Transcript Quintiles Site Management - University of South Florida

Quintiles Site Management
Kim Davis, SSRM
June 17, 2014
Copyright © 2013 Quintiles
Quintiles Mission:
Quintiles helps to improve healthcare worldwide by providing a broad
range of professional services, information and partnering solutions to
the pharmaceutical, biotechnology and healthcare industries.
Our Passion:
Improving patient treatment options by helping our customers deliver
new medicines
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QUINTILES FACTS
 Founded in 1982
 25,000 professionals in 62 countries
 Range of services from Drug development to commercialization
 Of the top best-selling drugs Quintiles has helped develop or
commercialize everyone.
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Clinical Trial Challenges
 Experienced research sites are saturated with opportunities
 50% of sites enroll 90% of the patients in any given trial
 30% of sites selected and initiated NEVER enroll 1 single patient
 80% of Clinical Trials fail to meet initial enrollment quotas creating
potential losses between $600,000 to $8M Daily*
* Source: Cutting Edge Information, “Web-Based Patient Recruitment”
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Clinical Trial Challenges
Site Challenges Include:
• Competition for studies
• Lack of focus on enrollment
• Challenges with particular
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patient population
Competition for patients to participate in
studies
Lack of adequate staffing
Limited knowledge or training
Complex drug/device protocol
Data collection challenges
Protocol errors
Patient retention
Partnership Goals
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Study Opportunities
Patient enrollment focus
Facilitate site selection
Site motivation / focus
Resolution of site issues
Site communication
Patient retention
Improved site quality
Regular performance review
• Study Timelines
• Decrease Overall Cost
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Quintiles Partner Program
– A worldwide network of top Investigative sites who conduct their studies to the
highest quality standards who have a
strategic alliances and acquisitions in order to enhance timely enrolment of
patients on global studies:
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Program initiated in 2004
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Over 1500 worldwide Partner Investigators
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Relationships Matter
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Proven improved site performance
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Improved investigator satisfaction
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Program Goals
> Explore avenues to expand the current investigative site pool
> Develop creative patient recruitment strategies
> Identify high performing investigative sites using qualitative and
quantitative data – eliminate non-performing sites
> Improve relationships with quality sites and gain greater efficiencies
from start up to close out.
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Site Continuum
From Tactical to Strategic to Transformative
Prime Sites
Partner Sites
Standard Sites
Relationship re-invented
with every study; little
consistency or value for
either party
Tactical
(<1 studies/yr)
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Relationship
actively
managed;
Relationship
actively
exploration
of process of
managed;
exploration
alignmentalignment
for efficiency;
process
for
pipeline comparison to site
efficiency; pipeline
capabilities for planning of
comparison
to site
future
study placement
capabilities for planning of
future study placement
Strategic
(1-8 studies/yr)
Mutual commitment at senior
levels to collaborate on all
appropriate studies;
operational/functional
alignment; long-term planning
and goal-setting; dedicated
alliance manager assigned;
joint corporate governance of
relationship
Transformative
(8-20+ studies/yr)
Therapeutic Alliances
Long term strategy - developmental not prescriptive
Class based on results not ambitions
Support against milestones
Mutual collaboration and aligned goals allows a new type of relationship
- Focused patient population
- High level of oversight
- Volume based on current study mix
Transformative - Beyond the Traditional Site Relationship
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Benefits of Partner Site Status
Why do Good Sites Participate?
Quintiles High Study Volume
 Increased number of trials
 Increased access for patients to new medications
 Differentiation from other physician practices
Quintiles Operational Expertise
 Advice and tools to improve site’s recruitment
 Sharing best practices to streamline processes at the site
 Sharing of metrics to compare performance to others
Quintiles Commitment
 Work together on feasibility of relevant protocols
 Insight into industry pipeline for key indications
 Relationship manager to provide high quality customer
service around the clock
 An advocate for the site within Quintiles
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Right Sites
Globally Partner Site recruitment rates are, on average, 50% higher
Partner Site Outperformance
Enrollment Rate
22%
86%
Emerging Mkts
USA/Canada
Avg Partner Enr Rate
50%
52%
Western Europe
Global
Avg Non Partner Enr Rate
*Analysis included standard trials with enrollment closed between 2009-2011 and a minimum level of partner site participation.
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Partner Site Expectations
What does success look like?
Streamline Site Identification process
Faster Study Start Up
Best in Class Recruitment
Improved Overall Trial
Performance
QUALITY
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Current Pipeline
Pipeline by Therapeutic Area - USA
Cardiovascular
5%
Allergy/Immunology
1%
Dermatology
3%
Rheumatology
12%
Endocrinology
9%
Respiratory
10%
Gastrointestinal
5%
Other
12%
Orthopedics
3%
Ophthalmology
1%
Hematology/Oncology/
Transplantation
19%
Neurology
10%
Infectious
Disease
9%
Nephrology
1%
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Opportunities Won
Primary Indication
Therapeutic Indication
Phase
Other
Not applicable
Phase 1
Allergy/Immunology
Respiratory
Hematology/Oncology/Transplantation
Hematology/Oncology/Transplantation
Neurology
Hematology/Oncology/Transplantation
Endocrinology
Endocrinology
Endocrinology
Gastrointestinal
Endocrinology
Cardiovascular
Infectious Disease
Hematology/Oncology/Transplantation
Rheumatology
Allergy
COPD
Non-small cell lung cancer
Solid tumor configuration
Multiple sclerosis
Chronic lymphocytic leukemia
Diabetes mellitus type 2
Diabetes mellitus type 2
Diabetes mellitus type 2
Ulcerative colitis
Acromegaly
Cardiovascular Disease
RSV
Sickle cell disease
Rheumatoid arthritis
Phase 3b
Phase 2
Phase 2
Phase 1
N/A
Phase 3b
Phase 3b
Phase 3b
Phase 3b
Phase 2
Phase 3
Phase 2
Phase 1
Phase 1
Phase 1
Neurology
Epilepsy
Phase 1
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First Patient Entered
Population Age Group
Date
5/22/2014
Adult – 17+ Years
Adolescents – 12 Years to 16 Years; Adult –
5/29/2014
17+ Years
7/1/2014
Adult – 17+ Years
7/1/2014
Adult – 17+ Years
7/1/2014
Adult – 17+ Years
7/1/2014
Adult – 17+ Years
8/1/2014
Adult – 17+ Years
9/1/2014
Adult – 17+ Years
9/1/2014
Adult – 17+ Years
9/1/2014
Adult – 17+ Years
9/30/2014
Adult – 17+ Years
12/1/2014
Adult – 17+ Years
12/31/2014
Adult – 17+ Years
1/12/2015
Adult – 17+ Years; Geriatrics – 75+ Years
3/27/2015
Adult – 17+ Years
6/30/2015
Adult – 17+ Years
Children – 2 Years to 12 Years; Adolescents –
11/1/2016
12 Years to 16 Years
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Monthly Site Review
Enrollment
Protocol
Primary
Current Study Site
Number
Sponsor Name Indication
Status
WA21092
Hoffmann-La Roche
Multiple sclerosis Enrollment Closed
H8A-MC-LZAX Eli Lilly and Company
Alzheimer's diseaseEnrollment Open
BAN2401-G000-201
Eisai Limited
Alzheimer's diseaseEnrollment Open
S187.3.005
Solvay Pharmaceuticals
Parkinson's diseaseEnrollment Closed
101MS326
Biogen Idec
Multiple sclerosis Enrollment Closed
I1F-MC-RHAP Eli Lilly and Company
Arthritis
Enrollment Open
H8A-MC-LZAO Eli Lilly and Company
Alzheimer's diseaseEnrollment Closed
MK-8237-001 Merck Sharp & Dohme
AllergicCorp.
rhinitis
Enrollment Open
WA21093
Hoffmann-La Roche
Multiple sclerosis Enrollment Closed
ACP-103-015 ACADIA Pharmaceuticals
Parkinson's diseaseEnrollment Closed
NV20234
Hoffmann-La Roche
Influenza
Enrollment Open
D1050325
Sunovion Pharmaceuticals
Schizophrenia
Enrollment Open
NV20234_ext Hoffmann-La Roche
Influenza
Enrollment Open
No. of Days
Open for
SUBJECT
SUBJECT
Investiga Investiga
Enrollment
S
SUBJECT
SUBJECTS
SUBJECTS
S
MED_EN
tor First tor Last
Site Startup (x = No. of SCREENE SCREEN SUBJECTS ENROLLMEN RANDOMIZ DISCONTI RL_FACT
Account Name
Name
Name
Date
Days)
D
FAILURES ENROLLED T FAILURE
ED
NUED OR
University of South Florida
Derrick
Robertson
2-Nov-11 500 < x
16
6
10
0
10
3
360%
University of South Florida
Balebail
Physicians
Raj Group
9-Aug-13 300 < x ≤ 500
3
0
3
0
3
0
100%
USF Suncoast Gerontology
Amanda
Center
Smith
7-Mar-13 300 < x ≤ 500
6
3
3
0
3
0
111%
University Of South Florida
RobertMedical
Hauser
Center
8-Apr-10 500 < x
3
0
3
0
3
2
74%
University of South Florida
Derrick
Robertson
27-Feb-12 500 < x
2
1
1
0
1
0
75%
University of South Florida
John
Carter
26-Nov-13 200 < x ≤ 300
0
0
0
0
0
0
0%
USF Health Byrd Institute
Balebail Raj
15-Jun-11 500 < x
4
0
4
0
4
1
70%
University of South Florida
DennisAsthma,
Ledford
Allergy & Immunology
27-Jun-13 300 < x ≤ 500
2
0
1
1
0
0
20%
University of South Florida
Derrick
Robertson
9-Jul-11 500 < x
2
0
2
0
2
1
43%
USF Health Byrd Institute
Robert
Hauser
22-May-09 500 < x
3
0
3
0
3
1
100%
University of South Florida
Michael
- All Children's
Nieder Hospital
16-Feb-10 500 < x
0
0
0
0
0
0
0%
University of South Florida
Tanya
Murphy
18-Feb-14 100 < x ≤ 200
0
0
0
0
0
0
0%
University of South Florida
Sally
Alrabaa
23-Oct-13 200 < x ≤ 300
0
0
0
0
0
0
0%
Zero Enrollers – If site does not enroll a patient within 100 days of site initiation
Greater Than 100 Days
Protocol
Primary
Number
Sponsor Name Indication
I1F-MC-RHAP Eli Lilly and Company
Arthritis
D1050325
Sunovion Pharmaceuticals
Schizophrenia
Current Study
Site Status
Enrollment Open
Enrollment Open
Account
Name
USF
USF
SITE_INITIA
TION_VISIT
_LATEST_D
ATE_BEFOR
Investiga Investiga
E_FIRST_SU
tor First tor Last SITE
BJECT_SCRE
Name
Name
INITIATED ENED
John
Carter
26-Nov-13 26-Nov-13
Tanya
Murphy
18-Feb-14 18-Feb-14
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No. of
Days
Open for
Enrollme
nt (x =
SUBJECT
No. of
SUBJECTS SCREEN
Days)
SCREENED FAILURES
200 < x ≤ 300 0
0
100 < x ≤ 200 0
0
SUBJECTS SUBJECT SUBJECT
ENROLLME
S
S
MED_EN
SUBJECTS
NT
RANDOM DISCONTI RL_FACT
ENROLLED FAILURE
IZED
NUED
OR
0
0
0
0
0%
0
0
0
0
0%
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Monthly Site Review
Zero Enrollers
Less Than 100 Days – new studies awarded in last 100 days
Primary
Protocol Sponsor
Indicatio
Account
Number Name
Phase
n
Current Study Site Status Name
OMS824-HTD-002
Omeros Phase 2 Alzheimer'sEssential
disease Documents in placeUSF
ECU-MG-301
Alexion Pharmaceuticals
Phase 3 Disorder ofEnrollment
nervous system
Open
USF
D1050325 Sunovion Pharmaceuticals
Phase 3 Schizophrenia
Enrollment Open
USF
Investiga
tor First
Name
Juan
Tuan
Daniel
Investiga
tor Last
Name
SITE INITIATED
Sanchez-Ramos31-Mar-14
Vu
28-Mar-14
Fallon
21-Mar-14
No. of Days
Open for
Enrollment (x =
No. of Days)
70 < x ≤ 100
70 < x ≤ 100
70 < x ≤ 100
SUBJECTS
SCREENED
0
0
1
SUBJECT
SCREEN
FAILURES
0
0
1
SUBJECTS
ENROLLED
0
0
0
SUBJECT
S
SUBJECT SUBJECT
ENROLL
S
S
MED_EN
MENT RANDOM DISCONTI Enrollme RL_FACT
FAILURE
IZED
NUED
nt Rate
OR
0
0
0
0
0
0
0
0%
0
0
0
0
0%
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Study Quality
Protocol Deviations are tracked and reviewed
Sponsor Name
Protocol Number
Solvay Pharmaceuticals
S187.3.001
Solvay Pharmaceuticals
S187.3.005
AstraZeneca
D0490C00005
AstraZeneca
D144AC00001
AstraZeneca Research and Development
D4300C00002
AstraZeneca Research and Development
D4300C00003
AstraZeneca Research and Development
D4300C00005
MedImmune
MI-CP147
Biogen Idec
101MS326
Biogen Idec
223AS302
Biogen Idec
997HA301
Not Available
223AS304
Dainippon Sumitomo Pharma America,
D1050236
Inc.
Dainippon Sumitomo Pharma America,
D1050256
Inc.
Sunovion Pharmaceuticals
D1050235
Right
Investiga Investiga Right
Patients
tor Last tor First Patients Consente
Account Name
Name
Name
Recruited d
University Of South Florida Medical Center Hauser Robert
University Of South Florida Medical Center Hauser Robert
100.00% 100.00%
University of South Florida
Hauser Robert
100.00% 100.00%
University Of South Florida IRB
Bengtson Michael
100.00% 100.00%
University Of South Florida IRB
Carter
John
100.00% 100.00%
University Of South Florida IRB
Carter
John
100.00% 100.00%
University Of South Florida IRB
Carter
John
100.00%
0.00%
University of South Florida, College of Medicine
Lujan-Zilbermann
Jorge
100.00%
University of South Florida
Robertson Derrick
100.00% 100.00%
University of South Florida
Vu
Tuan
60.00% 100.00%
University Of South Florida Medical Center Saba
Hussain
University of South Florida
Vu
Tuan
100.00% 87.50%
University of South Florida
Hidalgo Rosario
100.00% 84.00%
University of South Florida
Hidalgo Rosario
100.00% 71.40%
University of South Florida
Hidalgo Rosario
100.00% 86.70%
Patients
without
IP
Deviation
s
Patient
Data
Correctly
Captured
Patient
SAEs
Correctly
Reported
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
0.00% 100.00%
100.00% 100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
50.00%
100.00%
100.00%
100.00%
Average
GCP and
Protocol
Complian
ce %
100.00%
100.00%
90.00%
100.00%
100.00%
80.00%
100.00%
100.00% 85.70%
100.00% 92.60%
100.00% 100.00% 100.00%
83.30% 84.00% 100.00%
50.00% 92.90% 100.00%
100.00% 93.30% 100.00%
97.50%
88.40%
82.90%
92.90%
Patients
Complete
on
No. of
No. of
Complete Patients Patients
d Studies Screened Enrolled
0
0
3
3
8
6
75.00%
4
4
0.00%
1
1
100.00%
1
1
1
1
1
0
2
1
60.00%
24
20
0
0
87.50%
8
8
91.70%
25
12
14
14
15
4
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New Study Opportunity Process
• Opportunities
> Pre-Award bid defense
> Feasibility – if Quintiles were awarded this study would you be interesed
> Post Award – Relationship Mgr places the best sites on a list
• Next Steps
> CDA – USF has a Master CDA however some Sponsors do not accept
- Turnaround time on this is very important
> Right PI – how does OCR know what PI’s want which studies?
> eSIF – to be completed by the PI or Site Director or Study Coordinator
- Turnaround time on this is very important
> Site Selection is made by review of MANY parameters and data
- Performance metrics are very important as the Sponsor & Quintiles select the
best sites
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How to be a successful Partner Site
> New Study Opportunities
- Pipeline
- New Opportunities communicated to Master Contact
- Quick turnaround on PI interest, CDA Signature &
completion of eSIF
> Site/PI Identification
- Right Site, Right PI, Right Patient Population
- Start up – efficiency important
- PI Capabilities very important
> Measure engagement / commitment
- PI interest / capabilities assessment
- Timely response
- Timely start up process
> Key
- Centralized Functions
» Budgets | Contracts | IRB | Regulatory
- Training & Staff Education
- Core Processes & Procedures
- Communication/Relationship with each division/PI
conducting research
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Questions
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