Problem/Issue
Statement
Problem: oft-cited claim that, for the average prescription
drug, each day of delay in market entry for the product costs the sponsor
roughly $1 million in lost sales.
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P&G , like most other pharmaceutical firms,
had relied upon paper-based methods for collecting this information
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May 2001, six pilot trials using Web-enabled
electronic data capture, a new technology for collecting trial data from
investigator sites
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EDC’s ultimate costs and benefits of this
technology is uncertain
Situation
Assessments
o
Questions:
§
Could the use of a technology like EDC really
add value to the clinical trials process
§
If EDC technology was to adopted, where would
the business value come from
§
How would the process changes brought on by the
use of EDC play out among the relationships within P&G, and between the
company and the investigative sites upon which it relied for the success of its
trials
List of Plausible
Alternative Courses of Action
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Improving the Paper-Based Process
o
Adjustments to the paper based system
§
Use of express mail shipments from the sites on
a daily basis and increased staffing to perform site monitoring and source-data
verification more rapidly
§
Paper-Based Process has its limits
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Digital Imaging
o
Similar system as Paper-Based Process
o
Digitally received and stored by the system
o
Double-entry process, clerks used a split screen
with the document image on one side and the data entry form on the other.
o
Problems:
§
IRIS did little to mitigate the delay and
workload involved in data entry and error checking
§
Transmission of these images to users around the
company was vastly improved
§
Takes quite a bit of memory and capacity
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Web-Enabled EDC
o
Allowed data to be entered into the data
management system directly by the investigative sites
o
Records were immediately available to the
sponsor for the purposes of monitoring the trail and conducting preliminary
analyses on blinded data
o
No Double entry of data was required
o
Identify discrepant records and notify site
investigators of the need to address data or patient issues
Recommendation
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Web Enabled EDC
o
Software did not reside at the investigative
site, thereby reducing the need for sponsor-provided, onsite support
o
Navigation through a Web interface was less
burdensome for the sites than learning the proprietary software used in
PC-based system
o
Internet is something that site investigators
and coordinators were familiar with
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