poster

Clinical Trial Monitoring: A Remote Real-Time Source Document Verification
Program between Memorial Sloan Kettering Cancer Center (MSKCC) and
Sponsors
Michael Buckley, Paul Sabbatini M.D., Collette Houston, Gregory Riely M.D Ph.D., Kristen Ahearn, Rich Jankowski, Jonathan Walland, Janet Murdock, and Ann Dilworth
Abstract
Traditional sponsor monitoring of clinical trials relies on labor-intensive onsite visits to perform source document data verification of a patient’s
Electronic Medical Record (EMR). These activities are directly associated
with high costs due to sponsor travel, space accommodations for monitors
att the
th site,
it and
d consumption
ti off valuable
l bl staff
t ff time
ti
and
d effort.
ff t
Results
Pilot Success Metrics
Data Verification Rate
4 6 weeks  Weekly
4-6
Streamline
Existing Process
by Leveraging
MSKCC
Technologies
(EMR, IT)
Measure
Quality
Query Resolution
2-4 weeks  5 days
REMOTE
Deliver
Increased Communication
MONITORING
Patient Care
2-4 weeks  Real-Time
Partner with
External
Stakeholder to
Share the Cost of
Improving an
Existing Process
In an effort to address these shortcomings, MSKCC launched a feasibility
pilot in 2010 in partnership with Novartis (NVS). We created a secure and
novell remote
t EMR access and
d source document
d
t verification
ifi ti paradigm
di
th t
that
allowed us to:
1) decrease the cost of the existing process,
2) hasten source data verification by increasing monitoring visits,
3) increase turnaround time of query resolution, and
4) increase productivity for both the sponsor and site.
Methods and Materials
Existing MSKCC information security and clinical information systems onsite
monitor access paradigms were leveraged, with the addition of a specialized
MSKCC issued remote monitoring laptop that complies with current industry
security best practices. In accordance with FDA and GCP objectives,
monitors continue to visit MSKCC in person to meet with Pharmacy,
Principal Investigators, and the study team.
Trials with unexpected sponsor data locks and interim analysis that need to
b completed
be
l t d quickly
i kl leverage
l
th remote
the
t monitoring
it i program to
t ensure
data timelines are met.
Program provided an opportunity to leverage existing MSKCC best practices
for:
1) Electronic Medical Record (EMR) access
2) Information Systems
3) Compliance
Scalability remains an issue for this program, and we are currently
evaluating technologies via a web-based monitoring portal. Using a secure
web-based portal that allows monitors to access the patient’s EMR data will
eliminate the need for laptops, and expand the program to additional
sponsors.
Productivity
Conclusions
Reclaimed 3h Per Visit
IIncreasing
i data
d
verification
ifi i visits
i i via
i remote access to the
h MSKCC Electronic
El
i
Medical Record (EMR) with this program has the potential value-add to
augment patient safety and study oversight by allowing more real-time
access, in the case of monitoring, to source data, adverse events, reactions,
and dosing information.
Cost Savings
Introduction
Discussion
Space constraints for onsite monitoring at MSKCC have been alleviated by
this program.
The 2010-11 feasibility pilot was conducted and expanded to two NVS
monitors in 2012. In 2012 two NVS monitors remotely monitored 20 MSKCC
trials with a NVS estimated savings of $70,000/year.
By reducing historical face time with study coordinators from 4 hours per
monitor visit to 1 hour (fixed appointment) per visit, we reclaimed 3 hours
of time and effort from each visit, which was reallocated. By simple
calculation, this represents 3 hours per monitoring visit or $24,138
estimated time and effort for 2012.
The FDA’s position on remote monitoring is evolving (ref.) In the past FDA
guidance documents insisted that monitoring always needed to occur
onsite. .
Program success metrics are continually tracked and insure continued
adherence with FDA and GCP objectives.
The rate of source data verification increased by adding additional
monitoring visits from once per month to once per week per trial.
Reference
Turnaround time of query resolution went from 2-4 weeks to 5 days.
Contact
These successful outcomes allowed the addition of a third monitor from
Bristol-Myers Squibb (BMS) to be added to the program in 2013. In April
2014 the program expanded to a total of five monitors, with further
expansions planned to two CROs in Q3 2014.
Michael Buckley
Enterprise Clinical Research Innovation Manager
Memorial Sloan Kettering Cancer Center
Email: [email protected]
Website: www.mskcc.org
Phone: 347-852-5169
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf

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