Decentralized trials white paper by Andaman7

WhitePaper
Virtual vs traditional
clinical trials:
Which do patients prefer?

2
White Paper Andaman7
Virtual vs traditional clinical trials
01 -
Only half of all clinical trials succeed in recruiting
the hoped-for number of participants. Recruitment
issues (unmet inclusion criteria, attrition rate, etc.)
continue to be the primary reason why clinical trials
end prematurely.
02 -
Mobile clinical trials (also called decentralized or
virtual clinical trials) offer many medical, scientific,
economic, and logistical advantages compared to
traditional clinical trials.
03 -
In a study by the CTTI, the majority of respondents
(76%) said they would rather participate in a mobile
clinical trial than a traditional trial.
Key points

3
Introduction
Clinical trials, heralds of
medical progress
In today’s world, no one would think of offering or using a new medication that has not been rigorously
tested in humans. Clinical trials are both a legal requirement and a moral obligation. They are a vital
and critical step between lab research and the launch of an innovative treatment. The goal of a clinical
trial is to test the benefits and potential side effects of a drug or a diagnostic, screening, or prevention
method, all the while «respecting the highest possible standards of safety, quality, and ethics» (1)
. Clinical
trials not only contribute to innovation in healthcare, but also allow patients to benefit from new
medications free of charge before these drugs become available on the market. They also provide
patients with access to innovative therapies for diseases with no proven treatments.

4
Mounting challenges
The success of a clinical trial depends on its ability to recruit and enroll, and then collect data from
participants. Today, these requirements are becoming harder and harder to meet, in particular (but
not only) when it comes to treatments targeting extremely specific diseases that only affect a
small percentage of the population. There are many reasons for this. Nevertheless, according to a
study published by the Center for Information and Study on Clinical Research Participation (CISCRP),
80% of all clinical trials conducted in the United States in 2017 were delayed due to recruitment
issues (2)
. In fact, only half of all clinical trials succeed in recruiting the hoped-for number of
participants. Recruitment issues are also the main reason why trials end prematurely (3)
. These
obstacles to clinical trials are not without consequences. They significantly increase the cost
of clinical research, delay the adoption of new types of treatments, result in a loss of profits
for pharmaceutical companies, and reduce a patient’s chance of being cured or improving their
wellbeing.
The rise of decentralized
clinical trials
When it comes to clinical research, centralized (hospital-based) trials are still the most popular.
But the widespread use of mobile technologies (tablets, smartphones), connected objects (smart
watches and scales, blood pressure monitors), and innovative healthcare applications are now

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shifting the balance. Technology not only makes it possible to collect enormous amounts of data,
but also to organize fully digital and decentralized pharmaceutical trials known as «virtual clinical
trials» (VCTs).
In fact, mobile technologies are revolutionizing the way we think about
clinical research. They boast a number of advantages compared to the
traditional clinical approach, including:
01 -
Improved and expanded data collection
Large amounts of data, some of which had previously not been
made available by traditional clinical research, can now be measured,
monitored, and entered remotely by doctors, researchers, and even
patients themselves - in real-time. In particular, this data collection
allows for electronic patient-reported outcomes (ePROs) to be
used as evaluation parameters to better reflect the results that are
important to patients. Take the ACR score, for example, the main
evaluation criterion for patients with rheumatoid arthritis. Rob Scott,
M.D., Chief Medical Officer at AbbVie (4)
, explains: «Unfortunately, this
score doesn’t mean much to patients. They experience more satisfaction in
their daily lives by being able to tie their shoes or wake up and get going in
the morning. These two things can be measured digitally without any real
effort from the doctor or the patient, and can subsequently be taken into
account during clinical trials.»

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02 -
Simplified recruitment, direct access to patients
Recruitment issues are the main reason why clinical trials end
prematurely. Potential participants may live too far away from
research centres, lack access to information, come from different
cultures, or have difficulty travelling due to their health condition or
disability. On the other hand, mobile and connected devices, which
are now in widespread use among the population, facilitate access
to information and do not restrict participation in a clinical trial to a
specific geographic location. As a result, they enable larger numbers
of patients to participate in clinical trials (3)
.
03 -
Increased patient engagement
Many mobile health (mHealth) tools are extremely user-friendly.
What’s more, smartphones, connected devices, and mobile health
applications are now staples in the everyday lives of most patients (5)
.
These tools allow patients to participate in a trial more informally and
at their own convenience. They also let patients play an active role in
clinical research and make it easier for researchers to take a patient-
centred («patient-centric») approach, in particular by working directly
with patients to define the targets, tools, and protocols of a clinical
trial and obtain their evaluations and feedback (6)
.

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04 -
Innovative research
The increasing use of mobile health technologies (and the data
they generate) bodes well for advancements in medicine. New
technologies will make it possible to personalize, improve, and
monitor the effectiveness of treatments, as well as help develop new
medical products and solutions. This is especially true for countries
that currently lack optimal medical treatments.
05 -
Benefits for pharmaceutical companies
For the drug industry, the use of new technologies can help increase
profits, especially in light of the fact that R&D performance has fallen
to its lowest level in nine years (7)
. As pointed out by researchers
at Inserm (4)
, «drug companies can take advantage of quick trials with
large numbers of patients to quickly develop products and benefit from
longer periods of time without competition from generic drug producers.»
According to these researchers, the speed at which trials can be
completed with mobile technologies plays a major role. Mobile
technologies facilitate the recruitment process, maximize patient
retention, and allow for the quick and easy creation of applications for
financial assistance. For some drugs, twelve weeks on the market is
equal to a profit of 800 million dollars!

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Growing interest for mobile technologies
in healthcare
Mobile health (mHealth) has often been heralded as the field of the future. But the revolution
seems to have already begun! As numerous polls, studies, and surveys have shown, mobile health
technologies are now being used by more and more consumers, healthcare professionals, and
patients. The figures are quite convincing. There are more than 318,000 mobile health applications
in the app stores around the world, some of which of course are better than others. What’s more,
200 new apps are added every day. By 2025, the value of the mobile health app market is expected to
reach 111.1 billion dollars. Some studies have found that 75% of U.S. consumers believe technology
is important for managing their health. At the same time, participants said they were willing to try
smart devices if such devices could help them manage their health. Moreover, 74% of the people
who had already used virtual healthcare services were satisfied with the experience (8)
. Finally, a
study of 2,000 patients found that 47% of them already use mobile health applications to monitor
their health status, while 87% use these apps at least once a week.
Some barriers remain...
Previous studies have suggested that the age
of the user is an important factor when it comes
to the adoption of mobile health solutions. In
the past, older users were often reluctant to use
these tools because they lacked the necessary
technical know-how. But more recent surveys
suggest that this situation is changing.
Compared to younger generations, people aged
65 and older tend to use mobile technologies
much less frequently. However, smartphone
use among the elderly jumped from 18% in 2013
to 42% in 2017. A survey conducted by Welltok
found that 80% of elderly patients already use
mobile health applications. And over half (56%)
of these patients said they would even be
willing to use them as part of their treatment (5)
.

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We’re seeing more and more evidence that
interest in mobile health solutions is no longer
based on the age of the user.
Othersociodemographicfactors,includingtech-
savviness, annual household income, and level
of education have also been found to determine
whether or not users are likely to adopt mobile
technologies. But this finding could also be
misleading. In 2018, Deloitte conducted a
survey of U.S. healthcare consumers. It found
that most adult Medicaid recipients not only
own mobile technologies, but also use them
for a variety of health-related purposes and
are interested in trying out new digital health
applications in the future (9)
.

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Wemightbequicktoconcludethatmobilehealth
solutions are now becoming the norm. But
accordingtoanotherstudybyDeloitte,conducted
in 2016, the use of mobile technologies is not
always a priority. This study found that patients
often prefer factors such as patient-doctor
interaction to online appointment scheduling,
patient-generated health data, telehealth,
and online health resources. These results are
surprising given the role that technology now
plays in our daily lives. Why do mobile services
sometimes take a back seat? «One explanation,
which was confirmed in our focus group, is that
many people are unaware of mhealth and its digital
tools,» concludes Deloitte. In order to bridge this
gap, the prominent auditing firm suggests that
providers should focus on what patients want
and need (10)
.
Remote clinical trials
as seen by patients
The same thing seems to apply to mobile clinical trials. As we have seen, the use of mobile
technologies in clinical trials provides for numerous scientific, medical, economic, and logistical
advantages. However, as advantageous as smart devices may be, their use is largely dependent
upon the preferences of patients. We still have much to learn in this regard. The key question
for trial sponsors and other organizations is how to maximize the potential of these mobile tools
in accordance with the preferences of potential participants and patients. An encouraging initial
study was sponsored by the Clinical Trials Transformation Initiative (CTTI) and published in the
journal Contemporary Clinical Trials Communications (11)
.
It involved 193 potential clinical research participants between 23 and 83 years of age. The purpose
of the study was to determine how patients viewed mobile tools and their willingness to participate

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in mobile clinical trials. It was conducted by way of an online survey describing hypothetical mobile
and traditional clinical trials. The study examined how patients felt about each method, as well
as their desire to participate in the two types of trials. It also identified their preferred mobile
test procedures and the mobile technologies they were most willing to use. Participants indicated
their preferences with regard to the frequency of clinic visits during trials, device training and
troubleshooting, data privacy, data storage locations, and access to the data collected by the tool
in question.
Finding: patients prefer mobile trials
The study participants wholeheartedly welco-
med the idea of taking part in a decentralized
clinical trial. A large majority (76%) specified
that given the opportunity, they would rather
participate in a mobile trial than a traditional
trial based on standard clinical evaluations. This
preference was backed by the convenience of
mobile tools and the time that would be saved
by making fewer trips to the clinic. Wireless
tools were also seen as having the potential to
provide for greater accuracy in terms of data
collection. However, the authors of the study
did notice that on-site visits were one of the
main reasons why some participants preferred
traditional trials to mobile ones.

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Privacy - a relatively minor concern
One of the biggest worries was that the
participants would be reluctant to share their
health data via wireless devices. But it turns
out the opposite was true! The survey results
suggest that patients would worry little about
privacy and confidentiality when participating
in trials involving mobile technologies. Although
there were few concerns related to data storage,
some participants indicated a slight preference
for data to be stored locally (on the device) or
on the data servers used for the trials instead of
by the manufacturer of the technology. On the
other hand, participants who were concerned
about the security of their data were less likely to
participate in a mobile clinical trial.
These results differ slightly from the findings of
previous studies. A study from 2017 suggests
that while patients are willing to share their
medical data, they also seem to be extremely
concerned about issues related to privacy,
transparency, security, and the ability to decide
who can access their data and for what purpose.
As the authors of this study (12)
point out,
«studies have shown that patients are more likely
to entrust their medical information to healthcare
professionals than share it with government
agencies, insurance companies, or researchers.»

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Access to data by participants
What about the ability of participants to access
the data that is collected for a mobile clinical
trial? There are fewer surprises here. Nearly
all participants (80%) expressed a wish to have
access to their data on a weekly or even daily
basis.Accordingtotheresearchers,thisishardly
surprising given the fact that access to personal
data is now commonplace among consumers
accustomed to using mobile devices and
technologies. It is therefore important to offer
accesstodata,buthow?Accordingtotheresults
of the study, the device itself or a personalized
web page would be the two preferred means.
However, the researchers did not ask specific
questions about the type of information the
patients wished to obtain. It should also be
noted that most of the participants indicated
that they use a smartphone (87%) or a tablet
(50%) on a daily basis. Furthermore, 2/3 of these
users reported using a mobile app to monitor
their health, with the vast majority saying they
were «comfortable» or «very comfortable»
with these types of applications. At the same
time, the participants were found to have used
smart health devices less frequently in the year
leading up to the study. But a large majority of
those who used them felt «comfortable» or
«very comfortable» with such devices.
Preferred devices
Another goal of the study was to determine
which interfaces were most appealing to the
participants. Five types of technology were
tested. For nearly all the participants (90 to 95%),
motion sensors, smart watches and patches, and
applications for tablets and smartphones were
at the top of the list. These devices were closely
followed by smart body fluid analysis devices
(blood, saliva, urine) and ingestible sensors. Not
only did mobile devices and applications appeal
to the majority of the study participants, but
many of the participants also said they would
be willing to use the devices on a daily basis for
a year or more, or for as long as the trial lasted.
These figures range from 64% to 83%, depending
on the technology.

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Personal or borrowed device?
The participants were asked another question.
What would they do if they had a health device
that was comparable to the one used in the
mobile clinical trial? More than half said they
would rather use the technology provided by
the study than their own device. However, 1/3
of the participants did not express a preference.
At the same time, most participants (86%)
considered not having to pay a fee while using
theirowndevicetotransmitdataas«somewhat
important.»
Some thoughts
As the authors point out, their study is simply
a springboard for understanding how potential
participants view mobile clinical trials. While
encouraging, its results have yet to be
confirmed by other studies. «More research
and the sharing of practical experience is
required to ensure mobile technologies are
used effectively in clinical trials,» the authors
explain. The authors also draw attention to
some future developments related to the use
of wireless technologies for research purposes.
The more results (endpoints) that are collected,
the more sponsors will have to focus on
measuring patient reactions to the changes
that mobile tools bring about in clinical trials.
According to the authors, researchers will be
required (among other things) to weigh the
pros and cons of having patients come into the
clinic and providing the wireless solutions that
are necessary for the trials. Other important
issues must also be addressed by future
studies, such as gaining a better understanding
of how certain remote and diverse patient
populations with limited access to technology
might perceive the benefits of participating in
mobile clinical trials.

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Our platform
Andaman7, quick and easy
clinical trials
Createdin2014toallowpatientstoconsolidatetheirmedicalrecordsonanymobiledevice,Andaman7
is a digital, multi-pathology health platform that offers solutions for the entire healthcare industry,
including research institutions, pharmaceutical companies, medical device designers, hospitals,
doctors, laboratories, patient associations, and healthcare professionals. It is the first comprehensive
mobile PHR (personal health record) that is both patient-centric and designed for research.
Free (for patients) and incredibly easy to use, this mobile app creates personal health records by
collecting medical data on patients and their conditions. It collects all kinds of documents and

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data, including information from doctors, hospitals, patients, and even other connected devices.
Andaman7 is made unique by its secure peer-to-peer system that allows users to share their medical
information with their inner circle (family, friends, doctors, hospitals, etc.). The system stores all data
locally (no Cloud) and fully respects the guidelines of the GDPR. There is consequently no risk of
personal data being processed without the explicit consent of the user. Privacy is also respected in
that only patients can decide what is done with their health data.
Andaman7 today: 20,000+ registered users, 20 different languages,
12 full-time employees, and a technological investment equivalent to
more than 30 person-years.
A secure medical data sharing platform
One of the most exciting characteristics of
Andaman7 is that it not only meets the needs
of patients, but of all those involved in the
healthcare industry. For example, the app
provides solutions to current problems faced
by medtech and pharmaceutical companies,
such as the rising cost of research, stricter
pay-for-performance requirements, regulatory
burdens, and difficulties recruiting and enrolling
patients for clinical studies and collecting data
about them. Built as a secure medical data-
sharing platform and benefiting from simplified
eConsent, Andaman7 allows for effective
interaction between patients and healthcare
professionals (hospitals, doctors, researchers,
etc.). It shares all kinds of data with the utmost
in security, traceability, and interoperability:
connected devices, ePRO questionnaires,
photos, lab results or genetic tests, data from
hospitals, etc. An integrated solution, the
Andaman7 platform can be used at every stage
in the development of a drug or healthcare
device.

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Use case
Quality-of-life study for
Janssen France
Description
Andaman7 developed a solution for Janssen Cilag France to facilitate the data collection process for
patients and researchers during a study on quality of life. In general, clinical studies on quality of life
are rarely convincing. The questionnaires are usually long and difficult for patients to complete. For
example, if a patient is asked how many migraines they had in the past three months, it is unlikely
that they will remember and be able to provide precise information.

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There are two problems with this kind of study: first, the poor quality of the collected data, and second,
the large number of patients who drop out along the way. Quality-of-life studies must be conducted
over long periods of time to be effective. What’s more, their questionnaires are usually submitted in
paper form, which makes the task even more difficult for patients and requires expensive data entry
that comes with an increased risk of error.
The challenge
Andaman7 was tasked with simplifying the collection process for patients to reduce the dropout rate,
all the while improving the quality of the collected data.
Our solution
Andaman7 is a comprehensive and easy-to-use mobile health record application. Thanks to the
Internet of Things (IoT), Andaman7 can be linked to a variety of smart devices (glucometer, blood
pressure monitor, etc.). These devices can be used to collect data on physical activity, sleep, and
many other factors that can be measured automatically. This reduces the number of questions for
the patient as well as the rate of dropout.
Andaman7 is a PHR (personal health record) that patients can complete at their own convenience on
their smartphone.
We also offer patients a widget for their tablet or smartphone so they can enter data without having
to open the app. This allows for certain information (e.g. regarding the onset of pain) to be recorded
even faster. The information is saved in just a few clicks.

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Sources
(1) Clinical trials in cancer surgery and other interventional techniques: radiology and endoscopy. Analyzing
the rights and safety of patients. January 2016.
www.ligue-cancer.net
(2) Sanofi is launching «digital» clinical trials to improve patient recruitment and speed up the research
process.
www.sanofi.com/fr
(3) EISINGER F., HIRSCH F., BAERTSCHI B., BOTBOL M., JOUET I., LAPOINTE A-S., CHNEIWEISS H., Clinical
research: reaching potential participants. Getting a head start to ensure optimal inclusion. March 2019.
www.hal.inserm.fr
(4) Clinical trials in a connected world.
www.abbvie.fr
(5) HEATH S., How mHealth Technology Supports Patient Engagement Strategies.
https://patientengagementhit.com
(6) LOPRESTI M., APPELBOOM G., BRUYERE O., REGINSTER J-Y., KLUG E., CONNOLLY E.S.JR., Patient
engagement in clinical research through mobile technology. Future Medecine Ltd, 2014.
www.openaccessjournals.com
(7) Embracing the future of work to unlock R&D productivity.
www2.deloitte.com/uk
(8) GEORGIU M., How Mobile Apps are Transforming the Healthcare Industry.
www.imaginovation.net
(9) MAJEROL M., CAROLL W., Medicaid and digital health findings from the Deloitte 2018 Survey of US
Health Care Consumers.
https://www2.deloitte.com/us
(10) HEATH S., Patient-Provider Interaction Top Priority for Health Consumers
https://patientengagementhit.com
(11) PERRY B., GEOGHEGANC C., LINB L., MCGUIREA F. H., NIDOE V., GRABERT B., MORING S.L., HALLINANA
Z. P., CORNELIA A., Patient preferences for using mobile technologies in clinical trials.
www.sciencedirect.com
(12) ESMAEILZADEH P., SAMBASIVAN M., Patients’ support for health information exchange: a literature
review and classification of key factors.
https://bmcmedinformdecismak.biomedcentral.com

E U H E A D Q U A R T E R S
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CA 94061, USA
T. +1 (518) 320-2613
E M A I L
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W E B
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