The Journal of mHealth Vol 3 Issue 1 (Feb/Mar 2016) | Page 37

The Era of Mobile Data Capture in Clinical Trials
has to be based on a balance between
continuity of care and speed of access.
What does that mean?
70% of the time when a patient consults a GP they want speed of access and
resolution, while only 30% of the time
actually speaking to their GP is critical.

The lesson here is to understand the difference between designing systems that
manage continuity of care for significant
episodes of care and providing simple
speedy access to a clinician when continuity is not important. How clinical services manage this is critical to the patients
perception of efficiency and quality.

So this journey is not going to be easy
- we have two groups who are not easily joined in the middle. Clinicians have
systems that they have developed and
that they like and the new 21st century
patient wants to have their cake and eat it
when it comes to the new model of care
in the 21st century - the fun awaits! n

The Era of Mobile Data Capture in
Clinical Trials
By Tim Davis, CEO, Exco
InTouch
Electronic data collection
has grown rapidly over
the course of the last
ten years and has already
emerged as a common
asset in clinical research
for the completion of
Clinical Outcome Assessments (COA), including
the outcomes captured
directly from patients,
known as patient reported outcomes (PRO). The global growth
of mobile technology over recent years has provided a new and
efficient method of accessing patients, creating an ideal platform for capturing eCOA assessments.
At its core, mobile technology is able to support the diaries,
scales and questionnaires required for capture of PROs during
trials, however the advantage mobile ePRO holds over paper
and other types of ePRO devices lies in the provision of a
simple intuitive interface for patients, that facilitates the 2-way
communication so important to keeping patients engaged
including educational and motivational content delivered via
messaging and in-app notifications throughout their participation in a clinical trial.
The use of mobile ePRO is now becoming commonplace, and
the barriers to adoption have been broken down through the
incorporation of data security measures to protect patient data,
the validation of a huge range of instruments from paper entry
to mobile, and the reassurance of regulatory acceptability – both
through public statements such as comment last year from the
FDA that the “BYOD (bring your own device) approach does
not contravene 21 CFR Part 11”1 and, perhaps more substantially, the use of mobile ePRO to collect primary outcomes data
in numerous product approvals in Europe and the USA.
The move away from ePRO device provisioning and towards a
BYOD approach (where patients use their own mobile devices)
is currently a topic of hot debate. For me, part of the cause of
this debate is the mistaken belief that when introducing BYOD

into a protocol, enrollment of patients with a specific type of
device is the only option. That approach would be offering
choice in the same way that Henry Ford did to the choice of
color for his Model T car – you can bring any device to this
study, as long as it’s an android with Ice Cream version12.2 OS
– this clearly isn’t practical as it would seriously limit study eligibility criteria.
As the only vendor with tangible experience in this field, the
reality of BYOD in clinical trials is very different. We have
been providing ePRO solutions for BYOD trials for many
years and almost always introduce an element of provisioning
in pre-approval studies. The key is to be able to identify the
specifications of the patient’s device and ascertain whether it
meets the requirements for the individual study, if not then a
suitable device can be provisioned. I like to think of it being a
flexible or ‘choice driven’ approach. The provisioning rate for
such studies is decreasing year-on-year as the uptake of more
advanced mobile technology increases (did you know in the US
almost ¾ of adults over 65 now own a mobile phone?2) and
in pre-approval studies we see rates anywhere from about 50%
provisioned down to as low as 10%, depending on the study
population. This provides 2 significant benefits, not only does it
enable the patient to use their own device, the one they selected
from all available options, but it significantly reduces the cost
and logistical complexity of device provisioning for sponsors.
I set out 10 years ago to simplify the process of collecting
patient data during c Ɩ