The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for a single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.

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January 22-24, 2018 | Washington, DC
Pharmacovigilance and Risk Management
Strategies Conference

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3. An Industry Collaboration’s Perspective on
the Value of Patient Support Programs,
Market Research Programs, and Social
Media
Peter Verdru, MD
Vice President, Head of Patient Safety, UCB
TransCelerate Initiative Leader, Value of Safety Information Data Sources
Jeremy Jokinen, PhD, MS
Senior Director, Safety Decision Analytics, AbbVie
TransCelerate Workstream Leader, Inventory of Evidence

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TransCelerate Overview
Our vision
To improve the health of people around the
world by accelerating and simplifying the
research and development of innovative
new therapies.
Our mission
To collaborate across the global research
and development community to identify,
prioritize, design and facilitate
implementation of solutions designed to
drive the efficient, effective and high quality
delivery of new medicines.
Founded in 2012 by
10 Members
TransCelerate is a not-for profit entity created to drive collaboration

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A Challenge in Pharmacovigilance
*Data from FAERS Public Dashboard
The number of adverse events collected by pharmaceutical
companies and reported to regulatory authorities is increasing by
10 - 20% per year, driven by both an increase in reporting by
individual patients and health care providers, as well as by an
increase in reporting through patient support programs, social
media, etc.
This has raised a specific challenge: there is no evidence that this
volume growth has resulted in a more rapid signal detection; in
fact, given the increasing amount of effort required to collect,
analyze, and report this data, the possibility exists that the ability
to detect a new safety risk may be hindered.
0
600
1200
1800
ReportCount(thousands)
Adverse Event Reports in FAERS for the
Past 15 Years
A rapidly increasing volume of AE reports are
driving challenges for patient safety in
pharmacovigilance

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The Value of Safety Information Data
Sources Initiative
Value of Safety Information Data
Sources
This initiative will identify sources of
safety information for single high
value valid cases and develop a
proposed method for management
of lower value cases to present to
the regulators.
Near-term Objectives (2017)
• Identify and reconcile adverse events data source
definitions
• Create hierarchy of value for collecting,
processing, analyzing, and reporting adverse
event information
Long-term Objectives (2018+)
• Improve patient safety through sharpened focus
on the highest value safety information
• Align with health authorities on evidence-based
collecting, processing, analyzing, and reporting of
adverse event information

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Our Hypothesis and Approach to Gathering
Evidence
Safety information from patient support programs, markets
research programs, and social media are of low value
Four Pillars of
Evidence:
Label changes
due to valid /
confirmed
signals
1
Similarity of
safety
information
2
Quality of safety
information
3
Overwhelming
databases with
low value cases
limits signals
detection
4
Hypothesis:

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Data Source Definitions
Patient Support Program
A patient support programme is an organised system where a marketing authorisation holder receives and collects information relating to the use
of its medicinal products. Examples are post-authorisation patient support and disease management programmes, surveys of patients and
healthcare providers, information gathering on patient compliance, or compensation/re-imbursement schemes. [GVP Module VI.C.2]
Market Research Program
A market research programme refers to the systematic collection, recording and analysis by a marketing authorisation holder of data and findings
about its medicinal products, relevant for marketing and business development. [GVP Module VI.C.2]
Social Media
Websites and applications not under the control of the sponsor that enable users to create and share content or to participate in social
networking, such as Twitter, Facebook, LinkedIn, Pinterest, or Company websites that allow for user engagement. Control means authority over
the final content.
Patient Assistance Program
Any project with the aim of patient assistance in the form of compensation/reimbursement schemes which is solely charitable in
design, without intent to collect information relating to the use of the medicinal product. PAPs may provide free or discounted medicines
to low-to-moderate income, uninsured and under-insured people who meet specific guidelines. Note: Patient Assistance Programs that
collect information relating to the use of the medicinal products involved are handled as PSPs for the purposes of safety data collection;
some companies distinguish between Patient Support and Patient Assistance Programs.
A broad definition of PSPs was
in part used for this analysis to
facilitate data extraction

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1. Valid / Confirmed Signals Resulting in
a Label Update
Our approach:
Ten companies responded to a survey intended to identify whether valid or
confirmed signals from patient support programs, market research programs, or
social media resulted in a label update.
1
10
100
1,000
10,000
100,000
1,000,000
10,000,000
Analyzed
Cases
Valid Signals Label Changes
Cases, Signals, and Label Changes
Identified from Patient Support
Programs, Market Research Programs,
and Social Media over a 3 Year Period
• 965,834 patient support
program cases
• 33,601 market research
program cases
• 8,926 social media cases
1,008,361
9
0
No label changes were identified from at least 1
million patient support program, market research
program, and social media cases reported to 10
pharmaceutical companies over a 3 year period
• Analysis of 965,834 patient support program cases, 33,601 market
research program cases, and 8,926 social media cases resulted in the
identification of 9 valid signals and 0 label updates
• Signal Validation: The process of evaluating the data supporting a detected
signal in order to verify that the available documentation contains sufficient
evidence to justify further analysis of the signal. This evaluation should take
into account the strength of the evidence, the clinical relevance and the
previous awareness of the association. [GVP Module IX.A.1]
Participating
Companies: 10
Our findings:

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2. Similarity of Safety Information
Our findings:
Our approach:
Nine companies individually completed a statistical analysis aimed to compare
proportions of reported events by HLGT from patient support programs, market
research programs, and social media to those from spontaneous data sources to
gain insights on the types of information being reported.
Generally, our analysis shows that patient support
programs, market research programs, and social
media do not create additional opportunities to
better understand the safety profile
Spontaneous PSP MRP SM Total
Cases 359,067 202,589 8,669 5,706 1,250,399
Events 742,797 482,017 14,059 14,437 1,320,834
• While results varied slightly across companies, similar proportional rates
for HLGT to spontaneous sources were observed for each solicited source
• Minimum cases and events analyzed:
Sample Plot:
This company has consented to share this plot for purposes of this
presentation. TransCelerate members were not provided access to
other members’ data in connection with this analysis.
Participating
Companies: 9

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3. Quality of Safety Information
Market research programs and social media
consistently displayed very low quality
Patient support programs displayed a higher
quality comparable to spontaneous sources
Our approach:
Nine companies individually completed a statistical analysis using the vigiGrade
scoring method developed by Bergvall et al. to evaluate completeness (quality)
of reports from patient support programs, market research programs, social
media, and spontaneous data sources.
• Market research programs and social media tended to display a similar
profile to each other and to display a much lower quality than spontaneous
sources.
• Patient support programs tend to have a very similar quality score and
profile to spontaneous sources.
• Reports by HCPs did not tend to contain superior quality compared to
reports by consumers.
• There are many different types of patient support programs and this
may have contributed to the high quality score.
Sample Plot:
This company has consented to share this plot for purposes of this
presentation. TransCelerate members were not provided access to
other members’ data in connection with this analysis.
Histograms of vigiGrade Scores for Each Case Type
Participating
Companies: 9
Our findings:

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3. Quality of Safety Information: Details
Box and Whisker Plots
This company has consented to share this plot for purposes of this presentation. TransCelerate members were not provided access to other members’ data
in connection with this analysis.
Sample Plot:

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Conclusions
Market research programs and social media displayed
very low quality. Patient support programs tended to
display a higher and similar quality to spontaneous
sources
Market research programs
and social media are of low
value
No label changes were identified from patient support
programs, market research programs, or social media
Patient support programs, market research programs, and
social media did not appear to create additional
opportunities to better understand the safety profile.
Patient support programs
should be broken down by
type and analyzed

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