The Technology Headlines DEMAND FORCASTING & AI | Page 20

OPINION
&
INSIGHTS
THE TECHNOLOGY HEADLINES
DEALING WITH TECHNOLOGY CHANGE
.........................................................................................................................
By Cathy Dawson, Director of Clinical Affairs, Aesculap
.........................................................................................................................
B
usinesses in pursuit of new technologies generally
perform better in the market. Today, established
players are able to make steady progress by utilizing
new technology platforms. However, it shouldn’t stop there!
Organizations need to figure out ways to apply these derived
insights to create value as demanded by customers. See for
instance in the clinical world, technology is driving new
opportunities to impact patient retention, endpoint collection,
and timelier reporting of safety and efficacy signals.
In a world driven by metrics, how do you measure the impact
of a technology upon a trial? Considerations include:
- Customer experience (defined as the site and patient)?
- Process management effort/costs
- Data delivery defined as speed and accuracy
A seemingly straight-forward decision to implement a
technology can complicate operational paradigms for study
team members, increasing both process management costs in
headcount and in actual dollars to implement. Drivers include:
- Multiple outsourcing partners (including subcontractors)
- Confidence and familiarity with technology (think tech
support)
- Applicability & Comfort with quality standards in the new
format
- Density in the web of data transfers.
What to Do?
Let’s start with a simple example.
In indication X, the FDA recommended endpoint is a PRO
(Patient Reported Outcome). Technology expands the toolbox
questionnaire data collection – a specific value within a long
term trial where patient retention is a large concern.
One approach might be
Objective:
Retention
Endpoint:
PRO data
Strategy:
Use multiple validated methods for data
capture
Technology:
Primary data entry (Patient)

-IWRS

Secondary data entry (SC)

-IWRS

- mail/fax

-telephone interview

-paper
AUGUST 2019
Cathy Dawson
Points to Consider:
Viewing through the lens of patient retention, what could
be better than a patient reporting experiential data directly?
You would remove the burden of time and travel to the site;
remove transcription time (and error) on the part of the study
coordinator; and eliminate the monitoring issues as source and
data are reconciled.
But Consider First:
Validated Imaging: Will the electronic image mean the same
as the analog experience? Not always. How will you insure
your data is still appropriate? Who will certify the digital
translation?
Quality of Tech Support: A constant source of frustration
is actually accessing the technology. Server speeds, down
time, dead zones, or even the dreaded lost password can sow
frustration and disenchant users- critical issues if you are also
concerned with patient enrollment.
Robust Processes: In the example above, robust GDP (Good
20