How We Managed a Multi-Year, Multi-Drug Clinical Trial
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Managing a clinical drug trial is an endeavor, filled with complex recording, scheduling and reporting requirements. The effort becomes more convoluted when the trial involves multiple drugs from multiple manufacturers. Though tools and methodologies are readily available for single drug trials, approaches to multi-drug trials are generally a cobbling together of tools and methodologies that may not be optimal. Fortunately, Jira is an ideal tool for managing more complex clinical trials. We'll show how Jira was tailored to track the full path of a multi-year, multi-drug clinical trial. Leveraging Jira workflows and automation, a solution was crafted to track all stages of the trial, handle issue and schedule creation based on required protocols, and provide traceability.
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How We Managed a Multi-Year, Multi-Drug Clinical Trial
- 1. Managing a Dual Drug Clinical Trial with Jira JESSI SMITH | SENIOR CRC | DIAN-TU MICHAEL MARCH | SR ATLASSIAN DUDE | ISOS TECHNOLOGY | @COWMIX
- 2. Study Backgrounder Intro Collaborate Oversight DIAN-TU Introduction • Launched in 2012 • World’s first prevention trial for at-risk families with Dominantly Inherited Alzheimer’s Disease (DIAD) • Focus on interventional therapies that can change the course of Alzheimer’s Disease
- 3. Study Backgrounder Intro Collaborate Oversight A Collaborative and Unique Effort • Worldwide collaboration of research institutions and pharmaceutical companies • Patients and families contributed input into trial design • Adaptive platform trial with more than one therapy
- 4. Study Backgrounder Intro Collaborate Oversight Sponsor Oversight • Protecting confidentiality • Effective collaboration • Good Clinical Practice = Good Sponsor Oversight
- 5. This problem did not scream “Jira!” What were the alternatives?
- 6. • Doesn’t fully meet the need • Difficult to customize • Too expensive Use established clinical trial software systems (CTMS) SOLUTION 1 RULED OUT
- 7. • No audit trail • Too difficult to be proactive • No workflow • Hard to do concurrent access Use spreadsheets SOLUTION 2 RULED OUT
- 8. .. and we tried using spreadsheets..
- 9. .. and this is only part of one tab.
- 10. • Huge upfront cost • Expensive maintenance costs over time Custom Software SOLUTION 3 RULED OUT
- 11. This problem now screams “Jira!”
- 12. Solution Found Complex Model Goals Complex Management Problem • Need to coordinate 100’s of people and events around the world • Need visibility on past, current and upcoming events • Need processes / workflow to deal with exceptions
- 13. Solution Found Complex Model Goals Inspiration for Implementation • Atlassian’s Dan Radigan’s “Jira for Asset Management” was published in March 2014. • Jira issues represented assets in a organization (computers, printers, etc) • The workflow for that Jira issue represented the life-cycle of that asset • Links between Jira issues associate assets with locations, people, etc
- 14. Solution Found Complex Collaborate Goals Implementation Goals • Leverage Jira and Jira Concepts • Minimal customizations (addons) • Use Jira to manage participant side of trial • Use Jira to help manage the administration of the trial
- 18. Onboarding Universal Setup Study Path All participants go through these exact steps.
- 19. Onboarding Universal Setup Study Path Study suitability , screening and patient information is collected in this process.
- 21. Onboarding Universal Setup Study Path Drug arm is selected and participant starts study.
- 23. Walk Through One Drug Arm
- 24. Drug Arm Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4
- 25. Drug Arm Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4 “magic” first dose date….
- 26. Drug Arm Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4 Drives all event creation…
- 27. Drug Arm Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4 Drives all event creation…
- 28. Drug Arm G Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4 Drives all event creation…
- 29. Drug Arm G Workflow G SCAN READY G A 7 PREP G GROUP G AMENDMENT 4 More events…
- 30. Drug Arm G Workflow G A 7 PREP G AMENDMENT 4 Link Imaging Site G SCAN READY G GROUP
- 31. Drug Arm G Workflow G A 7 PREP G AMENDMENT 4 Each Imaging Site is a Jira Issue G SCAN READY G GROUP
- 32. Drug Arm G Workflow G A 7 PREP G AMENDMENT 4 Validation will allow for Scan Site linking. G SCAN READY G GROUP
- 36. Drug Arm G Workflow G A 7 PREP Starting Amendment (phase) 4 G GROUP G AMENDMENT 4 G SCAN READY
- 37. Drug Arm G Workflow G A 7 PREP Linked Events Increase (over 2 years) G GROUP G AMENDMENT 4 G SCAN READY
- 38. Drug Arm G Workflow G A 7 PREP Starting Amendment (phase) 4 G GROUP G AMENDMENT 4 G SCAN READY
- 39. Drug Arm G Workflow G A 7 PREP Linked Events Increase (over 4 years) G GROUP G AMENDMENT 4 G SCAN READY
- 40. The next few amendments are more of the same.
- 41. Drug Arm G Workflow G GROUP G SCAN READY G A 7 PREP G AMENDMENT 4 G AMENDMENT 7 PREP • Creates more events (like other amendments) • Workflow transition also removes events to correct protocol for the rest of the trial • (Amendment 5 does similar add / delete actions too)
- 43. Get Your Info Dashboards JQL Summary All Standard Jira Stuff!
- 44. Get Your Info Dashboards JQL Summary All Events for Participant Project = PE and “Subject Number Event” = [participant id] ( and IssueType = “Cognitive Testing )
- 45. Get Your Info Dashboards JQL Summary Trends in Cognitive Testing Administration project = "Participant Events" AND issuetype = "Cognitive Testing" AND "Cognitive Visit Issue Notes" is not EMPTY ORDER BY "Cognitive Testing Rater" DESC
- 48. Wrap-up
- 49. Wrapping up Add-ons Stats Take Aways Add-ons App • For Participant Tracker • Jira Suite Utilities • Started with: ScriptRunner Migrated to: JMWE • Other • Tempo Timesheets • Jira Software • THAT’S IT!
- 50. Study Backgrounder Important Statistics • Exactly four years of using the tracker • ~250 participants tracked • ~20,000 events tracker • 1000s of issues that are not directly tracking participants Add-ons Stats Take Aways
- 51. Study Backgrounder Add-ons Stats Takeaways Takeaways • No substantial regrets on technical implementation • Proved to be very adaptable and dynamic to respond to amendments • Fulfilled goals of: • Accountability • Scalable (people/process) • Dynamic Change • Proactive monitoring
- 52. Thank you! JESSI SMITH | SENIOR CRC | DIAN-TU | @JESSISMITH1024 MICHAEL MARCH | SR ATLASSIAN DUDE | ISOS TECHNOLOGY | @COWMIX