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Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci

Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci. Michele Ehlman CBIIT contractor Essex Management caBIG ® CTMS / Population Science Joint Workspace Face-to-Face Meeting July 28 th 2010 – Madison, Wiscons in. Agenda.

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Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci

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  1. Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci Michele Ehlman CBIIT contractor Essex Management caBIG®CTMS / Population Science Joint Workspace Face-to-Face Meeting July 28th 2010 – Madison, Wisconsin

  2. Agenda • Translational Medicine Business Architecture Model (BAM) v2.0 • History • Current Status • Life Sciences • Clinical Research • Touch-points with other workspaces • POP-Sci – Touch-points • Review Pop-Sci Use cases • Future work

  3. History

  4. A Translational Medicine Business Architecture Model (BAM) "A blueprint of the enterprise that provides a common understanding of the organization and is used to align strategic objectives and tactical demands." Object Management Group, Business Architecture Working Group, Definition The Translational Medicine Business Architecture Model (BAM) is a blueprint of translational medicine. It documents a common understanding of the information, “what, who, how, where and when,” necessary to realize research, so that it is accessible to someone, who is not directly involved in research to align strategic objectives and meet tactical demands - providing a communications platform.

  5. Components of the Translational Medicine BAM Use Cases Scenarios A scientist is trying to identify a new genetic biomarker for HER2/neu negative stage I breast cancer patients. Using a caGRID-aware client, the scientist queries for HER2/neu negative tissue specimens of Stage I breast cancer patients Identify Specimens Workflow/Activity diagrams Common Vocabulary (EVS, caDSR & CRFs) Domain Analysis Models

  6. Researcher Biorepository Coordinator Use Case Model (BAM) Storyboards in use case s define the work flow and data flow that identify the pre- and post-conditions Activity Diagram Work Flow Data Flow Actors Static Elements Domain Models Class Diagrams Data elements exchanged in a data flow are fully specified in class diagrams Activities in activity diagrams could inform the work flow and functions of the applications Applications

  7. Work to date Total – 312 use cases developed • Life Sciences 79 use cases to date • Clinical Research 181 use cases + 37 Reports • Population Science - 13 Uses cases to extend Plan Study (continued work required to address Initiate, conduct and reporting) • Imaging workspace - 35 Use cases identified date to extend • Patients - 4 Use cases to extend to date

  8. Life Sciences • 70 use cases v1.0 • 9 additional v1.1

  9. Clinical Research – Plan Study • 48 use cases

  10. Clinical Research – Initiate Study • 21 Use Cases

  11. Clinical Research – Conduct Study • 87 use cases

  12. Clinical Research – Report and Analyze • 25 use case • 37 reports

  13. BAM Participants 3rd Millennium • Elaine Feund • Charlie Mead Baylor College of Medicine • Lauren Boyd • Pam Mayfield • David Steffen Booz Allen Hamilton • Anna Fernandez caBIG® Patient Advocate / Colorectal Cancer Coalition • Kate Murphy Cancer Research Center of Hawaii • Lynne Wilkens Cancer Therapy Evaluation Program (CTEP) • Shanda Finnigan • George Redmond • Donna Shriner • Steve Friedman Case Western • Bob Lanese CBIIT • Mary Agnes Templeton City of Hope • Joyce Niland • Susan Pannoni Columbia University • Ben May • Janie Weiss Consumer Advocates in Research and Related Activities • Diane Paul CTMS Task Force Member • Darlene Douglas-Post Dana Farber Cancer Institute Harvard • Kerry Higgins • Jane Brzozowski • Jomol Mathew Dartmouth • Paul Thompson Duke University • Bob Annechiarico • Vijaya Chadaram • Salvatore Mungal • Kim Johnson Essex Management • Gene Kraus

  14. BAM Participants (Slides 2) Gynecological Oncology Group (GOG) • Bill Elgie Marybird Perkins Cancer Center • Donna Bryant Mayo Clinic Cancer Center • Sharon Elcombe MD Anderson Cancer Center • Charles Martinez • Susie Bullock Memorial Sloan Kettering • Dawn Caron-Fabio NCI Cancer Imaging Program • Mia Levy NCI CBIIT • Dianne Reeves • Ann Setser • Brian McIndoe • Juli Klemm • John Speakman • Christo Andonyadis NCI Division of Cancer Prevention (DCP) • Troy Budd • Anne Tompkins • Beverly Meadows Northwestern University • Warren Kibbe Office of Communications (OCC) • Pat Winkler Oregon Health and Science University • Lara Fournier Patient Advocate • Virginia Hetrick • Greg Bielawski • Carolyn Petersen • Craig Lustig SAIC • John Freymann • Brenda Maeske Sanford Health • Holly Johnson Sapient • Stephen Goldstein • Michael Otjen • Malcolm James

  15. BAM Participants (Slides 3) ScenPro, Inc. (CBIIT Contractor) • Smita Hastak • Wendy Ver Hoef Semantic Bits • Paul Baumgartner St. Judes • Tad McKeon The Jackson Laboratory • Grace Stafford Theradex • Ronald LaCanna Thomas Jefferson University • Jack London UCLA • Buddy Dennis University of Texas - Austin • Scott Hunicke-Smith University California Irvine • Christine McLaren University of Alabama • John Sandefur University of Arkansas for Medical Sciences (UAMS) • Laura Hutchins • Dorothy Miles • Umit Topaloglu • Jeannette Lee University of California San Francisco (UCSF) • Sorena Nadaf University of Michigan • Julie Wietzke University of Nebraska Medical Center (UNMC) • Marsha Ketcham University of New Mexico • Robert Milius University of Wisconsin Madison • Rhoda Arzoomanian University Pittsburgh Medical Center • Uma Chandran Wake Forest University • Bob Morrell West Michigan Cancer Center • Raymond Lord

  16. Great Job!

  17. What Pop Sci Group has accomplished to date • Reviewed 8 Population Sciences Scenarios • Scenario 1: Comparing the Lozenge to the Patch for Smoking Cessation • Scenario 2: Families understanding Risks • Scenario 3: Survival Associates with Treatment vs. Observation • Scenario 4: Use Case for Mammography Screening Study • Scenario 5: Tailored Behavioral Intervention Study • Scenario 6: Cohort Study – Recruit Study Participants through the Army of Love / Health of Women Initiative • Scenario 7: Cross Sectional Survey • Scenario 8: Outcomes Study

  18. What Pop Sci Group has accomplished to date • Identified business specific goals (use cases) for each scenario • Mapped the use cases in the current clinical research and life science BAMs • Reviewed current use cases and extended as needed to include population sciences • Identified 13 additional use cases to expand current clinical research BAM

  19. Scenario 1: Comparing the Lozenge to the Patch for Smoking Cessation

  20. What Pop Sci Group has accomplished to date The Pop Sci BAM working group has • Has identified overlap in existing BAMs • Is laying the ground work for integrating the existing BAM work into an overarching Translational Medicine Model

  21. BAM Use Cases • The Biomedical Research Business Architecture Model is meant to represent the processes required for research. • They contain • Description • Storyboard • Actors • Pre-conditions • Basic Flow of events • Alternate Flows (as required) • Post-conditions • Alternate post-conditions • Notes (as required) • Definitions (as required) • They are meant to direct the functional requirements required for service development– not to define them.

  22. Develop Operational Plan

  23. Develop Intervention Plan

  24. Define Observational /Epidemiologic Plan

  25. Future of the BAM • Add use cases as they are identified by NCI/caBIG workspaces • Add the functional use cases and workflows required to allow service development.

  26. Use Cases – Business vs. Functional (the amount of information required to make them complete) Business Use Cases (Process) Functional Use Cases (Functions) Description of the goal and the functionality to accomplish the use case Storyboard Actors Primary and Secondary (including system interactions) Pre-conditions Work flow (including alternate flows, decision points failure conditions…) Post- conditions Notes • Description of the Key goal • Storyboard • Actors • Pre-conditions • Basic Flow of Events • Post- conditions • Notes (Meant to provide the basis for future service specific functional use cases )

  27. Workflows and Activity Diagrams Workflows • Serves as a visual representation of step-by-step activities and actions, in logical order, with support for choice, iteration and concurrency required to accomplish a specific goal (use case) • Provides basic knowledge so that the goal can be easily communicated and understood. Activity diagrams • A graphical representations of the over all process flow which is made up of multiple workflows Note: In the Unified Modeling Language, activity diagrams can be used to describe the business and operational step-by-step workflows of components in a system.

  28. Questions

  29. Carbone Cancer Center tour • Tour Departure Time: 6:45 PM CST • Shuttle Pick-up/Drop-off Location: Hotel Lobby • Tour Duration: 1 hour  (Tour duration may exceed 1 hour depending upon the number of questions raised by tour participants.)

  30. Thank-you Michele Ehlman michele.ehlman@nih.gov 860-235-8125 NCI caBIG® Knowledge Center Website https://cabig-kc.nci.nih.gov/MediaWiki/index.php/Main_Page CTMS Forum https://cabig-kc.nci.nih.gov/CTMS/forums/ Biomedical Research BAM page: https://cabig-kc.nci.nih.gov/CTMS/KC/index.php/Biomedical_Research_Business_Architecture_Modeling

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