Mika Lindroos, Director of Product Management at CRF Health, discusses the advantages of electronic informed consent in clinical trials and how by integrating this process with eCOA technologies, researchers can reduce burden for study teams, decrease regulatory risk, increase participant comprehension, and improve overall study outcomes. Courtesy of PharmaFocus (original link: http://edition.pagesuite-professional.co.uk/launch.aspx?eid=b3114258-2357-4dee-b791-295cd1220624&pnum=18)

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patient-reported outcomes
PharmafocusJuly/August 2016
The Role of Informed Consent
Every patient has the right to know
and understand what will happen
during a clinical trial in order to
make an informed and voluntary
decision to participate. The infor-
mation provided to a patient about
a study includes many elements
such as the purpose, the treatment
procedures and schedule, whom to
contactduringthestudy,thelength
of participation, benefits and asso-
ciated risks, and more. This is a lot
of information and patients must
understand their rights as a clin-
ical trial participant. To ensure
this, before any part of a clinical
trial begins, investigators must
obtain the informed consent of
participants.
Although simple in theory, se-
curing consent involves more than
just obtaining a participant’s signa-
ture – an important point reiterated
by recent FDA guidance - sponsors
need to ensure participants truly
understand what they are signing.
A critical first step, failing to obtain
proper consent can have a major
impact on regulatory compliance,
enrollment rates and expenses
across a study’s lifecycle.
Like many processes in clini-
cal research, informed consent has
traditionally been obtained via pa-
per-based methods, that have be-
come very lengthy, with researchers
including extensive legal informa-
tion, rather than providing a concise
and informative way of presenting
study information to a potential
participant. Furthermore, due to the
ever-increasing complexity of to-
day’s clinical trials, gaining consent
via paper-based methods can lead
to poor documentation, data loss,
lack of participant understanding,
reduced compliance and retention
levels, as well as increased study
costs. Recommended alternatives to
ineffective lengthy paper consents
are being debated in the industry
to better support the presentation
of study information and to bet-
ter support the consent process for
development, signing and version
control.
In a time where data acquisition
and capture in clinical research are
becoming increasingly collected via
electronic solutions, common sense
tells us that it is the logical step to
do the same for obtaining informed
consent, as all the advantages of the
electronic modality also apply to
this process.
Why eConsent?
Introduced in recent years and
representing a major advancement
in improving patient comprehen-
sion in clinical research, electron-
ic informed consent (eConsent)
better utilizes learning principles
with electronic systems and pro-
cesses, including text, audio and
video features etc., to communi-
cate study information to patients,
in order to obtain and document
informed consent.
eConsent offers researchers nu-
merous benefits, including the ca-
pability to mitigate regulatory risks
– crucial for all study teams. In-
formed consent is widely-acknowl-
edged as being among the most cit-
ed regulatory breaches, resulting in
citations, delays, litigation and even
trial failure. Through the use of dig-
ital timestamps, consistent version
control, real-time remote monitor-
ing, and ongoing tracking, eConsent
solutions can provide a clear audit
trail. In addition, patients can sub-
mit their signatures electronically or
print and sign a paper version, mak-
ing it easy for study teams to comply
with local regulations.
Another prevalent issue eCon-
sent helps to overcome is patients
What the future holds for informed consent:
The role of hybrid technology in supporting
patient consent in clinical trials
Mika Lindroos, Director of Product Management at CRF Health, discusses the advantages of
electronic informed consent in clinical trials and how by integrating this process with eCOA
technologies, researchers can reduce burden for study teams, decrease regulatory risk, increase
participant comprehension, and improve overall study outcomes.
This is a lot
of information
and patients must
understand their
rights as a clinical
trial participant Image:©Photographee.eu–shutterstock.com

2. 20
patient-reported outcomes
Pharmafocus July/August 2016
consenting to participate in trials
without fully understanding the
study, which can prove very prob-
lematic for supporting study partic-
ipants’ rights to voluntarily consent.
This impacts informed participants
coming onto a trial and thus staying
on a trial, not to mention complying
with the study requirements. Addi-
tionally, this could cause issues relat-
ed to human subject protection and
data integrity. By combining tiered
information delivery, interactive
assessments, rich multi-media and
support for further communication
with study staff, collecting consent
electronically can help researchers
achieve better patient understand-
ing of complex information and
concepts. By enhancing patient un-
derstanding and offering the capa-
bility to verify that they truly com-
prehend consent information, study
teams can streamline enrollment,
improve compliance and engage-
ment, and reduce costly dropouts.
Collecting informed consent elec-
tronically is also more efficient for
sponsor and site study teams. With
paper-based solutions, for a partici-
pant to read an entire document and
ensure that they fully comprehend all
of the information provided usually
requires significant investigator and
study coordinator time during a site
visit. However, the interactive nature
of eConsent makes the informed
consent process not only clearer to
understand, but also more compre-
hensive, helping patients make bet-
ter, more educated decisions. As well
as making obtaining consent more
efficient, considering the significant
amount of investigator and study
coordinator time needed to explain,
complete, QC and collate paper con-
sent forms, the potential time and
costs savings are vast.
In addition to all of the above,
eConsent also allows for remote
monitoring of the process through
real-time dashboards for multi-
ple studies, sites and patients, and
tracks and time-stamps interac-
tions, providing a clear, digital
audit trail. This makes the data
defensible and supports better
documentation for each consent-
ed participant consent experience,
allowing study teams and IRBs/
IECs to monitor the consent status
of all sites and participants. Hav-
ing the data regarding participant’s
informed consent experience can
allow developers of consents to im-
prove the content and even the con-
tent of a protocol by reconstructing
and evaluating where the process
needs improvement. As a result,
this can make the consent more ef-
fective and patient-centric. Finally,
eConsent also ensures version con-
trol and decreases the high error
rates in completion and filing that
are synonymous with paper-based
consent designs.
Integration of eConsent
In integrating an electronic ap-
proach to informed consent with-
in a clinical trial, one of the major
hurdles for sponsors is incorporat-
ing yet another technology system
into their design and all the pro-
cesses and requirements involved
in doing this successfully.
To address this, eConsent solutions
are now being developed which inte-
grate with existing technology, such as
eCOA platforms, that many sponsors
are already using within their clinical
trials. By integrating informed consent
and eCOA solutions on a single plat-
form and on the same device, study
teams can enhance patient understand-
ing,increaseregulatorycomplianceand
reduce quality risks, all while removing
the additional burden on study teams
and patients that would be inherent
with the use of a separate system. This
also provides considerable savings to
researchers by removing the need to
purchase an additional system, as well
as the time and cost associated with in-
tegrationproceduresandtraining.
Conclusion
There is no doubt that the future
of obtaining informed consent in
clinical trials will be via electronic
methods, but there is reason to sug-
gest that the industry should be striv-
ing for a hybrid approach when it
comes to developing and integrating
this advancement.
Integrating eConsent technolo-
gy with existing platforms, such as
eCOA solutions, removes the need for
any additional consenting technolo-
gies to be included in a trial’s design,
significantly reducing the burden and
complexity for site and sponsor study
teams, reducing regulatory risk and
driving better patient comprehension
of a study’s unique requirements.
Mika Lindroos Bio
Mika Lindroos is the Director of Product Management at CRF Health,
and he says he is most at home where technology meets humanity. With
just over two decades in software product management in the global
environment, Mika’s breadth of experience spans from product and
portfolio management, strategy and business development, and head-
ing a product line at Nokia, to revenue and business relationship devel-
opment at Digia Pic. Mika is a specialist in developing and managing re-
lationships both internal and external to his organization, as evidenced
by his varied roles in team motivation, change management, as well as
customer relationship development.
Although simple
in theory, securing consent
involves more than just obtaining
a participant’s signature