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Setting Clinical Research to FHIR

Geoff Low, Medidata Solutions

Schedule of Activities

• What is a Research Trial?

• What do we need to consider for data collection in a clinical trial?

• How can we use Healthcare Data in Research?

Pharmaceutical Industry

• Sales worth ~ $1.1 tn (2017)

• Eroom's law

• drug discovery is becoming slower and more expensive over time, despite improvements in technology

• Drugs typically take 12 years to get to market ~ £1.15bn to get to market

https://www.statista.com/statistics/263102/pharmaceutical-market-worldwide-revenue-since-2001/

What is a trial?

An investigation or experiment to prove an intervention is both:

• SAFE

• EFFICACIOUS

• Two main types: • Clinical Trial

• Observational Study

• We need data (and lots of it)

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The Clinical Trial Protocol

• Design document for a study

• Defines the key criteria for a clinical study, including:

• Key Study Criteria (Intervention, TA, etc)

• Arms

• Endpoints/Outcomes

• Study Procedures

• Analysis

• Submitted as part of the Approval Process to the regulatory bodies

• IRB, FDA

Example 1: Eligibility Criteria

Key to being able to run a clinical trial we need subjects

• Inclusion Criteria - set of Criteria which prospective participants must* match

• Exclusion Criteria - set of Criteria which prospective participants must not* match

* There is often discretion

Inclusion Criteria

• Male or female patients with a diagnosis of Pulmonary Arterial Hypertension (PAH); or inoperable, persistent or recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH),

• Age ≥ 18 years, • Baseline 6 Minute Walk Distance (6MWD) a

minimum of 250 meters or maximum 450 meters, (ensure significant Pulmonary Hypertension(PH) without limiting their participation in the trial)

• WHO Functional Class II or III,

Exclusion Criteria

• Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band),

• Medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator,

• Enrolled in pulmonary rehabilitation program within last 6 months,

• Participating in an interventional study.

Exercise 1: Implementing Eligibility Criteria

“Age ≥ 18 years”

“Male or Female”

“diagnosis of Pulmonary Arterial Hypertension (PAH)”

“inoperable, persistent or recurrent

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)”

Hypersensitivity to nickel (present in the clasp of the FitBit Flex's band)

Patient?birthdate=ge2018-06-01

Patient?gender=female,male

Condition?code=697898008

Condition?code=233947005

AllergyIntolerance?code=419788000

OR AND

NOT

Code Break

https://github.com/glow-mdsol/devday-boston-clinical-research

Eligibility

Cost of patient enrollment

Approximately 29% of clinical trials cost is attributed to the enrollment process

• Identification of subjects

• Screening of subjects

Automated identification and pre-screening of subjects could save

~ $37k per day

The FHIR Resources

• Initiated as part of the Structured Data Capture (SDC) Work stream

• Under the purview of the Biomedical Research and Regulatory (BR&R) Group

• Amalgamation of the RCRIM and BRIDG working groups

ResearchStudy

• Used to record information about a clinical experiment

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Uses for ResearchStudy

• Study Registration

• Finding Studies for candidate Patients

• Subject Registration

POST ResearchStudy

GET ResearchStudy?condition=

697898008

POST ResearchSubject

Code Break

https://github.com/glow-mdsol/devday-boston-clinical-research

researchstudy

ResearchSubject

• Links a Patient to a ResearchStudy

• Includes arm allocation information

• Important for Subject Path

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Uses for ResearchSubject

• Subject registration

• Searching for research subjects

• Reference for Study Data

ResearchSubject (POST)

ResearchSubject?study=ResearchStudy/1234 (GET)

Data Capture

• Collection of requisite data for support of data analysis to match clinical outcomes

Data Capture – the old way

• Data was written into a NCR paper form

• One part kept, one sent to data entry

• Issues are raised through reports or data validation

• Sent to Site for reconciliation

• Investigator signs off data as collected

Data Capture – the current way

Electronic paper.....

Still transcribing from notes….

Source Data Verification

The Case Report Form

https://medical-data-models.org/28832

Code Break

https://github.com/glow-mdsol/devday-boston-clinical-research

population

eSource

"All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).” – EMA 2010

"Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” – FDA 2013

eSource – the value proposition

Data designated as eSource does not require Source Data Verification

• Between 15% (PI) and 3% (PIII) cost of a clinical study is spent on SDV

Significant streamlining of costs and time for delivery of final trial data; less cost and quicker to market

Data Capture – the future way

A patient-centered record

distributed across one or more

healthcare systems, available for

analysis in one or more studies.

Healthcare Data in Research

SOC

CR

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Initiatives

• Transcelerate

• eSource Working Group

• FHIR Connectathons

• CDISC • EHR TO CDASH (E2C) project

• Participation in IHE Projects

Working Initiatives

• Updates and examples for Research Resources

• EHR TO CDASH (E2C) project to BRIDG semantics between healthcare and research

• Integrating Lab data from using the CDISC LAB model

• Integrating FHIR healthcare data into CRFs

• Evaluating the PlanDefinition/Argonaut Scheduling initiatives for exchanging study activities with Healthcare Systems