By; Valdo Arnera MD,
PHT
Europe General Manager and Chris Hall,
Senior Marketing Manager, PHT Corporation
The specialized
industry of collecting electronic clinical outcome assessments (eCOAs)
including patient-reported outcomes (PROs) is increasing exponentially. This is
in part because global government regulators want to hear directly from the
patient, and because electronic collection (versus paper collection) improves
data quality and efficiencies for data analysis and trial management.
The FDA Guidance for
Industry – Patient-Reported Outcome Measures states that ‘The degree of
respondent burden that is tolerable for instruments in clinical trials depends
on the frequency and timing of PRO assessments in a protocol and on patient
cognition, illness severity, or treatment toxicity. For example, if the
questionnaire contains instructions to skip one or more questions based on
response to a previous question, respondents may fail to understand what to do
and make errors in responding or find the assessment too complicated to
complete. Sponsors should consider missing data and the refusal rate as
possible indications of inappropriate respondent burden or inappropriate items
or response options.’ [i]
In other words, the
FDA does not want sponsors to place undue burden on patients. eCOA Systems
minimize respondent burden with features that make even complicated diaries and
questionnaires simple for patient populations of all ages.
Globally, there are
five proven ways to collect COA/PRO data – smartphone, phone, Internet, digital
pen and tablet. The device or combination of devices most suitable depends
entirely on the protocol requirements, including
1)
Where will the COA/PRO data
be collected?
a.
In transit, at the clinic, or both?
2)
Will the COA/PRO data be
collected using simple or complex questionnaires and/or diaries?
a.
Simple means short and brief questions that require dichotomous
responses.
b. Complex means long diaries, many questions, questions using body
graphics, and/or visual analog scales.
3)
Will COA/PRO data be
collected frequently, episodically, or infrequently?
a.
Frequent refers to timed assessments, on a
fixed schedule, daily, or several times a day.
b.
Episodic refers to event-driven data
collection.
The following chart summarizes each of these five collection devices,
recognizing that the ideal method of acquiring patient-reported data are further
determined by each trial’s indication, size, complexity, length, locations,
survey elements, patient population, budget and critical success factors. These devices may be used alone or in a
combination with others, depending upon study protocol requirements.
eCOA Devices
 |
| Click image for larger view |
Advantages &
Disadvantages
eCOA Device
|
Advantages
|
Disadvantages
|
|
1
|
Smartphone electronic data
capture on a mobile browser
|
·
Widely available
·
Easy-to-use
·
Collects frequent
and/or episodic events
·
Enables patient
reminders
·
Options for touch
screen or stylus data entry
·
Enables efficient
mid-study changes
·
Integrates with data
from glucometers, PEF meters and actigraphs
·
Displays visuals and
scales
·
Compares data instantly
on-device for medicine, diary or activity prompts
·
Alerts site of extreme
high or low patient dosages, irregular and infrequent diary entries and/or
compliance issues
·
Alerts monitor of data
out-of-range
|
·
Often provisioned to
ensure availability and universal cognition
|
2
|
IVR (Interactive Voice Response): keypad or voice
data capture
|
·
Widely available
·
Easy-to-use
·
Enables patient
reminders
·
Enables efficient
mid-study changes
|
·
Suitable only for short
and simple diaries
|
3
|
Web Browser
electronic data capture on any device with
Internet access
|
·
Becoming widely
available
·
Accommodates complex
and lengthy diaries and questionnaires
·
Enables efficient
mid-study changes
·
Displays visuals and
scales
·
Enables efficient
mid-study changes
·
Compares data instantly
on-device for medicine, diary or activity prompts
·
Alerts site of extreme
high or low patient dosages, irregular and infrequent diary entries and/or
compliance issues
·
Alerts monitor of data
out-of-range
|
·
Patient reminders
unavailable
|
4
|
Digital Pen
captures data electronically
|
·
Easy-to-use
·
Uses images and visual
scales
|
·
Requires special paper
·
Suitable only for short
and simple diaries
·
Does not provide
real-time data
·
Extensive back-end data
quality checks required
|
5
|
Tablet
electronic data capture on a tablet
|
·
Widely available, easy
to use
·
Enables efficient
mid-study changes
·
Options for touch
screen or stylus data entry
·
Displays visuals and
scales
·
Compares data instantly
on-device for medicine, diary or activity prompts
·
Alerts site of extreme
high or low patient dosages, irregular and infrequent diary entries and/or
compliance issues
·
Alerts monitor of data
out-of-range
|
·
Provisioning is
cost-effective for site use, not individual diaries
|
Conclusion:
Each
of the five types of eCOA devices have been used for successful data submission
to regulatory agencies, and each has specific utility for protocol
requirements. Selecting the best device(s)
for your next trial should be based upon protocol requirements.
Regardless
of which device(s) is (are) used, eCOA devices are proven to collect
attributable, legible, contemporaneous, original, accurate (ALCOA) data; the
standard for evidence that is expected by regulatory authorities for accurate clinical
outcome assessments.
[i]
FDA, Guidance for Industry.
Patient-Reported Outcome Measures: Use in Medical Product Development to
Support Labeling Claims, 2009, http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf
(April 2013).
[ii]
PHT provides a FREE online decision tool to assist with determining the most
suitable device(s) for eCOA/ePRO collection.
Visit http://bit.ly/15XiLcd
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