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Using caBIG Tools to Conduct Clinical Trials in Cooperative Groups

Using caBIG Tools to Conduct Clinical Trials in Cooperative Groups. Raymond Lord MD Principal Investigator Kalamazoo CCOP West Michigan Cancer Center Michele Ehlman, CTMS Analyst Center for Biomedical Informatics and Information Technology, NCI. caBIG Steering Committee April 2, 2009.

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Using caBIG Tools to Conduct Clinical Trials in Cooperative Groups

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  1. Using caBIG Tools to Conduct Clinical Trials in Cooperative Groups Raymond Lord MD Principal Investigator Kalamazoo CCOP West Michigan Cancer Center Michele Ehlman, CTMS Analyst Center for Biomedical Informatics and Information Technology, NCI caBIG Steering Committee April 2, 2009

  2. Survey of the Level of EMR Development in 2 Research Base Institutions Principal Investigators at ECOG November 2008 GOG January 2009

  3. 80 Institutions (ECOG 23 GOG 57) No one reported a totally paper medical record.

  4. Specific Electronic Items in EMRECOG and GOG = 80 Institutions Reporting

  5. Case Report Forms: Paper or Remote Data Capture? Paper Computer to Paper Patient’s Record Remote Data Capture Time consuming Risk for mistakes Personnel expense

  6. Researcher reads screen & writes in Data Lab Device Electronic Medical Record HL7 Data form Faxed or Mailed Research Base Statistical Center Data Record Reads Data Form and enters data Reports and Graphs Publications

  7. Researcher types Data to Research Web Site Lab Device Electronic Medical Record HL7 By this design the Research Base has avoided the manual entry on their part. Data is electronically sent Statistical Center Data Record Reports and Graphs Publications

  8. From One Computer to Another

  9. Researcher checks screen Lab Device Electronic Medical Record HL7 Data is sent electronically HL7 Research Base Statistical Center Data Record Reports and Graphs Publications

  10. Clinical Institutions X-Ray CT Patients Tumor Measurements EMR Laboratory CTCAE Clinical Trials Protocol eCRF Chemotherapy Radiation therapy Weight, Vital Signs Clinical Information Performance Status Case Report Forms Reviewed on Screen Research Base Statistical Center

  11. Can we bypass Manual Entry? eCRF eData Clinical Trials Conducted Manual Entry CRF Research Base

  12. Currently Identified Use Cases/Requirements • Ability to create a protocol electronically and replicate electronically at each site • Predefined Downloadable Treatment Plans to local computers for use electronically by clinicians • Ability for Lab values to be electronically linked to an EMR • Ability to upload and electronically link images to EMR • Ability to electronically link an executed consent form to EMR • Ability to electronically capture CTCAE for an EMR by the patient while waiting for their appointment. • Ability to send to eCRFs in packages to the Statistical Record Data Center

  13. Questions and Discussion

  14. Thank-you!

  15. Supporting Slides The following slides are for support and clarification.

  16. Use Case: Protocol Creation and Management Clinical Institutions Research Base Protocol Writing Program PSC eCRFs EMR download Clinical Trials Protocol Statistical Data Programs Tables, Graphs eCRF Patients Publications and Knowledge

  17. A Single Lab Value has a lot of Baggage Patient #’s time Name of Patient Date Source Lab Lab Value Units Lab Test Identifier Normal Range HL7/LOINC or CDE ID#

  18. Only the Lab Value shows up on the Clinician Worksheet Lab Exports EMR Clinician Worksheet time ID #’s Name Date Lab Value Source. 142 Lab Test Identifier Units Normals LOINC or CDE ID#

  19. Clinical Institutions X-Ray CT Patients Tumor Measurements Laboratory EMR CTCAE Clinical Trials Protocol Chemotherapy Radiation therapy Weight, Vital Signs Clinical Information Performance Status Case Report Forms Reviewed on Screen Research Base Statistical Center

  20. Use Case: Protocol Creation and Management Clinical Institutions Research Base Protocol Writing Program PSC eCRFs EMR download Clinical Trials Protocol Statistical Data Programs Tables, Graphs eCRF Patients Publications and Knowledge

  21. Use Case Sequence Research Base Protocol Writing Program eCRFs Patient Study Calendar (Schema/ Template) Harmonize Compatible Statistical Data Manipulation Programs Tables, Graphs

  22. Use Case Sequence Concept Research Base Protocol Writing Program eCRFs Patient Study Calendar (Schema/ Template) Statistical Data Manipulation Programs Tables, Graphs

  23. Use Case Sequence Research Base Protocol Writing Program eCRFs Patient Study Calendar (Schema/ Template) Written Protocol Consent eCRFs Schema/Template Statistical Data Manipulation Programs Tables, Graphs Clinical Trial Sites

  24. Clinical Institutions X-Ray CT Patients Tumor Measurements Laboratory EMR CTCAE Clinical Trials Protocol Chemotherapy Radiation therapy Weight, Vital Signs Clinical Information Performance Status Case Report Forms Reviewed on Screen Research Base Statistical Center

  25. Research Base Receivesthe eCRF Research Base Protocol Writing Program eCRFs Patient Study Calendar (Schema/ Template) The data is reviewed on screen and checked to see if any queries are needed. If no queries are needed the data is put into the Statistical Data Program Statistical Data Manipulation Programs Tables, Graphs Use Case Sequence

  26. FDA Research Base Chiefs Protocol Writing Tools eCRF Creators caBIG Tool Makers CTEP EMR Vendors Protocol Writing Program PSC eCRFs EMR download Clinical Trials Protocol Statistical Data Manipulation Programs Tables, Graphs eCRF Pharmaceuticals Statistical Data Manipulators All in the same room

  27. Electronic Case Report (form) -- eCRF Any pertinent data in EMR populates the eCRF E.g. Lab, Treatments, CTCAE, measurements Performance Status, Vital Signs Data is reviewable on Computer Screen Any missing data is retrieved and entered manually Data is sent in packages, for example a given cycle

  28. Various Electronic Medical Record Vendors represented during the Surveys ECOG November 2008 and GOG January 2009 Table 2 Others: Sorian Systems (1), Ulticase (1), McKesson (2), Siemens (1), IMPAC (1), General Electric (2), Fujuitsu (1), Phoenix (1), Sunrise (2), Meditech (1), Ahlta (1), eClinical (2), Centricity (2), Prime Clinical Management (1)

  29. Use Case Sequence Clinical Trial Sites X-Ray CT Patients Tumor Measurements EMR Laboratory CTCAE Clinical Trials Protocol Research Base Statistical Center

  30. CTCAEs can be filled out electronically while waiting for the doctor

  31. Clinical Institutions X-Ray CT Patients Tumor Measurements Laboratory EMR CTCAE Clinical Trials Protocol Chemotherapy Radiation therapy Weight, Vital Signs Clinical Information Performance Status Case Report Forms Reviewed on Screen Research Base Statistical Center

  32. eCRF is sent in Packages, for example, a Cycle Cycle #1 Performance Baseline Measurements Chemotherapy Send Day 1 8 15 21 Labs The data is not sent until it is complete, usually at the end of a cycle Use Case Sequence

  33. The Patient has now enrolled on a Protocol Protocol # time Subject # Date Source Lab Lab Value Units Lab Test Identifier Normal Range LOINC or HL7

  34. The Lab Identifier directs the population of the eCRF Lab Exports eCRF Protocol # time Subject # Date Lab Value Source. 142 Lab Identifier Units Normals LOINC

  35. Strings are carried along electronically ID #’s Name Date String Cycle Unique ID

  36. Strings are Created and Sent Clinical Institutions Patients Tumor Measurements EMR CTCAE Clinical Trials Protocol Chemotherapy Radiation therapy Performance Status Weight, Vital Signs Clinical Information eData Research Base Statistical Center

  37. Source Images of Measurements August 2005 October 2005

  38. Case Report Forms: Paper or Remote Data Capture? Paper Research Base requires Familiar; Transition time EMR can not populate Time consuming Tendency for mistakes Fatigue, Drudgery Personnel expense Mail, Fax Research Base re-enters Lose Code Remote Data Capture Research Base requires Familiar; Transition time EMR can not populate Time consuming Risk for mistakes Fatigue, Drudgery Personnel expense Immediate transmission Research Base does not re-enterLose Code Patient’s Record

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