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Promoting Clinical Trial Data Transparency
Conference
March 30-31, 2015, Harvard Faculty Club
-1-
MRCT Data Sharing Conference
Pre-Conference Survey Findings
March 30, 2015
Promoting Clinical Trial Data Transparency:
Results of Pre-Conference Survey
The pre-conference survey focused on commonalities,
limitations and gaps of current data sharing approaches
Survey
Participants
Industry 10
Foundation/Journal 6
Academic/IRB 5
A total of 21 interviews
were conducted over two
months to identify
commonalities, limitations
and gaps of current data
sharing approaches. Each
organization identified
one individual to be
interviewed for responses.
3
Copyright © 2015 Deloitte Development LLC. All rights reserved.
Common principles were identified for sharing of
participant level clinical trial data
Core Principles.
Promote sharing of data to advance science and improve public health while
 protecting patient rights and privacy
 ensuring responsible conduct of research and good stewardship of data
 maintaining incentives for those who generate data to conduct new research
4
Copyright © 2015 Deloitte Development LLC. All rights reserved.
The value of data sharing is strongly supported, but
specifics of what data to share varies
100%
Although all survey respondents
were supportive of data sharing
there were a variety of different
opinions around what it means to
share participant level data
Of respondents
support data
sharing and the
aggregation of data
Spectrum of data sharing
Making all
data available
5
Data made
available on
request
Data available on request
after internal review for
legal and competitive risk
Copyright © 2015 Deloitte Development LLC. All rights reserved.
A central system that allows interoperability is widely
considered to be the preferred option however many
challenges need to be addressed
System Requirements
Current System Gaps
90
4 x 2.2 %
GHz
RAM
Prefer2a GB
privately-run
1 system
TB SSD vs. a
central
federated model
6
Common Data
Standards
Standard Data Use
Agreements
Protected Personal
Information
Standard
Processes
Cross-Sponsor
Solutions
Analytical Tools

Use of a common data standard

Resources to anonymize data

Data repository for academics

User friendly system

Ability to combine data easily

Common criteria or common
review board
Copyright © 2015 Deloitte Development LLC. All rights reserved.
To improve transparency, sponsors plan to or
currently publish metrics of requests and track
reasons for denials
Number of
# incomplete or
# in process # approved # denied
Monthly Average Time period
requests
withdrawn
CSDR*
92
38
37
4
13
4.6
5/2013 – 12/2014
Pfizer
15
3
8
0
4
1.25
1/2014 – 12/2014
YODA
9
1
8
0
0
1.8
10/2014 – 2/2015
Total
116
42
53
4
17
*Note CSDR data is an aggregate of 11 sponsors
Source
93%
Of Data
Requests have
been approved
7
Reasons for denying a request for data include:








Proposal lacks clear scientific merit
Data requested is not appropriate for the study proposal
DUA was not signed
Project aim is commercial or litigious
Out of scope for what is to be shared per policy
Out of scope for informed consent
Studies still in conduct
Not seeking access to anonymized patient level data
Copyright © 2015 Deloitte Development LLC. All rights reserved.
To achieve a shared vision for an interoperable system
key process points should be harmonized
Proposal
Review
IT Platform
Upload Data
 Availability
 Meta-data
 Anonymize data
Proposal
to use data
Evaluate Proposal
and Team
 Scope
 Patient Consent
 Statistician
 Data availability
 Privacy protection
System Framework
 Ability to analyze
multiple studies
 Governance of
data systems
 Portal access
 Model for
sustainability
Data Available
for Proposal
End of Study
Requirements
 Publication plan
 IP review
 Manuscript review
 Data available for
secondary analysis
Data
Generator
8
Copyright © 2015 Deloitte Development LLC. All rights reserved.