ScienceTRAX

1. ScienceTRAX Clinical Research Informatics: Challenges And Trends John Putzke, Ph.D., M.S.P.H. ( john.putzke@sciencetrax.com ) ( putzke.john@Mayo.edu )

2. Research Process Common Tasks Dissemination Execution Planning Organize data Data analysis Coordinate write-up Generate output - Posters - Manuscripts - Presentations Integrate literature Create hypotheses Write protocols IRB interaction Create CRFs Enrollment Collect data Monitor study

3. Research Process Research Roles Dissemination Execution Planning Biostatisticians Investigators Administrative Staff Investigators Subjects Study Coordinator Technical Staff

4. Clinical Trial Management Systems Workspace Standardization and Infrastructure Subcommittee • Improve efficiency, reduce duplication of effort, and achieve cost savings • Facilitate innovation and promote integration across trials • Facilitate data interpretation and data comparison across trials • Allow for closer integration of biological measurements and clinical trial findings • Establish standards for the essential data to be collected in clinical trials and the format in which it is collected • Define core data elements • Define standardized Case Report Forms • Develop the caBIG standard infrastructure necessary to support clinical trials and interface caBIG with other databases utilizing standard elements

5. Research Process Research Roles Dissemination Execution Planning Biostatisticians Investigators Administrative Staff Investigators Subjects Study Coordinator Technical Staff Committee Focus

6. Research Process Research Roles Dissemination Execution Planning Biostatisticians Investigators Administrative Staff Investigators Subjects Study Coordinator Technical Staff What If?

7. Dissemination Focused Systems: Components Staying Current With Literature Planned Work • Library Tools • Queries • Prompts • Reference List Analytical Focus Notification Center Academic Output Investigator • Institutional • Reviewer • Submissions • Study • Staff & Subs • Opportunities • Collaborative Requests • Organize Tasks • Current Work • Templates Previous Work General • Reports • Archive • Leverage previous work Biosketch (administrative reports) Collaborator Exchange

8. StudyTRAX: Overall Map

9. Dissemination Focused Systems: Components Central Concern: Transformation of data into information, not data storage, drives design and functionality

10. Dissemination Focused Systems: Components Enable non-technical people Readily extract raw, recoded, and transformed data All system entities anticipate common analytic methods on a-priori basis Study Data Integrate data preparation methods and automate common analyses Manuscript (or report) Combine data across one or more studies Other Studies

11. How to do research better? Subjects Participation Study Coordinator Study execution Methodological Answer Pick Your Lens? Administrative Staff Oversight and security Technical Staff System integration & data standards Biostatisticians Transformation of data into information Investigators Applied Answer Traditionally left out

12. How to do research better? Academic Research: Investigator Endpoints Pick Your Lens? • Grant • Article • Presentation • Practice Improvement • Quality Reporting Direct impact on investigator time

13. StudyTRAX: Overall Map

14. StudyTRAX: Workbench Map

15. Taking the next step: Software Development Example software tool for clinical research

16. ScienceTRAX Clinical Research Informatics: Challenges And Trends John Putzke, Ph.D., M.S.P.H. (john.putzke@sciencetrax.com) (putzke.john@Mayo.edu)