For research sites

Clinical trial feasibility counted before you commit to the study.

Clinical Extract counts the eligible patients in your own EHR against the sponsor's criteria, so you answer the feasibility questionnaire with real numbers before you sign on.

One count across your EHRs, affiliate instances included.

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1 The funnel

Site feasibility for clinical trials from coded criteria.

Each protocol criterion runs as a coded criterion on data from your EHR: a diagnosis code set, a lab value inside a window, a medication, a stage, an encounter date range. The count after each step comes back before a chart is opened, and the sponsor's feasibility questionnaire gets a count and the criteria that produced it. With a clinical trial feasibility tool that reads your own EHR data, your coordinators report a count instead of an estimate.

The count is preparatory to research: no record leaves the EHR for it. When the study starts, the same criteria become the cohort the export runs on.

Feasibility funnelA trial protocol’s criteria applied in order, each with its coded source and an illustrative patient count. Population, seen 2021 to 2025 at any site, from Encounter.period: 48,210 patients, drawn as a broken bar. Inclusion 1, breast cancer, Condition.code in ICD-10-CM C50.x: 1,904, 3.9% of the step before. Inclusion 2, ER positive and HER2 negative, Observation LOINC 16112-5 and 48676-1: 1,112, 58%. Inclusion 3, stage II or III at diagnosis, Observation LOINC 21908-9: 640, 58%. Exclusion 1, tamoxifen before diagnosis, MedicationRequest RxNorm 10324: 612 eligible, 96%, highlighted.05001,0001,5002,000patients; the first bar is brokenPOPULATIONseen 2021 to 2025, any siteEncounter.period48,210INCLUSION 1breast cancerCondition.code, ICD-10-CM C50.x1,9043.9% keptINCLUSION 2ER positive, HER2 negativeObservation, LOINC 16112-5, 48676-11,11258% keptINCLUSION 3stage II or III at diagnosisObservation, LOINC 21908-964058% keptEXCLUSION 1no tamoxifen before diagnosisMedicationRequest, RxNorm 1032461296% kepteligible
Feasibility funnelA trial protocol’s criteria applied in order, each with its coded source and an illustrative patient count. Population, seen 2021 to 2025 at any site, from Encounter.period: 48,210 patients, drawn as a broken bar. Inclusion 1, breast cancer, Condition.code in ICD-10-CM C50.x: 1,904, 3.9% of the step before. Inclusion 2, ER positive and HER2 negative, Observation LOINC 16112-5 and 48676-1: 1,112, 58%. Inclusion 3, stage II or III at diagnosis, Observation LOINC 21908-9: 640, 58%. Exclusion 1, tamoxifen before diagnosis, MedicationRequest RxNorm 10324: 612 eligible, 96%, highlighted.POPULATIONseen 2021 to 2025, any siteEncounter.period48,210INCLUSION 1breast cancerCondition.code, ICD-10-CM C50.x1,9043.9% keptINCLUSION 2ER positive, HER2 negativeObservation, LOINC 16112-5, 48676-11,11258% keptINCLUSION 3stage II or III at diagnosisObservation, LOINC 21908-964058% keptEXCLUSION 1no tamoxifen before diagnosisMedicationRequest, RxNorm 1032461296% kept01,0002,000patients; the first bar is broken
Figure 1 as a table
Protocol criterionCoded sourcePatientsKept
Population: seen 2021 to 2025, any siteEncounter.period48,210
Inclusion 1: breast cancerCondition.code, ICD-10-CM C50.x1,9043.9%
Inclusion 2: ER positive, HER2 negativeObservation, LOINC 16112-5 and 48676-11,11258%
Inclusion 3: stage II or III at diagnosisObservation, LOINC 21908-964058%
Exclusion 1: tamoxifen before diagnosisMedicationRequest, RxNorm 10324612 eligible96%
Figure 1. Feasibility funnel. Each protocol criterion runs as a coded criterion on data from your EHR, and the count after every step comes back before a chart is opened. The sponsor’s feasibility questionnaire gets each count with the criteria that produced it. Bars are to scale except the first, which is broken. Counts are illustrative.

2 Across your EHRs

One count across a physician network.

A network runs more than one EHR. Clinical Extract connects to each through its certified bulk FHIR API, runs the same criteria on every one, and returns one count, split by site. An Epic Community Connect affiliate is counted through the host organization's Epic and split out by the organization on each encounter; the Epic page covers how the host activates the app once for its affiliates.

One count across your EHRsA research network on three EHRs. A medical center, the host, and an affiliate clinic on Epic Community Connect both keep their records in the host’s Epic. A community hospital runs MEDITECH and a physician group runs athenahealth. Each EHR, in your environment, connects through its certified bulk FHIR API with read scopes to Clinical Extract, inside the same environment, which runs the criteria from Figure 1 on each and rolls the counts up: Epic, medical center and affiliate, 389, split by the encounter’s organization into 301 at the medical center and 88 at the affiliate clinic; MEDITECH 141; athenahealth 82; one network count of 612, highlighted.YOUR ENVIRONMENTNETWORK SITESMedical centerthe hostAffiliate clinicon Epic Community Connect,records in the host’s EpicCommunity hospitalPhysician groupEpichost organizationcertified bulk FHIR APIMEDITECHcertified bulk FHIR APIathenahealthcertified bulk FHIR APIread scopesread scopesread scopesClinical Extractruns the criteriaELIGIBLE, BY EHREpic389medical center301affiliate clinic88MEDITECH141community hospitalathenahealth82physician groupOne count612criteria of Figure 1
One count across your EHRsA research network on three EHRs. A medical center, the host, and an affiliate clinic on Epic Community Connect both keep their records in the host’s Epic. A community hospital runs MEDITECH and a physician group runs athenahealth. Each EHR, in your environment, connects through its certified bulk FHIR API with read scopes to Clinical Extract, inside the same environment, which runs the criteria from Figure 1 on each and rolls the counts up: Epic, medical center and affiliate, 389, split by the encounter’s organization into 301 at the medical center and 88 at the affiliate clinic; MEDITECH 141; athenahealth 82; one network count of 612, highlighted.YOUR ENVIRONMENTCERTIFIED BULK FHIR API, READ SCOPESEpicmedical center, the hostaffiliate clinic on EpicCommunity Connect, via the hostMEDITECHcommunity hospitalathenahealthphysician groupClinical Extractruns the criteria on each EHRELIGIBLE, BY EHREpic389medical center301affiliate clinic88MEDITECH141community hospitalathenahealth82physician groupOne count612criteria of Figure 1
Figure 2 as a table
EHRSitesEligible
EpicMedical center (host)301
EpicAffiliate clinic on Epic Community Connect88
MEDITECHCommunity hospital141
athenahealthPhysician group82
NetworkAll four sites, same criteria612
Figure 2. One count across your EHRs. Clinical Extract connects to each EHR in the network through its certified bulk FHIR API, runs the same criteria on every one, and returns one feasibility count. An Epic Community Connect affiliate is counted through the host organization’s Epic and split out by the organization on each encounter. Counts are illustrative and match Figure 1.

3 From the count to the study

The same criteria define the study cohort and its export.

Once the site signs on, building the cohort from the same criteria gives the study its Group, and the export returns an analysis-ready CSV and its data dictionary for your EDC or eSource system to import. No one retypes the data. Recruiting the patients the count found is a different job, and our guide to EHR data in clinical research covers it.

We also build OMOP pipelines.

4 Questions

Questions from research sites

What is a clinical trial feasibility assessment?

The sponsor’s question to a site before the study starts: how many of your patients meet the protocol’s criteria, and how fast could you enroll them. Clinical Extract answers the first half with a count from your own EHR, with each criterion’s definition next to its count.

What goes into a feasibility count?

The protocol’s inclusion and exclusion criteria as coded criteria: a diagnosis code set, a lab value inside a window, a medication, a stage, an encounter date range. Each one runs on data from your EHR, and you see the count after every step before any chart is opened.

How fast is a count?

Minutes for a site, because the criteria run on coded data through the certified bulk FHIR API. A network gets one count across every EHR, split by site.

Does it count Epic Community Connect affiliates?

An affiliate is counted through the host organization’s Epic and split out by the organization on each encounter, so the network’s count includes it alongside the sites that run their own EHR.

What does the sponsor get?

A number with its definition: the eligible count, the criterion set that produced it, and the date. When the study starts, the same criteria become the cohort the export runs on, and your EDC imports the CSV and its data dictionary.

Next

See Clinical Extract run on one of your studies.

Tell us which EHR you run and what the study or registry needs. We reply within one business day to set a meeting time.

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