A peer-reviewed clinical utility study
Randomized, simulated-patient design. IRB-approved, PI-led, registered where the design calls for it, and written for the journals that adoption committees, reviewers and payers read.
For life science, diagnostics, and devices
What will clinicians actually do with your technology? We can tell you in weeks, not years.
Clinical utility studies and physician decision-making research for diagnostics, devices and therapeutics. Practicing clinicians work through the exact clinical scenarios your technology is meant to inform. We quantify the decisions they make with and without it, and deliver the result as a publishable study, a strategy briefing, or both.
What we measure
The clinical decision
Practicing physicians care for simulated patients built around the clinical judgments your technology informs or sits downstream of. We measure what they order, which interventions they choose, and how they escalate using standard-of-care tools. Then we introduce your technology and measure the difference. Because the cases are held constant, the only variable is your technology’s output. That isolates your product’s effect in a way patient-level data cannot, at a fraction of the cost and time.
Where this fits
Your technology works. Does it change what physicians do?
The fit is strongest when your technology helps physicians route the right patients into care paths with established benefit. Where the right decision already has a proven outcome, the open question is whether physicians make it more often.
- Diagnostics and monitoring technologies seeking evidence for payer or health system adoption
- Early-stage companies that need evidence of impact before a definitive trial is possible
Two deliverables
Evidence you can publish, insight you can act on
Decision-making and market research
How physicians across specialties and settings would use, order, interpret and act on your technology in defined clinical scenarios, delivered as data and a briefing to guide your internal strategy.
Many engagements do both from one study.
Why simulated patients
Quickly gather clean clinical decision data from practicing physicians across the country
Because the patients are simulated, see how real physicians from across the country care for the same patients with and without your technology. Simulated patients measure decisions directly rather than by self-report, control the case mix, allow randomization, and produce the effect sizes that reviewers and payers ask for.
How simulated-patient RCTs compare with other evidence paths
| Approach | What it tells you | Where it falls short |
|---|---|---|
| Physician survey | Physicians’ opinion on the potential impact of the technology. | Investors, reviewers and payers typically discount it, because abstract survey opinions are not validated or linked to relevant clinical scenarios. |
| Retrospective claims or chart review | Historical data on how practice has changed with existing technologies. | Confounded by who adopts. Requires existing real-world adoption, one of the main challenges for early-stage innovators. |
| Prospective clinical trial | Patient outcomes under controlled conditions. | Years and millions of dollars, and it may still not isolate the decision your technology informs. |
| Simulated patient RCT | What practicing physicians actually decide, with and without your results. Identifies the use cases with the greatest effect, to focus strategy, dissemination and future studies. | Measures physician decisions with established links to patient outcomes, not the outcomes themselves. |
Published clinical utility evidence
Randomized trials that stand up to peer review
The randomized design behind our studies, simulated patients cared for by practicing physicians, has been the foundation of more than 20 peer-reviewed publications across a range of specialties and use cases.
Clinical utility research Randomized virtual trial, conference abstract
Impact of a blood-based biomarker on neurologist diagnostic decision-making for Alzheimer's disease: a randomized virtual trial
142 board-certified neurologists cared for 852 simulated patients. With access to a p-tau217/amyloid-beta 1-42 blood biomarker, diagnostic concordance with expert-defined diagnoses in mild and early Alzheimer's disease improved by 26.2 percentage points (P=.007), while PET and CSF ordering fell by 23.9 percentage points: better decisions and less downstream utilization in one study.
Alzheimer's Association International Conference, 2026
Full manuscript in development. Trever Burgon is principal investigator, of record with the IRB and on ClinicalTrials.gov.
Das L, Burgon T, Bhatt K, Ferrara KG, Paculdo D, De Belen E, Valdenor C. Presented at the Alzheimer's Association International Conference, July 2026, London.
Clinical utility research Randomized controlled trial
Helping primary care providers recognize and respond to medication non-adherence and drug-drug interactions: A randomized-controlled clinical utility trial in a value-based care setting
139 primary care providers in a large multi-state practice cared for simulated patients with chronic disease; half had results from a saliva-based test for medication non-adherence and drug-drug interactions. With the test, correct diagnosis of non-adherence rose from 10% to 80% and of drug interactions from 19% to 53%, with matching gains in appropriate treatment.
With Aegis Sciences Corporation, Wayne State University School of Medicine
PLOS ONE, 2026
Burgon T, Paculdo D, Schrecker J, Ferrara KG, David RE, Johnson S, Valdenor C, Peabody J. PLoS One. 2026;21(3):e0344906. doi:10.1371/journal.pone.0344906
Clinical utility research Randomized controlled trial
A Randomized Controlled Study on Clinical Adherence to Evidence-Based Guidelines in the Management of Simulated Patients With Barrett's Esophagus and the Clinical Utility of a Tissue Systems Pathology Test: Results From Q-TAB
A three-arm randomized trial among 259 practicing gastroenterologists and GI surgeons caring for simulated patients with Barrett's esophagus. Physicians given a tissue systems pathology (TSP-9) result were more likely to assess the risk of progression correctly and treat in line with US guidelines (+6.9%), and far more likely to follow annual endoscopic surveillance where it was indicated (+18.5%).
With Castle Biosciences
Clinical and Translational Gastroenterology, 2024
Peabody JW, Cruz JDC, Ganesan D, Paculdo D, Critchley-Thorne RJ, Wani S, Shaheen NJ. Clin Transl Gastroenterol. 2024;15(1):e00644. doi:10.14309/ctg.0000000000000644
Clinical utility research Randomized controlled trial
Clinical Utility of a Biomarker to Detect Contrast-Induced Acute Kidney Injury During Percutaneous Cardiovascular Procedures
A two-round randomized trial among 154 interventional cardiologists caring for simulated patients at risk of contrast-induced kidney injury. Physicians given a urine L-FABP result improved their care by 4.6% over controls, were 2.9 times more likely to identify a patient's risk correctly, and more than twice as likely to treat it, with the greatest value before and during the procedure.
With Hikari Dx
Cardiorenal Medicine, 2022
Peabody J, Paculdo D, Valdenor C, McCullough PA, Noiri E, Sugaya T, Dahlen JR. Cardiorenal Med. 2022;12(1):11-19. doi:10.1159/000520820
Clinical utility research Randomized controlled trial
Finding the Clinical Utility of 1,5-Anhydroglucitol Among Primary Care Practitioners
A randomized trial among 145 primary care physicians caring for simulated patients with diabetes and short-term swings in glucose control. Physicians given a 1,5-anhydroglucitol result scored 3.2% higher on overall quality than controls, with nearly all of the gain in patients whose high glucose was caused by a medication, where scores rose 8.1%.
With Hikari Dx
Journal of Clinical & Translational Endocrinology, 2020
Read the paper: Finding the Clinical Utility of 1,5-Anhydroglucitol Among Primary Care Practitioners
Peabody J, Paculdo D, Acelajado MC, Burgon T, Dahlen JR. J Clin Transl Endocrinol. 2020;20:100224. doi:10.1016/j.jcte.2020.100224
Clinical utility research Review
Establishing Clinical Utility for Diagnostic Tests Using a Randomized Controlled, Virtual Patient Trial Design
The methods paper: four randomized virtual-patient trials of diagnostic tests, each with the same two-round control and intervention design. Two showed clinical utility across the intended population and two in a sub-segment of it, and two of the tests went on to positive Palmetto coverage decisions. The reference for anyone asking whether the design is sound.
Diagnostics (Basel), 2019
Peabody J, Tran M, Paculdo D, Valdenor C, Burgon T, Jeter E. Diagnostics (Basel). 2019;9(3):67. doi:10.3390/diagnostics9030067
Clinical utility research Randomized controlled trial
Impact of a protein-based assay that predicts prostate cancer aggressiveness on urologists' recommendations for active treatment or active surveillance: a randomized clinical utility trial
129 board-certified urologists cared for simulated patients with newly diagnosed early-stage prostate cancer. Those given a protein-based assay that predicts tumor aggressiveness were significantly more likely to recommend the preferred course, active surveillance or active treatment (p = 0.004), and to involve the patient in the decision.
With Metamark Genetics
BMC Urology, 2017
Peabody JW, DeMaria LM, Tamondong-Lachica D, Florentino J, Czarina Acelajado M, Ouenes O, Richie JP, Burgon T. BMC Urol. 2017;17(1):51. doi:10.1186/s12894-017-0243-1
How we run a Veradence Health study
Four phases, from kickoff to dissemination
Design
Kickoff, and case development in two to three iteration rounds with your team. Regulatory submissions where the design calls for them: IRB review, and ClinicalTrials.gov registration for trials.
Data gathering
Recruitment and study administration, run concurrently. Practicing physicians in the target specialty and setting, typically 50 to 150, each paid an honorarium. Each cares for six to eight simulated patients.
Findings
Analysis and reporting. Topline about one week after data close; the full report after. Difference-in-differences and pre-post analysis, with each physician as their own control.
Dissemination
Abstract or manuscript drafted, reviewed and submitted, for the Pilot and Trial options.
What makes a Veradence Health study different?
- Speed
- Data gathering begins within weeks, topline results arrive within months, and an abstract or manuscript follows in six to eight.
- Care decisions
- Participants care for patients as they would in their practice, making decisions about work-up, diagnosis and treatment. Not an opinion survey.
- Validation
- This case-based approach to measuring practice has been validated in more than 20 peer-reviewed papers.
- Randomized, IRB-approved design
- Physicians are randomized to intervention and control arms, cases across arms and rounds, and IRB approval is complete before recruitment begins, so the results are publishable.
- Clean comparisons
- Physicians receive no feedback during the study, and the second round uses new cases matched to the first, so recall and learning cannot explain the change.
- Built around your use cases
- Cases are developed to match the use cases most important to you, so you quickly see the care paths where your technology excels and where it may struggle to change practice.
Three study options
The same engine, tuned to the evidence you need
The same case-building and measurement engine underpins all three. The options differ in design, output and timeline, matched to your commercialization stage.
Practice Assessment
Guides internal strategy
- Design
- Single arm, pre and post
- What it answers
- How are physicians managing these patients today, and do their decisions shift once your data is in hand?
- Output
- Analytic report and slide summary
- To results
- About 9 weeks
- With abstract or manuscript
- Not applicable
Clinical Utility Pilot
Supports investor and partner conversations
- Design
- Randomized, control and intervention arms
- What it answers
- Does your technology change decisions relative to a concurrent control group?
- Output
- Analytic report and a conference abstract
- To results
- 18 to 20 weeks
- With abstract or manuscript
- 22 to 24 weeks
Clinical Utility Trial
Built for external visibility and payer review
- Design
- Randomized and powered, IRB-approved, registered
- What it answers
- The same question, at a standard that supports peer review and payer submission.
- Output
- Analytic report and full manuscript for peer review
- To results
- 23 to 26 weeks
- With abstract or manuscript
- 29 to 32 weeks
What you get
Results you can share with future users, a payer or a board
- Effect sizes on specific decisions: the orders, interventions and referrals that move, and by how much.
- Downstream utilization effects: how physicians’ ordering patterns affect expected costs.
- Sub-analyses that matter commercially: the clinical scenarios where the effect is largest, and where it may be smaller or absent.
- Physician characteristics: which traits, such as age, practice setting and geography, are most closely associated with adoption and clinical utility.
- A publishable dataset, when scoped and properly powered, with IRB approval and ClinicalTrials.gov registration.
Who this is for
Teams that need evidence of clinical utility
- Medical affairs
- Clinical development
- Health economics and outcomes research
- Market access and reimbursement
- Commercial strategy and marketing insights
- Diagnostics, device and pharma companies at any stage
What would you do with a clear view of how physicians decide, with and without your technology?
Let’s spend thirty minutes on the decision your technology informs, the evidence you need, and which study option fits.