. Sponsors and CROs can then solve the dependency before activation rather than discover it through avoidable screen failures and missed appointments.
To evaluate a MASH or NASH protocol with Wellness Clinical Research, sponsors and CROs can start with the existing Submit a Study page and identify the required assessment methods, patient population and study timeline.