a peek at gct 2012 - eileen daniels

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

©2012 Endo Pharmaceuticals Inc. All rights reserved. 2

15+ years ago

New York CitySpring 1997


Today there is nothing new under the sun

… except maybe some clouds


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

stating the obvious

©2012 Endo Pharmaceuticals, Inc. All rights reserved. 5


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.

the plans (sigh)

© 2012 Endo Pharmaceuticals Inc. All rights reserved. 7


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.


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 …


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!

forcing a slowdown at startup

11©2012 Endo Pharmaceuticals, Inc. All rights reserved.


Kick off meeting Study team preparation


Attention here please

pre-prep preparation… JDI

15© 2012 Endo Pharmaceuticals Inc. All rights reserved.


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.


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


ONCE OUT OF THE GATE, IT IS REALLY HARD TO

REIN THEM IN


– 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


+ 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


site & study initiation


– 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


Build a sense of community & keep it online

final thought

NEAR-MANIACAL PERSISTENCEIS OFTEN NEEDED BUT

IT IS TOTALLY WORTH IT

a peek at gct 2012 - eileen daniels

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