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DECEMBER 2015
VOLUME 7 • ISSUE 6
GLOBAL
FORUMDRIVING IDEAS TO ACTION
In Memoriam:
Padma Shri Professor
Ranjit Roy Chaudhury, p33
John Reites
Clinical Trials and the
Disney Effect, p11
Special Section on
Media, Communications
& Social Media:
FDA Unveils First Mobile Apps
Medicine Risk Communication
Tools in Europe
Unleashing Social Media in
Drug Safety
...and other related topics!
10 Vol 7 Issue 6 11
GlobalForum|December2015
Special Section
information through a mobile
device, whether it’s a tablet or
a mobile phone. We feel that
pursuing mobile apps is a way
to support FDA’s transparency
initiative by sending out
verified information as
soon as possible and
also to support proactive
communication by reaching
out directly to the people who
want to know this information.
Istas: What can a user do
with the Drug Shortages
app?
Buckman: Users can get the
most up-to-date information
on drug shortages directly
from FDA. The app identifies
current drug shortages,
resolved shortages, and
discontinuations of drug
products. They can search
or browse by drug shortage,
the drug’s name, or active
ingredient. They can also
browse by therapeutic
category and report a
suspected drug shortage or
supply issue to the agency.
We’re still trying to streamline
the app so it’s a little bit
easier for end users to get
information to us.
Istas: And CDER recently
announced the availability of
its second mobile app, the
Orange Book mobile app.
What information does this
app provide?
Buckman: So, the Orange
Book – its proper name being
Approved Drug Products
with Therapeutic Equivalence
Evaluations – is really
information about drugs and
their generics. Our mobile
app is called the Orange Book
Express, and you can use it
to search for prescription,
over-the-counter, and
discontinued drugs all in one
place. Users can search by
active ingredient, application
number, proprietary name,
or the drug product sponsor
(applicant). You can also
access a list of patent and
marketing exclusivities. I feel
that it’s a pretty intuitive app
and people who are interested
in generic drugs and use this
type of data will find the app
to be a pretty handy tool.
References available upon
request.
Today’s consumers expect
seamless, value-driven
experiences when they
engage with a brand. From
buying products online, to
getting text alerts about
doctors’ appointments, to
completing transactions via
mobile apps, they assume
every interaction will be
painless and pleasant – and
participating in a clinical
trial is no exception. People
join these research studies
to improve their health and
contribute data for the care
of others – and in exchange,
they expect their research
experience to be positive,
accommodating of their time,
and intuitive. If it’s not, the
cost-benefit scenario can
shift, and they may decide it’s
not worth the effort.
When planning a trial, most
biopharmaceutical companies
focus on the science. But
when it comes to patient
engagement, the technology
is equally important. And
patients aren’t just comparing
one trial to another. They are
measuring the clinical trial
against every other brand
platform they have ever
encountered. And that’s an
incredibly high bar. Think
about how easy it is to rent
a home on Airbnb, or the
way Target’s Cartwheel app
instantly intuits what users
are shopping for without
demanding any personal
information; or the way
Disney Magic Band gives
visitors instant access to all of
their holiday activities. These
are the touchpoints against
which patients will measure
the clinical trial.
If drug developers want to
attract and retain today’s
patients through the life cycle
of their studies, they need
to create the same seamless
omni-channel experience,
by integrating the best
web, mobile, wearables, and
physical interactions to share
information and keep patients
informed. Unfortunately, the
biopharmaceutical industry
has been slow to jump on
the omni-channel customer
engagement bandwagon,
and it is affecting the success
of their trials. Studies show
attrition rates in phase 3
can be more than 30%, and
while not all of that can be
attributed to clunky interfaces
and disconnected technology,
these drive dissatisfaction
among patient populations.
Every time a patient is asked
to re-enter the same data
multiple times, to transfer
information from one site to
another, or to wait weeks or
months to receive feedback
about their trial, their
frustration increases and
they are at a higher risk of
dropping out – which adds
time, cost, and inefficiencies
to that trial.
THE BEST OF
EVERYTHING
To eliminate friction in the
patient engagement process,
drug developers need to start
thinking more strategically
about the technology
platforms they use to connect
with their patient populations
and build the trial brand. It is
critical that the technology
empower the patient
CLINICAL TRIALS AND
THE DISNEY EFFECT
John Reites
Head of Digital Health
Acceleration, Quintiles
UPCOMING RELATED
OFFERING
Marketing Pharmaceuticals
2016
12 Vol 7 Issue 6 13
GlobalForum|December2015
Special Section
and researchers’ positive
experience with minimal
interruption, that it works
correctly every time, and that
it is effortless to use.
Few clinical trials have
achieved this level of
excellence today. While
technology in our industry has
rapidly evolved and improved
in support of direct-to-patient
approaches, developers
often take a myopic single-
point approach to building
out their technology based
solutions. They may invest
a lot of time and resources
into building one great app,
or implementing a state-of-
the-art wearable device, but
if they don’t think about how
these individual best of breed
technologies integrate into
the broader platform, the
benefit of that tool or device
is lost when it fails to support
a seamless multi-point user
experience.
They also make the mistake
of trying to incorporate every
detail into every channel –
anyone who has ever tried
to fill out a form on their
mobile device knows the
failing of this approach.
Instead, designers should
take advantage of the best
practices of each – i.e., using
text to alert patients to
upcoming appointments,
hosting forms on a secure
website, offering live chat
with a trusted expert via the
web or mobile, and enabling
access to videos and other
quick content via an app.
To ensure patients get these
data in the formats and
channels they most prefer,
developers need to develop
a technology implementation
and integration plan
that combines all of the
optimal tools into one
environment. From an
experiential perspective,
this platform should be to
provide stakeholders with an
experience that is intuitive,
user-friendly, and beautifully
designed to be successful.
From a tactical perspective,
it must be totally secure,
and able to collect and
disseminate data quickly and
efficiently.
USER FEEDBACK BUILDS
BUY-IN
To best meet patient needs,
planners gather feedback
from their target patient
population on what they want
from the platform, and what
would make them feel more
engaged with the experience.
Empowering patients to
influence development of the
trial user interface is at the
forefront of innovative clinical
trial design. This engagement
enables patients to be key
stakeholders in the IT platform
development process and to
influence the design of the
tools they will ultimately use,
which ensures the platform is
user-centric, and secures their
buy-in and loyalty from the
outset.
Quintiles routinely reaches
out to its 3.1 million global
patient community members
and the “digital universe”
across multiple platforms
to conduct assessments
of patient perspectives,
including how they want to
connect with trial operators,
their favorite content
format (i.e., video, data,
audio), and their preferred
method of engagement
(i.e., text, phone, email, or
face-to-face meetings).
Using innovative technology
platforms and engaging
with patient communities
such as MediGuard.org and
ClinicalResearch.com, these
assessments have yielded
important findings that
have helped us adapt the
study design and interaction
experience to make it easier
and more engaging.
Integrating all of these
engagement channels is a
complex and time consuming
project, especially in the
health care field where data
security must be infallible, but
data sharing across channels
is expected to be immediate
and transparent. But it has
to be done. Demand for a
higher level of customer
service through an integrated
omni-channel patient
experience is only going to
increase. If biopharmaceutical
companies want to attract
and retain patients to their
trials, they have to respond
to this demand with a more
sophisticated user platform
that provides patients with
the same quality customer
experience they receive
in every other consumer
transaction. Those who take
these steps today will benefit
from improved retention,
more streamlined data
collection, and lower rates of
attrition – all of which adds up
to happier patients, and more
efficient and successful trials.
About the Author
John Reites, Head of Digital
Health Acceleration at
Quintiles, is a speaker and
author of various conference
presentations, industry
articles and peer-reviewed
publications, providing
subject matter expertise for
direct-to-patient research
patient recruitment, patient
communities, direct-to-
patient observational research
and digital health approaches.
John has more than 12 years
global research experience
with more than 150 programs
spanning phase 1-4 studies
and Commercial programs.
John provided oversight and
development support for
Quintiles patient communities
including MediGuard.org and
ClinicalResearch.com.

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Clinical Trials and the Disney Effect

  • 1. DECEMBER 2015 VOLUME 7 • ISSUE 6 GLOBAL FORUMDRIVING IDEAS TO ACTION In Memoriam: Padma Shri Professor Ranjit Roy Chaudhury, p33 John Reites Clinical Trials and the Disney Effect, p11 Special Section on Media, Communications & Social Media: FDA Unveils First Mobile Apps Medicine Risk Communication Tools in Europe Unleashing Social Media in Drug Safety ...and other related topics!
  • 2. 10 Vol 7 Issue 6 11 GlobalForum|December2015 Special Section information through a mobile device, whether it’s a tablet or a mobile phone. We feel that pursuing mobile apps is a way to support FDA’s transparency initiative by sending out verified information as soon as possible and also to support proactive communication by reaching out directly to the people who want to know this information. Istas: What can a user do with the Drug Shortages app? Buckman: Users can get the most up-to-date information on drug shortages directly from FDA. The app identifies current drug shortages, resolved shortages, and discontinuations of drug products. They can search or browse by drug shortage, the drug’s name, or active ingredient. They can also browse by therapeutic category and report a suspected drug shortage or supply issue to the agency. We’re still trying to streamline the app so it’s a little bit easier for end users to get information to us. Istas: And CDER recently announced the availability of its second mobile app, the Orange Book mobile app. What information does this app provide? Buckman: So, the Orange Book – its proper name being Approved Drug Products with Therapeutic Equivalence Evaluations – is really information about drugs and their generics. Our mobile app is called the Orange Book Express, and you can use it to search for prescription, over-the-counter, and discontinued drugs all in one place. Users can search by active ingredient, application number, proprietary name, or the drug product sponsor (applicant). You can also access a list of patent and marketing exclusivities. I feel that it’s a pretty intuitive app and people who are interested in generic drugs and use this type of data will find the app to be a pretty handy tool. References available upon request. Today’s consumers expect seamless, value-driven experiences when they engage with a brand. From buying products online, to getting text alerts about doctors’ appointments, to completing transactions via mobile apps, they assume every interaction will be painless and pleasant – and participating in a clinical trial is no exception. People join these research studies to improve their health and contribute data for the care of others – and in exchange, they expect their research experience to be positive, accommodating of their time, and intuitive. If it’s not, the cost-benefit scenario can shift, and they may decide it’s not worth the effort. When planning a trial, most biopharmaceutical companies focus on the science. But when it comes to patient engagement, the technology is equally important. And patients aren’t just comparing one trial to another. They are measuring the clinical trial against every other brand platform they have ever encountered. And that’s an incredibly high bar. Think about how easy it is to rent a home on Airbnb, or the way Target’s Cartwheel app instantly intuits what users are shopping for without demanding any personal information; or the way Disney Magic Band gives visitors instant access to all of their holiday activities. These are the touchpoints against which patients will measure the clinical trial. If drug developers want to attract and retain today’s patients through the life cycle of their studies, they need to create the same seamless omni-channel experience, by integrating the best web, mobile, wearables, and physical interactions to share information and keep patients informed. Unfortunately, the biopharmaceutical industry has been slow to jump on the omni-channel customer engagement bandwagon, and it is affecting the success of their trials. Studies show attrition rates in phase 3 can be more than 30%, and while not all of that can be attributed to clunky interfaces and disconnected technology, these drive dissatisfaction among patient populations. Every time a patient is asked to re-enter the same data multiple times, to transfer information from one site to another, or to wait weeks or months to receive feedback about their trial, their frustration increases and they are at a higher risk of dropping out – which adds time, cost, and inefficiencies to that trial. THE BEST OF EVERYTHING To eliminate friction in the patient engagement process, drug developers need to start thinking more strategically about the technology platforms they use to connect with their patient populations and build the trial brand. It is critical that the technology empower the patient CLINICAL TRIALS AND THE DISNEY EFFECT John Reites Head of Digital Health Acceleration, Quintiles UPCOMING RELATED OFFERING Marketing Pharmaceuticals 2016
  • 3. 12 Vol 7 Issue 6 13 GlobalForum|December2015 Special Section and researchers’ positive experience with minimal interruption, that it works correctly every time, and that it is effortless to use. Few clinical trials have achieved this level of excellence today. While technology in our industry has rapidly evolved and improved in support of direct-to-patient approaches, developers often take a myopic single- point approach to building out their technology based solutions. They may invest a lot of time and resources into building one great app, or implementing a state-of- the-art wearable device, but if they don’t think about how these individual best of breed technologies integrate into the broader platform, the benefit of that tool or device is lost when it fails to support a seamless multi-point user experience. They also make the mistake of trying to incorporate every detail into every channel – anyone who has ever tried to fill out a form on their mobile device knows the failing of this approach. Instead, designers should take advantage of the best practices of each – i.e., using text to alert patients to upcoming appointments, hosting forms on a secure website, offering live chat with a trusted expert via the web or mobile, and enabling access to videos and other quick content via an app. To ensure patients get these data in the formats and channels they most prefer, developers need to develop a technology implementation and integration plan that combines all of the optimal tools into one environment. From an experiential perspective, this platform should be to provide stakeholders with an experience that is intuitive, user-friendly, and beautifully designed to be successful. From a tactical perspective, it must be totally secure, and able to collect and disseminate data quickly and efficiently. USER FEEDBACK BUILDS BUY-IN To best meet patient needs, planners gather feedback from their target patient population on what they want from the platform, and what would make them feel more engaged with the experience. Empowering patients to influence development of the trial user interface is at the forefront of innovative clinical trial design. This engagement enables patients to be key stakeholders in the IT platform development process and to influence the design of the tools they will ultimately use, which ensures the platform is user-centric, and secures their buy-in and loyalty from the outset. Quintiles routinely reaches out to its 3.1 million global patient community members and the “digital universe” across multiple platforms to conduct assessments of patient perspectives, including how they want to connect with trial operators, their favorite content format (i.e., video, data, audio), and their preferred method of engagement (i.e., text, phone, email, or face-to-face meetings). Using innovative technology platforms and engaging with patient communities such as MediGuard.org and ClinicalResearch.com, these assessments have yielded important findings that have helped us adapt the study design and interaction experience to make it easier and more engaging. Integrating all of these engagement channels is a complex and time consuming project, especially in the health care field where data security must be infallible, but data sharing across channels is expected to be immediate and transparent. But it has to be done. Demand for a higher level of customer service through an integrated omni-channel patient experience is only going to increase. If biopharmaceutical companies want to attract and retain patients to their trials, they have to respond to this demand with a more sophisticated user platform that provides patients with the same quality customer experience they receive in every other consumer transaction. Those who take these steps today will benefit from improved retention, more streamlined data collection, and lower rates of attrition – all of which adds up to happier patients, and more efficient and successful trials. About the Author John Reites, Head of Digital Health Acceleration at Quintiles, is a speaker and author of various conference presentations, industry articles and peer-reviewed publications, providing subject matter expertise for direct-to-patient research patient recruitment, patient communities, direct-to- patient observational research and digital health approaches. John has more than 12 years global research experience with more than 150 programs spanning phase 1-4 studies and Commercial programs. John provided oversight and development support for Quintiles patient communities including MediGuard.org and ClinicalResearch.com.