Disease Specific Data Standards: Case Studies in TB and Cardiology

Transcription

1 CDISC 2010 Disease Specific Data Standards: Case Studies in TB and Cardiology CDISC Japan Interchange 20 July 2010 Bron Kisler CDISC 2010

2 Presentation Outline Why disease-specific standards? TB & Cardiology Projects Controlled Terminology New Disease Projects CDISC

3 Clinical Data Element: Angina Patient Care (EHR Systems) Regulators (FDA, PFDA, EMA) Industry (Pharma, CROs) NIH & Academia Comparative Effectiveness CDISC

4 Clinical Data Element: Angina Patient Care (EHR Systems) Regulators (FDA, PFDA, EMA) Industry (Pharma, CROs) Data Mapping <> <> <> <> NIH & Academia Comparative Effectiveness CDISC

5 Standard Data Element: Angina Patient Care (EHR Systems) Regulators (FDA, PFDA, EMA) Industry (Pharma, CROs) Global Data Standards: (1) an agreed upon set of common data elements and definitions; (2) consistency in how they are represented and look electronically NIH & Academia Comparative Effectiveness CDISC

6 Why Standard Clinical Data Elements? 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 CDISC

7 US National Institutes of Health Grant Primary Aim: Improve interoperability by standardizing TB and Cardiovascular (CV) data elements NIH ROADMAP FOR MEDICAL RESEARCH RE-ENGINEERING THE CLINICAL RESEARCH ENTERPRISE CDISC

8 Project Background : 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 CDISC

9 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 CDISC

10 Data Collection Module CDISC

11 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) CDISC

12 Data Module with SDTM Annotation CDISC

13 Sample TB Codelist: CXR Image Parenchymal Result Standard Terminology Codelist CDISC Controlled Terminology Cavity Fibrosis Infiltrates Mass calcified Nodule not calcified Volume loss Volume collapse Miliary Tuberculosis Unable to determine Codelist = Value Set = Permissible Values CDISC

14 NCI Terminology Services Subject Matter Expertise Definition writing and analysis Terminology tagging and sub-setting Terminology coding that ensures crossharmonization 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 CDISC

15 CDISC Terminology Alignment NCI Thesaurus LOINC SNOMED MedDRA MeSH ICD s Controlled Vocabularies NCI Metathesaurus CDISC

16 Resulting Development Methodology (cited in US FDA CDER Data Standards Plan) 1. Identify and prioritize Therapeutic Area for Standardization 2. Communicate and coordinate priorities 3. Engage necessary stakeholders 4. Identify core team leads and clinical experts for working group 5. Gather representative controlled vocabularies; work with NCI EVS terminology experts 6. Parse out unnecessary data elements; focus on those that are clinically specific and relevant CDISC

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

18 CDISC Clinical Data Flow Protocol Form Setup & Config Data Capture Data Mgmt Analysis Submission and/or Reporting Review Protocol CDASH SDTM (human), SEND (animal), ADaM Disease Specific Standards Controlled Terminology CDISC

19 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 CDISC

20 Biomedical Informatics without Borders CDISC

21 Other Disease Projects PKD Foundation Polycystic Kidney Disease: standard clinical data elements, definitions and terminology; public review July 2010 Coalition Against Major Diseases (CAMD) and US NINDS Alzheimer s Disease Parkinson s Disease Other Evolving Projects Oncology Pediatrics Imaging & Medical Devices Extend Cardiology and TB standards CDISC

22 Your Standards Experience CDISC

23 Strength through collaboration. If you are interested in contributing to CDISC Disease Projects or the Terminology Initiative, please contact me Bron W. Kisler CDISC Senior Director CDISC