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CDISC © 2010

CDISC © 2010

Disease Specific Data Standards: Case Studies in TB and Cardiology

CDISC Japan Interchange

20 July 2010

Bron [email protected]

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• Why disease-specific standards?

• TB & Cardiology Projects

• Controlled Terminology

• New Disease Projects

Presentation Outline

CDISC © 2010

Clinical Data Element: Angina

3

Industry(Pharma, CROs)

Regulators(FDA, PFDA,

EMA)Patient Care

(EHR Systems)

NIH & Academia

ComparativeEffectiveness

CDISC © 2010


Patient Care(EHR Systems)

NIH & Academia


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<>

Data Mapping

<> <> <>

Clinical Data Element: Angina


EMA)

CDISC © 2010


Patient Care(EHR Systems)

NIH & Academia


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Global Data Standards:(1) an agreed upon set of common data elements and

definitions; (2) consistency in how they are represented and “look” electronically

Standard Data Element: Angina


EMA)

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• Data Collection– Research Case Report Forms– EHR implementation

• Data Exchange– Clinical trial sponsor to FDA– EHR to EHR– EHR to outcomes registry or clinical trial

• Data Aggregation– Data Warehouses (e.g. US FDA)– Comparative Effectiveness Research

Why Standard Clinical Data Elements?

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US National Institutes of Health Grant

NIH ROADMAP FOR MEDICAL RESEARCHRE-ENGINEERING THE CLINICAL RESEARCH ENTERPRISE

Primary Aim: Improve interoperability by standardizing TB and Cardiovascular (CV) data elements

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Project Background

• 2006-2008: NIH grants awarded to Duke University; partnered with CDISC and HL7 to develop data standards for TB & Acute Coronary Syndrome (ACS)

• Leverage existing global standards and processes (CDISC, HL7) to ensure jointly approved standard

• TB project resulted in 139 standard DE’s with clinical definitions, SDTM mapping, data collection module

• ACS project resulted in 25 data elements with clinical definitions agreed to by American College of Cardiology, regulators and industry organizations

• Focus on and document development methodology

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ACS Data Element

Data Element Name: History of peripheral vascular disease

Clinical Definition: Indicate if the patient has a history of peripheral vascular disease. This can include:

1. Claudication either with exertion or at rest. 2. Amputation for arterial vascular insufficiency. 3. Aorto-iliac occlusive disease reconstruction, peripheral vascular bypass surgery, angioplasty or stent; or percutaneous intervention to the extremities. 4. Documented abdominal aortic aneurysm (AAA) repair or stent. 5. Positive non-invasive/invasive test.

This does not include procedures such as vein stripping, carotid disease, or procedures originating above the diaphragm.

Valid Values: Yes, No

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Data Collection Module

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TB Data Element

Data Element Name: Reason subject first came to medical attention

Clinical Definition: The reason the subject was first medically evaluated for possible TB disease or Latent TB infection

Note: clinical data elements are the “currency of exchange”

Valid Values: Symptoms, Contact Investigation, Source Case Investigation, Screening of High Risk Population, Unknown, Other (specify)

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Data Module with SDTM Annotation

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• Cavity• Fibrosis• Infiltrates• Mass calcified• Nodule not calcified• Volume loss• Volume collapse• Miliary Tuberculosis• Unable to determine

CDISC Controlled

Terminology

CDISC Controlled

Terminology

Sample TB Codelist: CXR Image Parenchymal Result

Standard Terminology Codelist

Codelist = Value Set = Permissible Values

CDISC © 2010

• Subject Matter Expertise• Definition writing and analysis• Terminology tagging and sub-setting • Terminology coding that ensures cross-

harmonization with key partner organizations • Terminology requests and maintenance • Links to other controlled terminologies as

needed (e.g. MedDRA, ISO etc.) • Supporting new disease areas beyond cancer

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NCI Terminology Services

http://www.cancer.gov/index.html

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CDISC Terminology Alignment

NCI Thesaurus

LOINC

SNOMED

MedDRA

MeSH

ICD’s...

76+Controlled

Vocabularies

NCI Metathesaurus

http://www.cancer.gov/index.html

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Resulting Development Methodology (cited in US FDA CDER Data Standards Plan)

1. Identify and prioritize Therapeutic Area for Standardization

2. Communicate and coordinate priorities3. Engage necessary stakeholders4. Identify core team leads and clinical experts for

working group5. Gather representative controlled vocabularies;

work with NCI EVS terminology experts6. Parse out unnecessary data elements; focus on

those that are clinically specific and relevant

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7. Develop and finalize draft set of data elements and clinical definitions

8. Align with CDISC standards and develop any new CDISC products

9. Release draft Therapeutic Area standard for global public review

10. Address public comments and release final Therapeutic Area standard

11. Load new standard into electronic environment for access, download and implementation

Resulting Development Methodology (cited in US FDA CDER Data Standards Plan)

CDISC © 2010

Protocol Form Setup & Config

Data Capture

Data Mgmt

Analysis Submissionand/orReporting

Review

CDASHProtocol SDTM (human), SEND (animal), ADaM

Controlled Terminology

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CDISC Clinical Data Flow

Disease Specific Standards

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TB Standards 2009-Present

• Industry biotechs and pharmas have implemented the TB standard in new trials (e.g. Otsuka)

• CDISC expert working with US CDC to map TB dataset to SDTM and TB standard

• US FDA pilot project to assess SDTM-TB mapping to help inform future submissions

• From CDC-FDA pilot, determine any extensions needed to SDTM and/or TB standard

• Bill & Melinda Gates Foundation, Global TB Alliance and CDISC to launch new TB projects

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• PKD Foundation 2009-2010– Polycystic Kidney Disease: standard clinical data elements,

definitions and terminology; public review July 2010

• Coalition Against Major Diseases (CAMD) and US NINDS 2009-2010– Alzheimer’s Disease– Parkinson’s Disease

• Other Evolving Projects– Oncology– Pediatrics– Imaging & Medical Devices– Extend Cardiology and TB standards

Other Disease Projects

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Strength through collaboration.If you are interested in contributing to CDISC Disease Projects or the Terminology Initiative, please contact me…

Bron W. KislerCDISC Senior [email protected]

cdisc japan interchange 20 july 2010 bron kisler · pdf filecdisc japan interchange. 20 july...

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