GPC Commercial Use Updates and Developments
undefined
G
P
C
C
o
m
m
e
r
c
i
a
l
U
s
e
U
p
d
a
t
e
s
G
P
C
L
E
C
M
a
y
1
1
t
h
2
0
2
3
Xiaofan Niu & Deandra Cassone
G
P
C
C
o
m
m
e
r
c
i
a
l
U
s
e
D
e
v
e
l
o
p
&
U
p
d
a
t
e
B
a
c
k
g
r
o
u
n
d
B
a
c
k
g
r
o
u
n
d
O
t
h
e
r
C
R
N
p
o
l
i
c
i
e
s
◦
DCRI currently leverages the PCORnet
DSA (no commercial restrictions)
◦
Limit the nature of the studies by requiring
an internal investigator
◦
Aggregated results, n
o
line-item data
◦
No data brokers
◦
STAR
◦
Use the Prime’s contract and data use
language
◦
Has a DSA for sharing aggregate data with
industry
◦
PaTH
◦
PaTH only returns aggregate results
C
u
r
r
e
n
t
G
P
C
G
r
o
u
n
d
R
u
l
e
s
◦
NDA (2-way or 3-way)
◦
Define Qualified Faculty
Member and Affiliate Institution
and require PI at GPC sites
◦
DTUA modification and
execution
◦
ROA & DROC
◦
External Institution Collaborator
Agreement
◦
Line-item data stay at lead sites
◦
No data brokers
C
o
m
m
e
r
c
i
a
l
U
s
e
C
a
s
e
s
–
A
g
g
r
e
g
a
t
e
o
r
D
e
-
I
d
D
a
t
a
◦
Use Case: Aggregate or De-identified Data Maintained at
Lead Site
◦
Meet General Operating Requirements
◦
Lead sites facilitate the query development and customization
◦
DROC request is submitted by lead site noting commercial
engagement
◦
Case A
: Sites return aggregate results to lead GPC site
◦
Case B
: Sites return de-identified data to lead GPC site
◦
DTUA, Attachment 1 and Attachment 2 are modified for
commercial engagement
C
o
m
m
e
r
c
i
a
l
U
s
e
C
a
s
e
s
–
C
o
m
m
e
r
c
i
a
l
/
G
P
C
S
i
t
e
T
e
a
m
◦
Use Case: Commercial Company Working in Cooperation
with GPC Investigator at any GPC Site
◦
Meet General Operating Requirements
◦
Commercial sponsors sign an External Institution Collaborator
Agreement (EICA) and identify a qualified faculty member at the
lead site
◦
Qualified GPC faculty investigators lead the studies and submit
DROC requests for feasibility counts for the sponsors
◦
An addendum to the GPC EICA allows sites to “consent” or “opt-in”
to the projects
◦
DTUA, Attachment 1 and Attachment 2 are modified for
commercial engagement
C
o
m
m
e
r
c
i
a
l
U
s
e
C
a
s
e
s
–
G
R
O
U
S
E
/
D
e
-
I
D
G
P
C
D
a
t
a
◦
Use Case: Commercial Seat on the GROUSE Environment Working
with GPC GROUSE Expert.
◦
Meet General Operating Requirements
◦
Commercial companies are required to sign an EICA
◦
GPC GROUSE expert(s) involvement is mandatory
◦
An addendum to the GPC EICA allows sites to “consent” or “opt-in”
to the project
◦
DTUA, Attachment 1 and Attachment 2 are modified for
commercial engagement
◦
Ruffed GROUSE only (exclude CMS claims)
(Ruffed Grouse)
B
u
d
g
e
t
i
n
g
C
o
n
s
i
d
e
r
a
t
i
o
n
s
◦
Include Increased Infrastructure Cost
Recovery Fee (example 25%)
◦
Include flat industry data use fee (example
$15k)
◦
Other cost considerations?
◦
PCORnet Query Pricing Model
◦
Leverage PCORnet query pricing model, when
completed
◦
Industry pricing is typically 20-30% higher than
academic pricing
◦
More funding available
◦
Tighter delivery timelines
First GPC Industry Sponsored
Study (First Use Case Scenario)
◦
Otsuka Autosomal Dominant Polycystic Kidney Disease
(ADPKD) study.
◦
De-ID data requested by Utah investigators
◦
Three-way NDA (Utah, Otsuka, GPC Central)
◦
GPC DSA (Attachment 1 with project details) between Utah
and GPC Central
◦
Query was developed by Utah and GPC Central
◦
ROA Committee screening and approval SOW
◦
Rapid PACE
First GPC Industry Sponsored Study
First GPC Industry Sponsored
Study
◦
Success:
DROC 115 noting commercial sponsored
◦
DROC 115 query modification, re-distribution, increased
payment
◦
Sites very supportive and patient
◦
Learning opportunity for the Investigators
◦
Utah as the lead site is able to disperse payments without
going through GPC Central
◦
Challenge
:
site internal data sharing policy and IRB
policy on industry sponsored studies could delay
participation
Near Term
Opportunities
Discussion
•
Possibility of using i2b2 for feasibility request?
•
Flat rate for feasibility?
•
Other budget considerations?
•
Other recommendations?
P
r
o
p
o
s
e
d
G
P
C
C
o
m
m
e
r
c
i
a
l
U
s
e
R
e
q
u
i
r
e
m
e
n
t
s
General Operating Requirements
◦
Lead site executes a Non-Disclosure Agreement with
the commercial entity (2-way or 3-way depending on
lead site)
◦
Require a GPC investigator to lead any project as a
qualified faculty member
◦
No line-item data shared with the commercial partners
◦
No “third party” relationships would be allowed so that
all participants are identified
P
r
o
p
o
s
e
d
G
P
C
C
o
m
m
e
r
c
i
a
l
U
s
e
R
e
q
u
i
r
e
m
e
n
t
s
(
c
o
n
t
.
)
General Operating Requirements
◦
Identification of a commercial sponsor on ROA & DROC
◦
Requires modification to Exhibit B GPC Data Transfer and Use
Agreement
◦
Attachment 1 – Project Specific Information
◦
Description of Data
◦
Description of Project
◦
GPC Coordinator/Accepting Provider(s) Identification
◦
Reimbursement Costs (Site SOW)
◦
Attachment 2 – Data Specific Terms
◦
Additional terms (no line-item data and complies with DTUA)
Information regarding the latest updates and developments in GPC's commercial use cases, requirements, and engagement opportunities. Topics covered include background information, current ground rules, commercial use cases, and data handling practices.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
GPC GPC Commercial Use Commercial Use Updates Updates May 11th th 2023 GPC LEC May 11 Xiaofan Niu & Deandra Cassone 2023
GPC Commercial Use Develop & GPC Commercial Use Develop & Update Update Background Proposed GPC Commercial Use Requirements GPC Commercial Use Cases (Three Cases) Budgeting Considerations First Application & Incoming Oppotunities Discussion
Background Background Informa Several commercial entities approached to engage with GPC sites and leverage our data PRECISIONheor Otsuka & Novartis Duke Other CRNs Commercial Use Restrictions PaTH STAR NDA MU Legal GPC DUA Clarification & modification EICA
DCRI currently leverages the PCORnet DSA (no commercial restrictions) Limit the nature of the studies by requiring an internal investigator Aggregated results, no line-item data No data brokers STAR Use the Prime s contract and data use language Has a DSA for sharing aggregate data with industry PaTH PaTH only returns aggregate results Background Background Other CRN Other CRN policies policies
Current GPC Current GPC Ground Rules Ground Rules NDA (2-way or 3-way) Define Qualified Faculty Member and Affiliate Institution and require PI at GPC sites DTUA modification and execution ROA & DROC External Institution Collaborator Agreement Line-item data stay at lead sites No data brokers
Commercial Use Cases Commercial Use Cases Aggregate or De Aggregate or De- -Id Data Id Data Use Case: Aggregate or De-identified Data Maintained at Lead Site Meet General Operating Requirements Lead sites facilitate the query development and customization DROC request is submitted by lead site noting commercial engagement Case A: Sites return aggregate results to lead GPC site Case B: Sites return de-identified data to lead GPC site DTUA, Attachment 1 and Attachment 2 are modified for commercial engagement
Commercial Use Cases Commercial Use Cases Commercial/GPC Site Team Commercial/GPC Site Team Use Case: Commercial Company Working in Cooperation with GPC Investigator at any GPC Site Meet General Operating Requirements Commercial sponsors sign an External Institution Collaborator Agreement (EICA) and identify a qualified faculty member at the lead site Qualified GPC faculty investigators lead the studies and submit DROC requests for feasibility counts for the sponsors An addendum to the GPC EICA allows sites to consent or opt-in to the projects DTUA, Attachment 1 and Attachment 2 are modified for commercial engagement
Commercial Use Cases Commercial Use Cases GROUSE/De GROUSE/De- -ID GPC Data Use Case: Commercial Seat on the GROUSE Environment Working with GPC GROUSE Expert. Meet General Operating Requirements Commercial companies are required to sign an EICA GPC GROUSE expert(s) involvement is mandatory An addendum to the GPC EICA allows sites to consent or opt-in to the project DTUA, Attachment 1 and Attachment 2 are modified for commercial engagement Ruffed GROUSE only (exclude CMS claims) ID GPC Data (Ruffed Grouse)
Budgeting Budgeting Considerations Considerations Include Increased Infrastructure Cost Recovery Fee (example 25%) Include flat industry data use fee (example $15k) Other cost considerations? PCORnet Query Pricing Model Leverage PCORnet query pricing model, when completed Industry pricing is typically 20-30% higher than academic pricing More funding available Tighter delivery timelines
First GPC Industry Sponsored Study (First Use Case Scenario) Otsuka Autosomal Dominant Polycystic Kidney Disease (ADPKD) study. De-ID data requested by Utah investigators Three-way NDA (Utah, Otsuka, GPC Central) GPC DSA (Attachment 1 with project details) between Utah and GPC Central Query was developed by Utah and GPC Central ROA Committee screening and approval SOW Rapid PACE
First GPC Industry Sponsored Study Success: DROC 115 noting commercial sponsored DROC 115 query modification, re-distribution, increased payment Sites very supportive and patient Learning opportunity for the Investigators Utah as the lead site is able to disperse payments without going through GPC Central Challenge: site internal data sharing policy and IRB policy on industry sponsored studies could delay participation
Novartis - Heart Failure feasibility counts (NDA & DSA signed) Siemens Varian Cardiac Arrhythmia Ablation Treatment study - feasibility counts (NDA &DSA signed) Near Term Opportunities Others Studies with brokers or middle-men with companies such as PRECISIONheor and IQVIA These types of studies don t align with our current collaborative model of working with the actual sponsors.
Discussion Possibility of using i2b2 for feasibility request? Flat rate for feasibility? Other budget considerations? Other recommendations?
General Operating Requirements Lead site executes a Non-Disclosure Agreement with the commercial entity (2-way or 3-way depending on lead site) Require a GPC investigator to lead any project as a qualified faculty member No line-item data shared with the commercial partners No third party relationships would be allowed so that all participants are identified Proposed GPC Commercial Use Proposed GPC Commercial Use Requirements Requirements
General Operating Requirements Identification of a commercial sponsor on ROA & DROC Requires modification to Exhibit B GPC Data Transfer and Use Agreement Attachment 1 Project Specific Information Description of Data Description of Project GPC Coordinator/Accepting Provider(s) Identification Reimbursement Costs (Site SOW) Attachment 2 Data Specific Terms Additional terms (no line-item data and complies with DTUA) Proposed GPC Commercial Use Proposed GPC Commercial Use Requirements (cont.) Requirements (cont.)
