A Peek at GCT 2012 - Eileen Daniels

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  • 1. Data Quality Deconstructed: Do more, plan less Global Clinical Trials 14-Sep-2012 Boston Eileen M. Daniel Director, Clinical & Data Operations ©2012 Endo Pharmaceuticals, Inc. All rights reserved. 1
  • 2. 15+ years ago New York City Spring 1997 ©2012 Endo Pharmaceuticals Inc. All rights reserved. 2
  • 3. Today there is nothing new under the sun … except maybe some clouds ©2012 Endo Pharmaceuticals Inc. All rights reserved. 3
  • 4. During this talk, I will – – – – – remind us of fundamentals provide facts about a global study tell you where & why we liberally apply brakes flashback to a deconstruction methodology close with thoughts on site and study initiation ©2012 Endo Pharmaceuticals Inc. All rights reserved. 4
  • 5. stating the obvious ©2012 Endo Pharmaceuticals, Inc. All rights reserved. 5
  • 6. We all know this The clinical trials we sponsor are research studies. – A study is conducted according to a well-defined study plan – That well-defined study plan is the protocol Clinical investigators are responsible for conducting studies in accordance with the protocol. We are obliged to oversee and keep sharp focus on: – Protection of human subjects – Integrity of study data – Compliance with applicable regulations To meet our oversight obligations we conspire to plan. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 6
  • 7. the plans (sigh) © 2012 Endo Pharmaceuticals Inc. All rights reserved. 7
  • 8. The plans for a global phase 3 study – 3.5 FTEs with global responsibility study leader | data manager | study specialist | clinical information mgr – 450 subjects recruited from 120 sites North America, Europe, India – 10 service partners including 4 CROs – All study data flows in electronically from three sources eCRF, central laboratory, IVRS – 1 protocol, 1 playbook and 7 global plans Bladder cancer is challenging enough. Starting up was hard to do. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 8
  • 9. Starting up – forming our global study community study community study community >600 +clinical investigators & team study team >30 study team clinical sub team clinical trial manager +partner project managers clinical sub-team >10 trial manager research scientist statistician data manager project management regulatory affairs health economics pharmacovigilance … Alignment is possible so long as you manage the plans variables. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 9
  • 10. Oh boy … the plans! I didn’t want to read any of them – Loads of variables – $75,000* total cost for one – Had to tease out – – – – the redundant the confounding the conflicting the work-inducing – 90%** is NOT REGULATED *I did not make this up **I made this up We needed a timeout! ©2012 Endo Pharmaceuticals Inc. All rights reserved. 10
  • 11. forcing a slowdown at startup ©2012 Endo Pharmaceuticals, Inc. All rights reserved. 11
  • 12. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 12
  • 13. Kick off meeting Study team preparation ©2012 Endo Pharmaceuticals Inc. All rights reserved. 13
  • 14. Attention here please ©2012 Endo Pharmaceuticals Inc. All rights reserved. 14
  • 15. pre-prep preparation… JDI © 2012 Endo Pharmaceuticals Inc. All rights reserved. 15
  • 16. The CI is not the only one waiting for a final protocol Sometimes it is a game to see who can hold out the longest. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 16
  • 17. And They’re Off! Final protocol to FPI: 12 weeks ICF CRF DMP DRP SAP Safety Plan IDMC Charter Monitoring Plan Escalation Plan Communication Plan Clinical Supplies Plan File Management Plan Medical Monitoring Plan Sponsor Oversight Plan Project Management Plan ©2012 Endo Pharmaceuticals Inc. All rights reserved. 17
  • 18. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 18
  • 19. Hold up – deconstruct the protocol before inking any plans – – – – – – – – Dissect for data Make an inventory Tie-back to protocol objectives Take out the WANTs, leave the NEEDs Dispense with the notion of a CRF page Identify a single point of origin for every item Draw a map to illustrate how it flows end to end Know how and where it will be presented in the study report – Accept this is an iterative process and it will be revisited. This is okay. Ask the questions no one else wants to, confront the risks early and often. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 19
  • 20. Plans we find useful in a global, multi-regional study protocol – the – a 2-page tells us at a glance where we have transferred obligations, the names of the people working our study and which organization’s SOPs are being followed – a PPT document with lots of white space called the completed by our service partners – the tasks based on study risk analyses – an what, when, how and who without replication of content that should be sourced elsewhere Sponsor Oversight Plan playbook that documents the plays for the tasks global monitoring plan that describes expectations for on-site and centralized monitoring integrated data management & review plan that describes the + The most overlooked: the plan to share it all with our sites. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 20
  • 21. site & study initiation ©2012 Endo Pharmaceuticals Inc. All rights reserved. 21
  • 22. New (?) approach to training – Study Initiation Meeting – No longer PI centric, no silo presentations – Advance enlistment of trusted sites – tell them they are coming along the way – start them up early & invest too much time – engage them in planning – Integrated delivery of study information – simulate screening a subject & processing through study – Service & technology providers are team members – Study team intends to learn as much as they teach First be armed with real-world qualitative experience, then go large. ©2012 Endo Pharmaceuticals Inc. All rights reserved. 22
  • 23. Build a sense of community & keep it online ©2012 Endo Pharmaceuticals Inc. All rights reserved. 23
  • 24. final thought