A Peek at GCT 2012 - Eileen Daniels
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Transcript of A Peek at GCT 2012 - Eileen Daniels
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Data Quality Deconstructed:Do more, plan less
Global Clinical Trials14-Sep-2012 Boston
Eileen M. Daniel
Director, Clinical & Data Operations
©2012 Endo Pharmaceuticals, Inc. All rights reserved. 1
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 2
15+ years ago
New York CitySpring 1997
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 3
Today there is nothing new under the sun
… except maybe some clouds
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 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
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stating the obvious
©2012 Endo Pharmaceuticals, Inc. All rights reserved. 5
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 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.
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the plans (sigh)
© 2012 Endo Pharmaceuticals Inc. All rights reserved. 7
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 8
The plans for a global phase 3 study
– 3.5 FTEs with global responsibilitystudy leader | data manager | study specialist | clinical information mgr
– 450 subjects recruited from 120 sitesNorth America, Europe, India
– 10 service partners including 4 CROs
– All study data flows in electronically from three sourceseCRF, central laboratory, IVRS
– 1 protocol, 1 playbook and 7 global plans
Bladder cancer is challenging enough. Starting up was hard to do.
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 9
Alignment is possible so long as you manage the plans variables.
Starting up – forming our global study community
study community
study team
clinical sub team
clinical trial manager
study community >600+clinical investigators & team
study team >30+partner project managers
clinical sub-team >10trial managerresearch scientiststatisticiandata managerproject managementregulatory affairshealth economicspharmacovigilance …
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 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!
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forcing a slowdown at startup
11©2012 Endo Pharmaceuticals, Inc. All rights reserved.
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 12
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 13
Kick off meeting Study team preparation
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 14
Attention here please
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pre-prep preparation… JDI
15© 2012 Endo Pharmaceuticals Inc. All rights reserved.
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 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.
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 17
And They’re Off!
Final protocol to FPI: 12 weeks
ICFCRFDMPDRPSAPSafety PlanIDMC CharterMonitoring PlanEscalation PlanCommunication PlanClinical Supplies PlanFile Management PlanMedical Monitoring PlanSponsor Oversight PlanProject Management Plan
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ONCE OUT OF THE GATE, IT IS REALLY HARD TO
REIN THEM IN
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 19
– 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.
Hold up – deconstruct the protocol before inking any plans
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 20
+ The most overlooked: the plan to share it all with our sites.
Plans we find useful in a global, multi-regional study
– the protocol
– a 2-page Sponsor Oversight Plan 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 playbook that documents the plays for the tasks
completed by our service partners
– the global monitoring plan that describes expectations for on-site and centralized monitoring
tasks based on study risk analyses
– an integrated data management & review plan that describes the
what, when, how and who without replication of content that should be sourced elsewhere
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 21
site & study initiation
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 22
– 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.
New (?) approach to training
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©2012 Endo Pharmaceuticals Inc. All rights reserved. 23
Build a sense of community & keep it online
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final thought
NEAR-MANIACAL PERSISTENCEIS OFTEN NEEDED BUT
IT IS TOTALLY WORTH IT
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