1. Image Reading Center, Inc.
“Advances in ClinicalTrial Imaging”
Mark Punyanitya
Founder, President, CEO
2013-07-01
1
2. INTRODUCTION
An
Imaging
CRO
for
Academic,
Pharma/Biotech,
or
Medical
Device
Companies
who
need
to
develop
and/or
implement
Advanced
Imaging
Biomarkers
We
provide
a
soluBon
that
is
tailored
to
each
client’s
specific
need
or
situaBon,
and
not
driven
by
pre-‐exisBng
business
processes.
² Global
MulB-‐Center
Trials
² POC,
Phase
I,
II,
III
Studies
² Government
–
NIH,
NIA,
,
NIDDK,
NCIRE
² Industrial
–
PharmaceuBcal
and
Biotech
² Pilot
Academic
–
CUMC,
JHU,
UAB,
UCLA,
UCSF
4. IMAGE READING CENTER, INC.
4
CLINICAL
TRIAL
EXPERIENCE:
Therapeu3c
Area
Trials
Phase
Countries
Sites
Subjects
Images
MyostaBn
3
I
3
5
300
900
Growth
Hormone
3
II
25
50
350
1750
Osteoporosis
5
II
US
Only
15
800
6400
HIV/AIDS
1
III
7
7
350
1050
Diabetes
4
III
10
35
750
3000
Lipodystrophy
3
III
25
25
850
2550
Obesity
4
III
US
Only
50
800
2400
HIV/AIDS
2
NIH
US
Only
18
5000
15000
Experience
with
over
10,000
paBents
5. BENEFITS OF USING IRC
IRC has the expertise to manage trials with multiple imaging sites ensuring
consistency, standardization, and quality across all sites. We offer the following
benefits:
¡ Single Point of Contact
¡ Preparation of key regulatory documents
¡ Standardization of image acquisition at sites
¡ Training of key site personnel on protocol and image acquisition
¡ High level of image data quality and scientific validity
¡ Consistency and reliability in the analysis process
¡ Access to high quality physician readers
Our goal is to ensure accuracy and precision throughout the trial
lifespan.
6. CLINICAL TRIAL SERVICES
6
¡ Protocol Development and Pre-Study Planning
¡ Image Acquisition Manual, Independent Review Charter,
and Study Forms Development
¡ Reader Selection and Preparation
¡ Clinical Site/Imaging Facility Initiation and Training
¡ Image Data Collection and Verification
¡ QA/QC Processes
¡ Data Processing
¡ Expert Physician Review Review
¡ Regulatory Submission
7. SITE DOCUMENTATION
7
Independent Review Manual: Reader Procedures
u Read Process
u Computer Systems
u Reference Tools
Study Procedure Manual: Site Procedures
u Image Acquisition per Protocol
u Study Form Completion
u Submission of Imaging Data to IRC
Imaging Review Charter: IRC Procedures
u Imaging Data Acquisition, Site Training, Roles
Responsibilities, Data Handling, Data Transfer, etc.
8. • Sort-term and long-term
longitudinal instrument
quality control
• Cross calibration of DXA
equipment for BMD/
Body Comp with VCP
phantom
• Oversight of equipment
upgrades
INSTRUMENT QUALITY CONTROL
9. BACKGROUND
9
• Imaging allows for earlier detection of change/effect
• Enhanced ability to make critical “go/no-go” decisions
• Regulatory agencies are increasingly accepting imaging
1Cutting Edge Information (Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design)
Recruit
Subjects
Administer
Tests
Collect
Results
File
Study
Report
THERAPEUTIC
AREA
COST
PER
PATIENT1
Cardiovascular
$34k
Central
Nervous
System
$42k
Obesity/Diabetes
$50k
Oncology
$73k
Clinical Development is Expensive and Difficult:
10. PROBLEM
10
Recruit
Subjects
Administer
Tests
Imaging
Process
Collect
Results
File
Study
Report
Technologist
Training
Image
Acquisi3on
Data
Transfer
Quality
Control
“Consistent
Image
Quality
is
Difficult
to
Standardize”
31% ERROR RATE among local imaging services1
1Chesbrough, RSNA, 2009
12. IMAGING PROCESS FLOW
12
Imaging Protocol
Development
Imaging Facility
Review/Selection
Imaging Facility
Training/
Certification
Imaging Facility
Activation
Image Acquisition
QA/QC Process
Expert Review
Data Processing
Data Transfer to
Sponsor
Adjudication
QA/QC Cleared
13. MODALITY EXPERIENCE
IRC has the experience to partner with Sponsors for studies in all areas of clinical
trials. Our staff has the experience to detect and quantify changes using various
response evaluation criteria for a wide range of modalities:
Using the 3D information available from imaging modalities such as CT and MR,
we can conduct sensitive measurements of volume, blood flow, and vascular
permeability. These measurements provide us with greater insight into
compound mechanism and efficacy.
¡ X-Ray
¡ DEXA
¡ CT/qCT
¡ MRI
¡ PET/CT
¡ Ultrasound
18. CROSS SECTIONAL IMAGING
² Axial MRI and CT Slices
² In-vivo Visualization of Tissue
² Validation Against Cadavers
² CT and MRI Cross-Validated
² 3-Dimensional Reconstruction
(Mitsiopoulous N et al., J. Appl. Physiol, 1998; Gallagher D et al., Am J Physiol., 1998)
