Transcript Clinical Trials Xpress

Patricia A. Winger, President
Collaborative Clinical Research Solutions, Inc.
[email protected]
Copyright CCRS Consultants, Inc. 2016
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 CTX Staffing Update
 CRN Meeting & Wildly Important Goals
Today’s
Discussion
 Marketing Plan
 CTX Portfolio Update
Copyright CCRS Consultants, Inc. 2016
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Amber Froehlich
Program Mgr.
Team CTX
Debra Franco
Network Navigator
Ellie Meyer
Regulatory Specialist
Thien Ha
Business Analyst
Anna Menezes
Executive Coordinator
Stephanie Hulsey, RN
UT Health, Houston
Ann Sieber, MS, CIP (interim)
UT Southwestern Medical Center
Clinical
Research
Navigators
Ilona Nekhayeva, MD, PhD
UT Medical Branch, Galveston
Sandra Montez, RN
UT MD Anderson Cancer Center
Jason Bates and Gena Monroe
UT Health Science Center San Antonio
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The Four Disciplines
The Research
Navigator Book
Club
1. Focus on the Wildly Important Goals
(WIGS)
2. Act on the Lead Measures
3. Keep a Compelling Scoreboard
4. Create a Cadence of Accountability
Discipline One
The enemy of
execution?
Your day
job….aka “the
Whirlwind”
Goals are important – but
when urgency and
importance clash, urgency
wins every time.
When you narrow the focus
to one or two WIGs, the
team can easily distinguish
between what is top priority
and what is the whirlwind.
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Wildly
Important
Goals (WIGs)
Number of trials & subjects recruited
Time to study activation
Identify the most high-impact activities where
the CRNs can most influence WIG success.
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Discipline TWO
Some Actions
have more
Impact….
Act on the Lead
Measures
Lead measures are the most high-impact things
your team must do to reach the goal. Two
characteristics of lead measures:
1. They’re predictive of achieving the goal, and
2. The measure can be influenced by the team
Lag measures are the tracking measures of the WIG,
but the activity that drove them, is already in the
past (e.g., revenue, profit, customer satisfaction)
 In response to an RFP
Study Concept
Submissions to
TRCC Executive
Committee
 Direct from a
pharmaceutical company
Response to
RFP
Pharma
Unsolicited
 Unsolicited concepts
submitted by researchers
Clinical Trial
Concept
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CTX Lead
Measure
Activities to
Increase Study
Opportunities
(WIG #2)
 Proactive/Targeted Business Development
 Development of Key Messages,
Communication Channels and Marketing
Collateral by Target Audience
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 Institution-based Champions
 CTX Landing Page and Website
Marketing –
Business
Development
 FreshAIR Connections
 Shared CDA information with CTX – add to Velos
 Navigator Tool kit – elevator speech, CRC
Training and education opportunities, studyspecific patient recruitment tools
 Disease-Specific Protocol Development
(industry sponsored IITs)
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Pfizer SPIRE I and SPIRE II
CTX Early
Clinical Trial
Portfolio
 Phase 3 Evaluation of Bococizumab (PCSK9-inhibitor) in Reducing the
Occurrence of Major Cardiovascular Events in High Risk Subjects
TRCC Pilot Project RFP
 Each TRCC institution participating in a study will contribute $25,000
 At least 3 TRCC institutions for selected trial(s)
 PI to work with CTX team for study start-up activities
PARADOR: Midwest Area Research Consortium for Health
(MARCH)
 Prospective comparison of an ARNI with an ACE inhibitor on enDOthial
function by brachial artery Reactivity
SPIRE Dashboard
Principal
Investigators(s)
Salman Arain, MD
UT Health
Steven Bailey, MD
UTHSCSA
Parag Joshi, MD
UTSW
Sponsor - Pfizer
Phase III Randomized, Placebo-Controlled, Study Evaluating the Efficacy, Safety & Tolerability of
Bococizumab In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Subject Enrollment
Site
IRB Approved
UTSW
17,000 / 8,300
Avg. Daily Accrual
 42.4 subjects/day
SIV
ICON
Activated
Days Since
Activation
02/03/16
UTH
UTHSC-SA
Target/Current Accrual
01/12/16
02/12/16
02/11/16
30
02/16/16
Patients PreScreened
Patients
Enrolled
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2 scheduled
0
0
0
0
TRCC RFP for Pilot CTX Clinical Trials
Lead PI
Jon E. Tyson, MD, MPH UT Health
Title
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
Sponsor
Texas Regional CTSA Consortium RFP - Funding Amount $25,000 per CTSA site ($100,000)
Site
Status
Accrual
UTH
Enrolling
91
Stanford
Enrolling
24
Target Total Accrual
UTSW
Pending site initiation
-
Current Avg. Accrual Rate  3.25 patients/month
UTHSCSA
Pending site initiation
-
UTMB
Pending Intent to Rely
on IRB
-
11/16/15
Enrollment
03/01/16
03/01/16
210
03/18/16
03/24/16
PARADOR Dashboard
Principal
Investigators
Salman Arain, MD
UT Health
Joseph McCormick, MD
UT Brownsville
Title
Prospective comparison of an Angiotensin Receptor Neprilysin Inhibitor (ARNI) with an ACE inhibitor
on Endothelial Function by Brachial Artery Reactivity
Sponsor
Midwest Area Research Consortium for Health (MARCH), Univ. of Wisconsin at Madison - Novartis
Accrual Information
Category
Status
Feasibility
i2B2 searches conducted 12/2015
Contract
Revised and sent to MARCH 03/24
Budget
Pending UW IRB protocol approval
IRB Application MARCH submitted to UW IRB 03/10;
awaiting approval
Target Accrual
204
CTX Sites
N/A
Next Steps
UTH IRB Submission
BART Training - Brownsville
Study Drug Availability - June
Questions?
Copyright CCRS Consultants, Inc. 2016
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