Download total supply chain assurance program turns around global trial

CASE STUDY
TOTAL SUPPLY CHAIN
ASSURANCE PROGRAM TURNS
AROUND GLOBAL TRIAL
INTEGRATED TECHNOLOGY AND SERVICES HALTS
STOCKOUTS AND STEMS PATIENT LOSS
End-to-end supply chain solutions that encompass technology and
management services are not mere matters of convenience; they actually
improve study efficiencies that translate into savings. When the same
partner provides the trial forecast, drug supply strategy, and the
interactive response technology, the study benefits from a
virtuous cycle of information. Processes are coordinated
to ensure that the right drug is on hand at sites at the
right time. One sponsor came to appreciate
these benefits after the company’s Clinical
Supply team first attempted to perform
the forecast and devise the supply
strategy themselves.
IT BECAME
CLEAR THAT
SOMETHING
WAS AMISS
IN ONE YEAR, 838
PATIENTS WERE BEING
TURNED AWAY AT THE
SITES BECAUSE THERE
WASN’T ENOUGH
OF THE RIGHT DOSE
STRENGTH IN THE
RIGHT COUNTRY AT THE
RIGHT TIME TO MEET
THE PATIENT DEMAND
THE SITUATION: SUPPLY AND
DEMAND NOT SYNCHED
The sponsor of a Phase III trial
spanning more than 700 sites in 49
countries turned to Almac for its
interactive response technology,
IXRS®, and for kit production and
distribution. The sponsor’s own
Clinical Supply team furnished the
drug forecast and the resupply
strategy. After the first year of
the trial, which was to run for
nine years, it became clear that
something was amiss. The rate
of insufficient product alerts
generated by IXRS rose sharply,
reaching a high of 4.7 percent
in the second year of the trial.
This meant that in one year, 838
patients—between two and three
a day—were being turned away at
sites because there wasn’t enough
of the right dose strength in the
right country at the right time to
meet patient demand.
The randomised, double-blind trial
was challenging for the sponsor to
supply because:
•
The sheer number of countries
involved created great
complexity
•
There were extreme peaks and
troughs in product demand
due to the recruitment pattern
•
The dosing was titrated, and
different kits were required at
different visits
•
The patient visits were many
months apart, while the
product’s shelf life was 18
months
As a result, the resupply strategy
was not synched with actual
patient demand, and frustration
was mounting at clinical sites
as well as within the sponsor’s
Operations team. An inordinate
number of patients were leaving
the study and enrolling in
competing trials, of which there
were many.
ALMAC
MANAGERS
WERE ABLE
TO IDENTIFY
THE TWO
ROOT
CAUSES
OF THE
PROBLEM
THE SOLUTION: A CLOSED LOOP SYSTEM OF
FORECASTING, TRACKING, AND RESUPPLY
ALMAC EXPERTS
DEDICATED
THEMSELVES TO
PREPARING A
NEW RESUPPLY
STRATEGY AND THEN
RECONFIGURING IXRS
TO EXECUTE THE
STRATEGY
Immediately, two Almac experts—one with a specialty in supply chain
management technology and the other with a deep background in supply
chain planning—dedicated themselves to preparing a new resupply
strategy and then reconfiguring IXRS to execute the strategy. Because
all of the necessary expertise resided within Almac, we were able to
recommend a solution to the sponsor in just a week.
In consultation with the sponsor, Almac managers were able to identify
the two root causes of the problem:
1. The sponsor’s initial forecast was not being updated to reflect
actual product demand based on recruitment trends and study
progress
2. Production was not being implemented in time to replace used /
expired product in the supply chain.
Understandably, the sponsor’s Clinical Supply team needed expert help
from specialists in order to manage a study of this size and complexity.
Almac presented the sponsor with a new forecast produced by our
Supply Wise™ forecasting tool. The obvious differences between Almac’s
forecast and the one the sponsor had been using convinced the sponsor
that Almac should assume responsibility for regularly forecasting product
demand, revising the supply strategy, and harmonising production
campaigns with the forecast.
THE RESULTS: OPTIMISED PRODUCTION AND DISTRIBUTION
20+8+6+4+4+2
Throughout the life of the trial, Almac continued to update the supply
forecast, an exercise made both efficient and accurate by the fact that
Almac’s IXRS system provides real-time updates on patient enrolment,
product usage, and expiry dates directly into Supply Wise™.
Over time, as the sponsor’s product production “caught up” with Almac’s
forecast, the rate of insufficient product alerts dropped sharply from its
high of 4.7 percent to a reasonable 0.2 percent, patient discontinuations
decreased dramatically, and complaint calls from sites dropped in equal
measure. (See Figure 1.).
Figure 1: Insufficient Product Alerts
Total IXRS Drug Assignments
17,907
29,332
16,981
15,369
14,232
1,173
Year
2011
2012
2013
2014
2015
2016
Failure Rate (Alert %)
4.7%
0.9%
0.6%
0.3%
0.3%
0.2%
7.97%
4.52%
2.73%
2.73%
0.22%
Patient Discontinuation Rate (%) 3.48%
www.almacgroup.com
WITH THE TOTAL
SUPPLY CHAIN
ASSURANCE PROGRAM,
THE SPONSOR WAS
ABLE TO BUDGET
MORE REALISTICALLY,
PREVENT WASTAGE IN
THE SUPPLY CHAIN,
AVOID STOCKOUTS,
AND RETAIN PATIENTS
IN THE STUDY
The rate of patient discontinuation was at its height in 2012 when nearly
eight percent of enrolled patients exited the study. While certainly not all
of the discontinuations were attributable to drug stockouts, let’s assume
that a modest 10 percent were. Based on that assumption—and knowing
that the average cost of recruiting and retaining each patient in a study is
$25,000—we can calculate the sponsor’s Return on Investment (ROI) by
using the Almac Clinical Forecasting Services.
Between 2012 and 2013, a total of 202 fewer patients dropped out of the
study, 20 of which we assume to be related to the improved drug supply.
Thus, between 2012 and 2013 alone, every dollar spent on Almac’s
intervention saved the sponsor an estimated $14, for a remarkable ROI
of 1:14. Overall, based on very conservative estimates, the sponsor
saved the staggering costs (easily amounting to more than $1 million) of
replacing scores of patients over the long course of this very large trial.
In addition, the sponsor was able to keep the trial on track in meeting its
deadlines.
Coordinated oversight of the entire supply chain was key to optimising
both production and distribution. With the Total Supply Chain Assurance
Program, the sponsor was able to budget more realistically, prevent
wastage in the supply chain, avoid stockouts, and retain patients in the
study.
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