Hello everyone. Thank you for your patience
and welcome to the webinar titled Identifying
Safety Signals By Data Mining The FDA Adverse
Event Report System With Oracle Empirica Signal
present by Chris Wocosky, an expert in signal
detection and management at Perficient.
I'm Eugene Sefanov, the marketing manager
for Perficient's life sciences business unit
and before I turn it over to Chris, I would
like to go over some housekeeping items.
During the presentation, all participants
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If you still have unanswered questions after
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This concludes our housekeeping items. I would
now like to turn the call over to Chris Wocosky.
Hello everyone. Good morning, good afternoon,
good evening to wherever you may be in the,
around the world. Thanks for joining me and
for your interest in hearing about Oracle's
Empirica Signal.
Let's see. So, just a couple of slides about
Perficient. Some of you may know about, may
know us as BioPharm. We were just recently
acquired by Perficient and they have sites
all over North America and Europe and India
and China.
Perficient was founded in 1997. It's a public
company with about 2,100 colleagues globally.
Our, our solution expertise from BioPharm
now fits into the life science business unit
for pharmacovigilance and safety in the, as
a vertical in Perficient's organization and
will continue to provide consulting, implementation,
integration, upgrade migration and hosting
services for the most widely used and highly
sought-after drug safety pharmacovigilance
and risk management signal systems in the
world.
And, again, the products we focus on in the
safety and pharmacovigilance arena are the
Argus Safety suite including Argus-Japan,
affiliate interchange, reconciliation, dossier
and insight, Oracle AERS, TMS and the Empirica
Signal and topics applications.
Just some introduction of myself for those
of you who don't know me. I see some familiar
names on the list, but my background is 17
years of industry experience mainly in the
medical device manufacturing area. I worked
for some very large device manufacturers such
as Edward's Life Sciences, formerly Edwards
Laboratory, Abbot-Vascular which was Guidant
at the time I worked there and then J & J
Biosense Webster. My main focus was in cardiovascular
and electrophysiology products. Tissue and
mechanical heart valves, coronary stents,
drug coated stents and ablation catheters.
I started out in Quality and reliability engineering
and worked my way through quality assurance,
regulatory compliance and into complaint management.
I was recruited out of industry to work for
Aris Global. I was there for, oh, a little
under 3 years and then went to Phase Forward.
Phase Forward was purchased by Oracle and
then I just recently joined BioPharm in November.
Some of the safety and pharmacovigilance products
that I am well versed in are Register for
managing your global regulatory applications,
InforMed for medical, medical information
handling and Arisg, as well as ClinTrace,
Empirica Signal, Study and Topics and the
Argus Safety Suite. I have experience in pre-sales
consulting, implementation, consulting and
training.
So, the agenda for today, we're going to,
I'm just going to do a brief background of
Empirica Signal for those of you who may not
be as familiar as others. Talk a little bit
about why, why use Empirica Signal and then
do a comprehensive product overview and I'll
leave time at the end for some Q & A. And,
as Eugene mentioned, those can be submitted
via the chat window. I'll do my best to answer
as many questions as I can, but with the number
of participants, I will follow-up with those
after the conference as time allows.
So, Empirica Signal was developed as a CRADA,
co-operative research and development agreement
between the FDA and Lincoln Technologies back
in between 2003 and 2005, lead by Bill DuMouchel
of Lincoln Technologies and Ana Szarfman from
the FDA.
Their objective at that time was to create
a user-friendly web-based tool for the FDA
to use to look at the safety profiles of the
drugs that were being approved. The product
at that time was called WebVDME and VDME stood
for the web visual data mining environment.
And their conclusion at the end of that agreement
was that this tool assisted in identifying
unusual patterns, however, those patterns
need to be interpreted and that means that
you can't just rely on the numbers that come
out of the system or the things that are presented
to you, but it requires input from your medical
and business partners as well.
So, in 2005, Phase Forward was, acquired Lincoln
Technologies and they re-branded WebVDME as
Empirica Signal. And then in 2010, Oracle
acquired Phase Forward and the product is
still in use today at the FDA.
So, a little bit about the regulatory landscape.
Because of increased focus on technology,
or because of the regulatory landscape, there's
an increased focus on technology to save time
and money, not only for the regulators, but
industry as well. Companies are expected to
do more and they have tighter budgets and
the global requirements are growing. They're
still not harmonized, so there are some differences
in the regulations globally. And there is
an increased focus on safety related issues.
So, just some of the drugs that were withdrawn
in the last 5 years. You can see on this table
here and I'm just going to explain on the
next slide. These drugs were withdrawn from
the market due to the risks to the patients,
serious side effects and these side effects
were mainly unexpected adverse events that
weren't detected during clinical trials, Phase
III trials.
And, they only became apparent from post-market
surveillance data after the products were
used by a wider patient community. The use
of drugs were not limited to drugs that were
ever approved by the FDA. In fact, some were
from other markets that were in approved in
other markets other than the U.S.
So, because of this growing government and
public concern about drug safety, it's increased
the importance of having a robust pharmacovigilance
system. Traditional methods, such as just
reviewing cases are no longer sufficient due
to the increased data volume and complexity
of the cases and products. New strategies
to proactively identify and manage these safety
risks are needed.
And they, we all know this is a highly competitive
and risk-averse environment and it's essential
that regulatory authorities as well as pharmaceutical
companies establish these great robust pharmaceutical
programs, pharmacovigilance programs.
So, the process that was proposed by the CIOMS
VIII working group, I'm not going to go into
the details of this map, but you can see that
the three main areas are signal detection,
signal evaluation and signal prioritization
and there's a specific flow for those identification
of such.
The EMA also developed the guideline for good
pharmacovigilance practice or GVP in module
9 specifically for signal management. And
it states that the signal management process
shall cover all steps from detecting signals
or signal detection through the validation
and confirmation, analysis, prioritization,
and assessment all the way through to recommending
actions, as well as tracking all the steps
taken and any of the recommendations made.
So, it's not good enough just to be aware
of what those signals are, but to document
what your findings are.
The processed mapped out in a module 9 process,
the signal detection piece can be handled
by Empirica Signal and all of the other steps
really can be handled by Empirica Topics.
We do have another webinar specifically on
Empirica Topics, but I'm going to touch on
it in this one as well and give you an overview
of the entire suite Empirica Suite.
So, there's the signal detection, validation,
analysis and prioritization, assessment, recommendation
for action and exchange of information.
So, why use Empirica Signal & Topics? Well,
it's the same tool that was developed and
then is in use today at the FDA as well as
MHRA. It allows you to detect those signals
early or potential signals by looking at the
changes in the profiles of the drug over time.
It allows you to track and document every
step you take from the first moment a potential
signal is identified and then allows you to
monitor, verify, make decisions and take actions
and to document all of that.
And, in the end, with Empirica Topics, it
allows you to provide to regulators with a
PDF of all the necessary information to back
up your decisions. And, I'm sure at some point
in time, you've all heard the phrase: "If
you didn't document it, it didn't happen".
It's not good enough to just say what you
did, you have to show what you did.
So, there's signal detection and signal management.
And, some people use those interchangeably.
There are different areas of Empirica Signal
that you can use to detect signals you can
look for things, kind of like looking for
a needle in a haystack, by looking at all
the different visual tools and then there's
the signal management piece that allows you
to do your routine safety reviews. It serves
up data to you to compare what happened last
quarter to what's happening this quarter and
allows you to use different signal detection
techniques to do that.
It allows you to look at all your marketed
products and how those signals evolve as the
data accumulates over time. And then it allows
you to store public and private comments as
wells as blanket comments from multiple drug
event combinations and those comments are
stored right in the system so that you can
filter out the ones that you have already
commented on and don't need to look at again.
And then, it ultimately allows you to store
all of your findings with all of your other
data sources. All in one place so you have
that comprehensive packet of information that
you've worked up for each potential signal.
So, some of the benefits of using Empirica
Signal: Early detection of potential safety
signals from our marketed drugs. So, if these
are, if this is a tool that the FDA is using,
they're going to find it, why not use the
same tool and be able to find it sooner rather
than later?
There are multiple disproportionality scores
available. You'll see the classic as well
as the Empirica based geometric mean. Signal
has powerful graphical visualizations to facilitate
the medical interpretation. So, rather than
having to learn how to navigate through Empirica
Signal, it really does serve up the information
to you through this easy user interface.
It allows complete drill-down without requiring
any programming. So, the information that
you see on these charts and graphs have the
underlying data just below and most of the
time, you can get to them within one or two
clicks.
It's got built in functionality to address
confounding and to assist in signal assessment
such as stratification as well as logistic
regression and extended logistic regression.
The extensive built in signal management,
tracking and documentation functionality is
also very comprehensive.
So, drug profiles support easy and consistent
drug reviews. The presentations of statistical
and other information about one or more drugs,
generic, trade or ingredient. You don't need
to navigate Empirica Signal like a site, you
can review your drug as a set of predefined
charts and graphs and I'll show how you can
display those in a slide-show mode or in a
desktop view and how you can have multiple
layouts.
It's got the full power of data mining results
in a drill-down without having to navigate
Empirica Signal. It's easy to use tool with
direct access up log-in, there's no need to
use any, to issue any commands to bring the
application up.
The layouts, charts and graphs are configurable
by you to decide what you want to see on the
screen at any one give time. Maybe you're
a person who likes to review a lot of different
things or maybe you want to see them one at
a time and I'll show you how you can do that.
In addition, there is a tab for allowing you
to, with one click, to link to the FDA or
the NIH to review the labeling for the product
that you're reviewing.
So, here's a comprehensive drug profile layout.
To some of you, this might seem very busy,
to others, this might be the way you like
to review it. This is very configurable. So,
we're on the drug profiler page and here you
see drug layout and links. The drug is where
you would select what drug you want to review.
This is the, and let me just back up for a
second.
So, this is on the signal detection side of
the patient where you're, where you're reviewing
the profiler drug and you're looking for,
for, you're investigating the product.
So, you would select the drug that you want
to look at. You select the layout. In this
case, the layout includes these five charts
and graphs. There are many layouts, you can
create many and this is where you would manage
them and you would select which layout you
want to see.
So, the focus is on a particular drug and
the background information or the denominator
data is all of the 5 million plus cases in
the FDA's AERs database and then you can choose
to look at the confidence interval graphs,
cumulative maps graphs, to see the change
in the signal over time. You may want to see
the break down by age group or the break down
by gender and keep in mind, all of these charts
and graphs are, you can drill-down on any
one of them at any given point and time. And,
I'll get into describing the sector map to
you shortly. And, remember here, that anything
that is underlined in blue allows you to drill
through to those, those actual cases there.
So, jut looking at the sector map here on
the left, it allows you to proactively and
quickly manage your safety risks, detect and
quantify signals, by using these advanced
techniques of data mining, and gives you the
most advanced set of tools to develop a well
understood safety profile for each of your
products.
So, the sector map, which was developed by
Lincoln Technologies, also called the heat
map or the tree map, gives you this over-all
comprehensive layout of your particular drug.
So, these large white tiles are the medDRA
system organ classes or SOCs. The smaller
tiles that you see in between there are the
PTs or preferred terms.
And the colors represent the strength of the
signal. So, here you see the legend at the
bottom. The brighter red the signal indicates
that the adverse event signals are significantly
higher than are expected with this drug. And,
the bright green, on the other hand, indicates
significantly less occurrences than expected,
which also could be potential indications
for the drug.
The chart below is ranking in descending order
of the, I think in this case, I have the top
ten. That can be changed. You can look at
more than or less than 10. But, it gives you
the PTs, the rank, the SOCs, the PT terms
and then the score, in this case, we're using
EBGM or Empirical Bayes Geometric Mean. But
you can also choose to use EBO5, Chi or PRR.
And, again, the focus is on a particular drug,
with the background being all the cases in
the FDA AERS database.
So, here's a visual representation and most
people would look at this and focus directly
on this cardiac SOC because of the bright
red areas you see here. And, in fact, this
bright red indicates the cardiac issues with
drug Seldane which was withdrawn ultimately
from the market in 1998. So, it gives a very
easy quick visual that green is good and red
is bad.
So, the size of the PTs, or the smaller tiles,
are based on the public health impact and
the way that's computed is that the number
of times the PT occurs in a serious or fatal
case and the proportion of those cases that
a PT involved a serious or fatal case.
The PTs with a value of the minimum threshold
are included in the sector map and that can
be set by you, so you only want to see anything
over a 1.0 or a 2.0. You'd have to set those
thresholds yourself and it's in the configuration
of the chart.
A higher public impact, public health impact
score corresponds to a larger tile in the
sector map. So, for instance, the cardiac
SOC would have a larger area than the skin.
And the size is based on, oh, since the size
is based on the number of cases in the PT,
of the PT alone, and not the number of cases
that have the PT in a particular drug, the
tile size is stable over the sector map for
different drugs, which allows you to do like
a side-by-side comparison of like drugs or
competitive products to allow you to see the
differences between what areas are effected
with yours and a, and a competitor's product.
So, in this side-by-side comparison, you can
see that even though the drugs are similar,
that different areas, system organ classes
light up in red much more with the drug on
the right than the drug on the left. And there
are more greens areas with the drug on the
left which could lead to alternate indications
for this drug.
Now, you can also zoom in on a sector map.
So, we have the overall sector map here and
let's say we wanted to look at this brightly
lit red area. So, I select that SOC and then
I'm given a menu and you will learn the menus
quickly and easily throughout the system,
they're the same.
So, once I click zoom, I can see another chart
appears. So it takes this tile and it actually
enlarges it. So, now I'm looking at just that
particular SOC and I'm given another menu,
so I can look at the statistics behind that,
all of the PTs in that SOC. It gives me a
list here. I can click and I could view the
cases which would take me right to the cases
themselves. I can create a case series and
save that off it is something of interest
that I think needs more investigation.
I could transfer this cases series to another
case series. And, I can download these details
and I will show you some slides on how that,
on how you can do that. Another nice feature
is then I could also create reports off of
this report, I basically have a report here
and I can create another report.
So, maybe I'm interested in, now that I've
drilled-down into this one PT. Maybe I want
to see the stratification by age or gender
or I want to see what the outcomes were. I'm
able to do that right from this chart and
it would display that report for me. And,
then I could save that report off to Topics
to continue to build my investigation.
So, I mentioned that with the drug, with the
drug profile layout, you could have one or
many charts or charts of different types on
your desktop at one time. So, here's another
view without the sector map. It just shows
the confidence interval graph and then I've
got the distribution by seriousness here.
I've got distribution by outcome here. And,
you can move the charts and graphs and enlarge
and make them smaller. And, then create really
a kind of standard that you would like to
have all, all of your safety reviewers to
review the same, review different products
in the same manner.
You may choose to use the slide-show view
rather than have all of the graphs on your
page at one time. If you're the type of person
that just wants to see one at a time, you
can choose this slide-show view and that will
allow you to view one graph at a time. And
you can still have the same drill-down capabilities
with that. Another example of just one slide
at a time for the slide-show view.
So, the access to the data underlying these
reports are just a click away. As, I mentioned,
the submenus are the same on all the charts
and graphs, so whether I'm in a list here
or whether I'm in a graph here, I have the
same menu that appears. I can click to those
underlying cases for any of the blue and underlined
areas. And, I'm able to download cases or
the details of the cases as well as create
reports.
So, first I click on the, I want to view the
cases, so now I've got a list of cases here.
And, now I've got some other menu items at
the top here. I can create a case series,
transfer, download or create reports, but
now I also have this ability to use, to add
or remove columns, print or download the information.
So, let's select this here and now I'm into
case form itself and I can review all of that
information.
If I choose to download the case details,
I simply select download case details. So,
for this 128 cases, it gives me the bread
crumbs here. It tells me where I got this
information from, this is from run from Q2
of 2008. It's the generic, of chosen generic
and suspect product only and for cyclobenzaprine
and hallucination.
Once I click this download case detail, this
other menus comes up and it allows me to choose
a file name, the data, and it allows me to
choose how I want that information to be downloaded.
I personally like to use Excel, so I have
set my preferences so that every time this
dialogue box pops up, it's going to select
Excel for me. But, I could go through and
change and select another form.
You may even want to view it in with a SAS
training passport viewer. You could select
that as your default or you could just choose
this on the fly as you go through. It also
allows you to create a zip file that goes
along with your download that identifies who
created the information when and the date,
date and time, so it's kind of a time stamp
on the information that goes along with file
and is saved in the audit trail so you know
exactly what was created by whom and when.
And then, the output really is your, whether
it's Excel file or whether it's a SAS transport
file, RTS, DBS, it gives you a workbook here
with all of the information all tied together
by the IFR number. So, in this case, I've
got the event date, the manufacturing date,
really, whatever information is stored in
the case form itself.
Here's an example of some of the other analytics,
graphics that are used for safety review.
Here's a gender break-down, a chart and, again,
you can drill-down into these charts as well
as you can into the tables. The sector map,
a inter-drug interaction map here with the
confidence interval overlaid.
And, then, here you can look at the kind of
trending information from, compare all data
to just the data in the UF and how that signal
looks over time. And, then, again at the bottom
here, it's got the, the information in tabular
form.
Another example of some information on how
it would, is displayed.
So, in addition to being able to have that
information readily served up to you and,
again, that information comes from the FDA
AERS data. It's available to you on a quarterly
basis. I think I have a slide later on in
the presentation that tells how that data
is prepared and how it's made available. But,
it's made available quarterly and you can,
you'll know which quarter of data you're using
because you select that as you create these
queries.
But, it also allows for you to do additional
querying, reporting on a case series with
using this case series wizard. And, what you
would do here is selecting your variables.
You've got your options to make selections
or use saved lists. And, then after you've
selected your variables, you can edit the
query logic from those more advanced folks.
You can edit, edit your queries here and edit
your logic using, for instance, I want 1 and
2 and 3 or 1, 2 or 3.
It's got a flexible reporting tabulation tool
that allows you to visualize the data in different
ways.
And then the Empirica, let's move into from
the signal detection kind of part to the Empirica
Signal management dashboard. And, so what
the dashboard does is it supports strategic
pharmacovigilance. It helps the drug safety
group prioritize their work and focus on the
areas with the greatest impact.
It combines signal stores, scores with metrics
based on case counts and changes over time.
It's got easy to use tables and graphs in
the interface along with the workflow and
annotation tools. So, it allows you to move
things into a certain, into a certain workflow
path that has been defined and then annotate
those, each of those signals into either to
allow them to be publically viewed or privately
viewed.
So, the table that you see in the background
here, this drug event combinations, is on
the signal stamp and this is a, excuse me,
this is an optional module having this signals
tab and it actually lays out the information
for you so you can see the drug, the SOC,
the event and then the changes in the signal
over time and using different scores.
These can also be sorted ascending or descending
to bring the top scores to the top. You can
group them by drug type, by the reviewer.
Say I only want to see the things that I'm
responsible for, or maybe my group. I can
put, select a particular drug here to only,
you know, review one drug at a time. And,
I can even sort it down to a particular SOC.
So, it allows you to see the things that are
most important and are easy to go through
and identify what needs to be looked at and
make comments here and annotate them.
As far as the comments and annotations goes,
you can annotate the drug, the drug event
combination and case level. It permits both
free-text and controlled vocabulary comments,
however you choose to implement that. It's
configurable and a very convenient way to
build and share, share knowledge. So, in this
case, these are the, these are the way that
the items have been labeled, but that's configurable
by you as well.
So, the capabilities of Empirica Signal. So,
for data mining and statistics it allows you
to see the disproportionality statistics include
the empirical Bayes estimates of relative
reporting rate, or the EBGM and the non-Bayesian
classic such as PRR and ROR.
You also have the advanced logistic regression
that uses the adverse event as a response
variable. You've got graphical and tabular
presentation of results. It makes it easy.
Some people like to see graphical information
and some people like to see a tabular.
And, you've got great access to the safety
data. It's not difficult to drill-down and
get the case data from those graphs and tables
or to download those signal scores and case
data. And it's available for both public and
private safety databases. So, I see some of
the questions coming up do I have to use Argus.
No, you don't have to use Argus. It can be
used with other systems, with your individual
company's databases as well as the public
databases that are available.
The querying reporting capabilities allow
you to see the aggregate as well as the line
listing reports. It gives you a standard library
of standard reports, such as I mentioned age,
gender, outcome, many choices for reports
there. It also allows you to drill-down and
download and publish all the information.
If you're using Empirica Topics, you can save
all that information off to Topics. Again,
that's an optional module. It's, and it's
based on licensing capabilities, so it's all
included in the product, but it's how you
license it that allows you to use either the
signal detection, the signal management portion
and the Topics portion.
It's a fully web-based application environment.
All processing is done on the server and it
can be provided as a hosted service as well.
It's a simple web-client and operates through
firewalls.
So, the optional capabilities that I mentioned
for signal management includes the extended
functionality for your routine, on-going review
by your safety evaluators. Those tables that
actually serve up the information to you that
allow you to sort and bring the most important
things to the top and prioritize what areas
you focus on.
Combinations of different disproportionality
measures with other relevant information such
as listedness, fatal outcomes, all of those
things allow you to enhance the review process
and really bring all of those things together.
What's really the purpose of being timely
detection of signals for your marketed products
while minimizing the overall monitoring effort.
So, being able to do more of technology allows
you to do more in less time. And really bring
those important things to the top for your
business and medical personnel to focus their
efforts on.
So, you're able to easily to detect the changes
in signal scores over time. Allows for structured
online assessments. They don't have to be,
you know, sitting in an office, they can do
this from home, wherever they need to access
the data, it's available as a web tool. They
can print things, take it off in a plane with
them and then come back and update the information
in the system at a later time.
It allows you to prioritize, track and document
all of your signals if you're using the optional
Topics tool. And, again, the drill-down easily
being able to drill-down into the adverse
events and underlying reports.
The capabilities of Topics provides the workflow,
the auditing and the tracking of potential
signals. You can use Topics as a stand-alone
tool, it doesn't, you don't have to use the
entire suite of tools. You can just use Topics
if you want to use it with some other system
that you already have and just use it as a
tracking tool.
It supports attachments from multiple sources
from either inside Empirica Signal or from
other sources, files, website references,
URLs, any of those things can be attached
in the Topics portion of the application.
And Topics is where you have your workflow
assignment and deadline capabilities or you
can assign actions for individuals to, to
do perhaps more investigation, so the safety
reviewer would identify things and then assign
other people to, to go bring back additional
information and then store that in Topic within
the tool.
Gives you great visibility and that's controlled
in great detail and at any point and time,
you can create a PDF file or a zip file with
whatever information you have at that point
and time. And, it saves everything from the
first time it's identified as a potential
signal, at some point, it may turn into a
signal or it may be decided that's it not
a signal and you can document your decision
there as well.
And then you can provide that one page or
one document, not one page, however many pages
it takes to capture all of that information.
But, it can be presented to a regulator, perhaps
used internally as the signal develops over
time, bring that to meetings and discuss with
the colleagues and decide the next steps for
that item.
So, again, the key features of tool: Customizable,
easy to use, the drug profiler is the things
we talked about the most there. Being able
to see all the different charts and graphs
and be able to see the safety profile of your
drug.
Enhanced, configurable workflow. It's got
a support for the full range of statistical
techniques, whatever you choose to use, and
you're not stuck with just using one, that
can be changed every time you look at the
sector map, for instance, you can change the
statistic.
It's got the Bayesian multi-Gamma Poisson
Shrinker that is an interaction calculation
that runs with three or more dimensions. You
have direct access to the safety data through
the drill-down and case series features. Very
stream-lined interface. Interactive reporting
with parameter driven case selection.
And, then options to download that data, like
I mentioned, with either Microsoft Excel,
PDF, Rich-Test Format, however you choose
to whether you use SAS, however you choose.
And, another thing I wanted to mention was
the comprehensive online help. It's context
sensitive, so anywhere you want in the system,
you select the help and it will explain where
you are as far as, even as far down as some,
the, if you wanted to know more about the
algorithms and how they work, it's a complete
explanation and example of how the, how each
of the algorithms works. So, the help is very
powerful.
Again, the key benefits to being able to identify
and monitor safety trends using the same tools
that are used by some of the regulators. Prioritize
and execute critical pharmacovigilance activities,
employ a wide variety of classical and Bayesian
techniques for data mining, allows you to
analyze both the drug/event combinations and
drug/drug interactions, you can filter out
false positives and focus on the most important
risks, allows you to detect problems that
may have been overlooked during clinical development.
And, I might mention here, that we, that there's
also another Oracle product that, called Empirica
Study that is used for detecting adverse events
in clinical trials.
It allows to gather intelligence on competing
drugs, comparing drug safety profiles, seeing
the differences between what you're seeing
with yours and perhaps other products like
yours on the market. Helps you to maintain
a comprehensive history of all the safety
related topics that you have identified, how
you manage them, what actions you've taken,
and what the final outcome is. And, then track
and manage signals in a regulatory compliant
environment.
So, the offerings that we provide at Perficient
are hosting of Empirica Signal, whether you
use Empirica Signal, the signal management
module and/or the Topics module. We provide
training and we help with the integration
between Argus or other products into the mart
and then into Empirica Signal so you can look
at your own data as well as the data that's
provided by these public data sources, such
as FDA. And then, ultimately, integrating
to Topics so that you can have that workflow
and document tracking tool.
How the data provisioning services works is
that there are subscriptions. Like I mentioned,
there's the quarterly subscription, FDA AERS,
FDA FOI data is available from 1968- present.
The VERS data from 1990 to present. There's
the WHO Vigibase data from 1968, and then
as I mentioned in-house, corporate adverse
event databases and occasional spiking of
the in-house data into public data sources.
And, those can all be, we can discuss those
if you're interested in, just send in some,
send me a request and we'll get that information
to you.
So, I know we covered a lot of ground. I see
a lot of questions here. I don't know if,
if you've identified some questions there
for me.
Sure, sure. Thanks Chris.
Mmm-hmm
As a reminder, everyone can ask questions
via the chat feature. In the mean time, we'll
get started. I'll be asking the questions
as they are stated so please be aware.
First question is: The focus of this presentation
seems to be drugs, but wouldn't signal detection
and management also apply to devices?
Very good question. Yes, in fact, there is
some effort going on with the FDA at this
time to look into how we can use the tool
to mine devices. I know there have been a
couple of one-offs where they done some work
with, I know Oracle has done some work with
some device companies. But, as you know if
you're a device company, the MOD database
isn't really mineable as it is. It's not,
it doesn't have the cleaning process that
the AERS database has.
So, there is some effort going on there and
there is some, some capability to use Signal
with devices and be happy to give you some
more information about that if you submit
that request to me. I would be happy to do
that.
Thank you Chris. Just as a reminder, you can
also view the questions at just the follow
line.
Oh, yep, yep
in case I didn't read it.
Next question is: Could you please clarify
which is the denominator used to calculate
the EBGM? It is total of the specific AE observed
without the other drugs in the database or
what?
Yeah, the background data is all, in this
case that I was talking about, was the FDA
AERS database. It could be the Who Vigibase
or your corporate in-house database. But,
it would be all of, all of the cases and you're
looking at focusing on a particular drug as
your numerator data. So, your drug with the
background of all, all the cases that have
been submitted.
Next question: What is the data structure
and/or data sets format including variables
needed, that is needed or required to use
Empirica Signal? All steps. Just as a reminder,
this presentation is being distributed afterwards,
to answer the second question.
Yes, we will be providing the, actually Eugene
will be providing it after the with, I think
he said, within 24 hours he would have that
back to you.
In the data structure format, it's actually
the, whatever information is in AERS is what
you will see. So you don't have to, there's
no inputs that you have to put in. You would
just select the variables that you want to
see if you choose to do those additional data
mining runs or queries.
And, we provide training on how to do that.
Does the system process the structure data?
Hmmm. Again, the data that you get is the
data that has been put into the FDA AERS database,
so whatever those fields are that are like
comments fields or things like that, you'll,
it'll be able to provide you with whatever
information is there.
Can you include a denominator, for example,
sales data or do you rely on disproportionality?
Yeah, we've had that asked as well before,
especially with devices. People typically
want to look at either sales or shipment numbers
and I know that they've done some work on
that. Again, that would be something we could
provide some more information at a later time.
Okay, let's see.
Yeah, I'm trying to
How are signals identified from, for example,
spontaneous reports or regulatory class, imported
into Signal and the management modules? The
vast majority of signals from out company
is not identified from Empirica.
Ummm, I'm not sure I understand that question,
so utilizing signal these would be spontaneous
cases that are provided to, that are in the
AERS database, and so you're, you're looking
at your drug and finding things that are reported
there.
If it's, it's sounds like if you have Products
that are not recorded in the AERS database,
then maybe you would want to mine your own
corporate database to look at those signals.
And we could, I could answer more in depth
on that on an individual basis.
Next. Is it possible to use the FDA AERS database
as the background? For example, use the reports
in our company data set and compare it with
the FDA data set. This way, the non-serious
reports are included in the calculation.
Yeah. We do have people that do that. They
use, they can focus on their internal database
and look at those signals that they get there
Vs the cases that are in the FDA AERS database.
So, yes you can look at both. You can use
the tool for both.
Is it possible to search data the other way
around? By searching, organizing the data
by safety signal then seeing which drug linked
to that signal?
Hmmm, I would have to see what you, what you
mean by that. That might take some more looking
into that a little bit deeper.
Yeah, that was asked earlier in the presentation,
so it's kind of hard to figure out exactly.
Yeah.
Next question is: What do you mean by spiking
of in-house data with other sources?
Okay. So, that would be like where you would
use your in-house database and spike the information
into your in-house database so that you can
compare your, use your data as the background
with all of the cases in the public database.
So, you would take the cases, identify the
cases and then spike them into your internal
database and I can explain some more about
what I mean and how they've done that in the
past.
Next question is: Do you have to pay to get
into the public domain databases?
If you're going to use them in Empirica Signals,
it comes as a subscription for that quarterly
data and if you're interested, then, our,
actually I can move on to that other slide
at the end here that shows the people that
you can contact for additional information.
How do we know that there's no duplicated
data?
Oh, okay. So, part of the cleaning process
that is done by Oracle and provide that information,
they provide the information back to FDA is
cleaning the data. So, they flag for duplicates,
they harmonize the product name. So, say you
might have Bayer aspirin that are 25mg and
just aspirin but they're all the same product,
so they would harmonize those names and they
provide that cleaning back to FDA and then
that's made available as a public subscription.
great, thank you. So those are the only questions
that were submitted at this time. So, if you
have more questions, we'll give you another
minute or so to ask them. We would be happy
to provide you with an answer within next
few minutes. So, let's give it some time.
And, let me just back up on one slide while
we wait. These are some references that Chris
spoke about in the presentation and you can
visit these sources. We have a PDF that we
send you. So, at the moment, I, it doesn't
look like there are any more questions. So,
it's a good time to wrap it up.
So, we would like to thank you so much for
attending this presentation. The webinar was
recorded and will be sent to you within the
next 24 hours. If you have more information
that you would, if you would request more
information from Perficient, you can contact
Chris directly or you can contact our sales
team. You can reach them at lifesciencesinfo@perficient.com
or you can call one of the numbers listed
on the slide.
We have several upcoming webinars. There are
two focused on safety and that has to do with
migrating from Empirica Trace and Oracle AERS
to Argus safety. So, those are the next safety
webinars coming up. And we also have ones
on clinical data management which is focused
on G review and analyzing clinical and safety
data with that software application.
So, since we have two more minutes, I would
like to ask this one question that just came
up. What do you mean by saying three or more
dimensions for drug driven, drug interactions?
There are, it has the capability to look at
more than one dimension for drug/drug interactions
and I can provide that information to you.
I can see who the question came from and I
can provide that in a follow up email with
an example.
Perfect, thank you. So, once again, thank
you so much for joining and we look forward
to having you join future webinars. Thank
you so much. Thank you Chris.
Yep. Thank you so much.
Take care
Bye-bye.
