Applied Clinical Trials - September 2013 - Supplement - (Page 3)
What Does the Future Hold
for Clinical Monitoring?
Andrew Schafer
Current commercial forces are working to accelerate
the adoption of adaptive monitoring designs.
hen you are through changing, you are
through.” So says Bruce Barton. Bruce
who? Think Betty Crocker. She’s Barton’s
creation. So are the enduring household
reputations of Campbell Soup, Revlon,
General Motors, and General Electric. Barton is
among the most successful advertising executives
in American history—some insist, the best. A real
forward thinker for most of the 20th century.
If Barton were alive today, he would be all
over the results of a recent Industry Standard
Research (ISR) Study* evaluating what clinical
monitoring might look like in 2015.
Why? We know that the biopharma industry is
not what it was five years ago as financial pressures continue to mount. Second, we know that
clinical monitoring can account for approximately
half the costs of later stage clinical development
projects, so if companies are going to cut costs,
they might as well target the biggest bucket.
That being said, survey results reinforced that
traditional clinical monitoring will not go away.
It can’t. Its scope is a critical component to help
ensure squeaky clean data and utmost patient
safety. Yet, according to study results, if sponsors and service providers are to relieve stubborn
industry-wide financial pressures and meet growing industry demands, clinical monitoring must
begin to morph into more of a hybrid model—at
least in the later phases of clinical trials. As one
respondent aptly put it, “There is a large area of
opportunity to improve how clinical trials are
conducted. Hopefully the combination of new
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September 2013
technologies and alternative models can help to
improve monitoring and data quality.”
What’s in it for sponsors and CROs?
Consider these study results a wake-up call to
action. The report details the overall awareness,
interest, and likelihood that alternative models
would be adopted for clinical monitoring; it exposes the barriers to adopting these models; it
outlines appropriate phases of development for
the various mix of monitoring models; analyzes
the best pricing models for this highly outsourced
activity; and broadens the industry’s understanding of how the clinical monitoring environment
will likely change over the next few years.
Merging industry forces lead to change
While the biopharmaceutical industry can be slow
to change, current commercial forces are working
to accelerate the adoption of adaptive monitoring designs. These forces (a struggling economy,
lack of novel drugs in the pipeline, mega mergers,
sub-par financial performance, and the patent
cliff) will impact clinical monitoring, just as it has
impacted other facets of biopharma.
Many companies saw the handwriting on the
wall early on. In the late 1990s, Novella Clinical
began to test new monitoring models, utilizing
EDC for both data capture and remote review.
Today, Novella utilizes a combination of onsite and centralized monitoring to effectively
monitor clinical studies. On-site monitoring allows monitors to assess study documentation,
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Table of Contents for the Digital Edition of Applied Clinical Trials - September 2013 - Supplement
Applied Clinical Trials - September 2013 - Supplement
Contents
What Does the Future Hold for Clinical Monitoring?
Risk-Based Monitoring: A Primer for Small to Mid-Size Sponsors
Targeting Source Document Verification
Triggered Monitoring
Overcoming the Concerns Associated with Risk-Based Monitoring
Applied Clinical Trials - September 2013 - Supplement
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