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Ending a Clinical Trial with Clean Data:
It’s Achievable
Bypass Angioplasty Revascularization
Investigation 2 Diabetes (BARI 2D)
Sue Janiszewski
University of Pittsburgh
Society for Clinical Trials
May 18, 2010
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BARI 2D
The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial is sponsored by the National Heart, Lung and Blood Institute (NHLBI) and receives substantial funding from the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK).
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BARI 2D SponsorsBARI 2D received major funding from
GlaxoSmithKline
BARI 2D received significant funding from
Bristol-Myers Squibb Medical Imaging, Inc.
Astellas Pharma US, Inc.
Merck & Co., Inc
Abbott Laboratories, Inc.
Pfizer, Inc.
BARI 2D also received generous support from
Abbott Laboratories Ltd., MediSense Products
Bayer Diagnostics
Becton, Dickinson and Company
J. R. Carlson Laboratories, Inc.
Centocor, Inc.
Eli Lilly and Company
LipoScience, Inc.
Merck Sante
Novartis Pharmaceuticals Corporation
Novo Nordisk, Inc.3
BARI 2D Sites**University of Sao Paulo Heart Institute
**Toronto General Hospital/University Health Network
**Texas Health Science @ San Antonio/South Texas
*Mayo Clinic-Rochester
*Mexican Institute of Social Security
*University Hospitals of Cleveland/CASE Medical School
*Memphis VA Medical Center/University of Tennessee
*Montreal Heart Institute/Hotel-Dieu-CHUM
*Albert Einstein College of Medicine/Montefiore
*Fuqua Heart Center/Piedmont Hospital
*University of Alabama @ Birmingham
*Northwestern University Medical Center
*Na Homolce Hospital
*Ottawa Heart Institute/Ottawa Hospital-Riverside Campus
*New York Medical College/Westchester Medical Center
*Emory University
*Washington Hospital Center /Georgetown University
*Quebec Heart Institute/Laval Hospital
*University of British Columbia/Vancouver Hospital
NYU School of Medicine
Lahey Clinic Medical Center
University of Virginia
University of Minnesota
St Luke’s/Roosevelt Hospital Center
University of Florida
St Louis University
University of Texas @ Houston
Kaiser-Permanente Medical Center
Henry Ford Heart & Vascular Institute
Boston Medical Center
Fletcher Allen Health Care
Jim Moran Heart & Vascular Institute
Baylor College of Medicine
Duke University
University of Maryland Hospital
University of Chicago Medical Center
University of Pittsburgh Medical Center
Washington University/Barnes Jewish Hospital
Mount Sinai Medical Center
Mid America Heart Institute
University of Michigan
Johns Hopkins Bayview Medical Center
Brown University/Rhode Island Hospital
Houston VA Medical Center
New York Hospital Queens
Wilhelminen Hospital
St Joseph Mercy Hospital/Michigan Heart PC
Ohio State University Medical Center
Mayo Clinic-Scottsdale
** ≥ 100 participants * ≥ 50 and < 100 participants
North America - 1937 participants (USA:1499 participants, Canada: 353 participants, Mexico: 85 participants)
South America - 356 participants (Brazil: 356) Europe - 75 participants (Czech Republic: 65, Austria: 10)
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Core Laboratories (separate data collected at):AngiographicBiochemistry/GeneticsFibrinolysisECGNuclearEconomics
Management Centers (managed pt care, so timely data entry necessary):
Cardiovascular/HypertensionDiabetesLipidsLifestyle
BARI 2D
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Count2,368 Participants
49 Clinical Sites
6 Countries
6 Core Laboratories
4 Management Centers
1 Coordinating Center
36 forms, > 2,600 variables
How many data managers? 2 - 4 data managers6
BARI 2D Time Line
Jan 1 April 1 March 31 Jan 1 Nov 30
2001 2001 2005 2007 2008(Vanguard) (All sites)
Recruitment Recruitment Closeout Follow-up
Begins Complete Begins Ends
Average F/U 5.3 yrs
Steering Committees 2x/yr and then once after
recruitment ended7
Sources of Data
Visits Baseline (up to 16 forms)
Monthly visits first 6 months, then quarterly(1-5)
More extensive annual data collection (3 forms)
Events Revascularization-PCI/CABG (2 forms)
Stroke(2 forms)
Myocardial Infarction (2 forms)
Severe Hypoglycemia (1 form)
Death (2 forms)
Core Labs Angiograms
ECGs
Test results
Samples
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Who is Doing Data Entry?
Data collection by coordinator Data Entry by someone else
Perfect world
Reality
Coordinator collecting and tracking down data
for BARI 2D AND other projects
AND entering the data too
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BARI 2D Data Entry
Tools for data entry and cleaning used:
During the trial
As the trial approached the end
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BARI 2D Data Entry
Features include
• double entry for key forms
(enter and verify)
• edits for specific entry errors
• customized reports
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BARI 2D Data Entry
Tools for data entry and cleaning used:
During the trial
As the trial approached the end
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Data Cleaning Contributors • Coordinators - provide valuable insight
(ranges/possible edits)
• CC Administrators - brain storming strategies and
contacting site leadership
• Site leadership - make sure coordinator has
adequate time/support
• Data managers - responsible for dataset creation too,
during which errors were found
(e.g. Baseline)
• Analysts - find errors when using data in analyses
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BARI 2D Closeout
How long were patients followed? – Anywhere from 3-6 yrs of
follow-up
When to stop? – Chose anniversary of randomization starting
December 1, 2007 and ending November 30, 2008.
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Step by step strategyfor cleaning data
First get data entered
Then make sure the data is clean
Which data to emphasize first?
Events – can concentrate on one at a time
important as endpoints
Visits – after done with events
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Emphasize the positive
Group goals
Group accomplishments
Individual sites
recognized for meeting
goals
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Strategy 2 – Frequent contact w/data manager
By e-mail
By phone
Friendly neighborhood
data manager
By fax
(confirming
edit values)Very helpful to
set dates to talk
& work through
data issues
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Strategy 3 – Schedule pt. final visit early
Want to make sure last visit takes place because of the valuable information it yields.
If patient has to reschedule, you still have plenty of time before the end of the study.
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