When you can`t afford a delay in patient enrollment,

Transcription

When you can`t afford a delay in patient enrollment,
When you can’t afford
a delay in patient enrollment,
Acurian is the only viable option for keeping
enrollment on track.
We deliver the patients you need, when you need them,
at the price we quoted.
When you can’t afford a delay in patient enrollment, you can’t
afford NOT to use Acurian
Especially when you compare these costs…
✓✓ Missed key milestones
✓✓ Delayed time to market
✓✓ Adding more sites, countries
✓✓ Time and money wasted on novice recruitment
suppliers
…to the value of Acurian
✓✓ The patients you need, when you need them
✓✓ More patients per site
✓✓ Sterling track record of on-time enrollment
performance
✓✓ Results-based pricing that is often less than adding
sites or time
In the following case studies, Acurian used IMS CRO CostPro® analyses to
demonstrate that not only did Acurian quickly get patient enrollment back
on track, but as a replacement cost for other options, was significantly more
cost-effective.
Acurian Saved Eight Crucial Months of Enrollment Time for a Global
Gout Program
This phase III global program was critical for the
sponsor, as it was striving to make its compound
the leader in a potential $1B gout market by 2018.
After five months of enrollment, sites‘ databases
were exhausted.
All sites were significantly behind in enrollments.
Months to Complete Enrollment
Acurian
enrollment of
525 patients
17 Months
Wait for 252 sites
to complete
enrollment
Acurian was hired to support 252 sites in the US
and 100 sites in five other countries.
Acurian worked closely with the sponsor’s two CROs
and exceeded expectations by delivering 30% of the
study’s randomizations.
25 Months or More
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5
10
15
Months
20
25
30
Cost of Enrollment Options
14
$12.4 M
$13.1 M
12
$9.3 M
10
$ Millions
The Cost Efficiency of Acurian
Acurian cost $3.8 million less than waiting 25 or more
months for sites to find enough patients, and $3.1
million less than adding 108 sites, which would have
been required to reach the same enrollment volume
in the same period of time.
8
6
4
2
0
Add 108 Sites
(360 Total)
Wait for 252 Sites
to complete
enrollment
Acurian
Thanks to Acurian, This Sponsor Won its Race to Market with
a New Class of OIC Drug
For the sponsor, the financial stakes were enormous.
Being first to market could mean capturing a major slice
of a multi-billion dollar pie. Hence, every day counted.
Acurian was hired at study start to accelerate
enrollment.
We supported 401 sites, increased the site enrollment
rate by 77%, and delivered 44% of all patients.
Months to Complete Enrollment
Acurian
enrollment of
924 patients
14 Months
Wait for 401 sites
to complete
enrollment
All subsequent timelines were met.
The drug received FDA approval, and the sponsor was
able to leapfrog its major competitor to market.
25 Months or More
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5
10
15
Months
20
25
30
Cost of Enrollment Options
$30.0
$25.6 M
The Cost Efficiency of Acurian
Given the actual in-practice site enrollment rate, the
sponsor would have needed to activate another 310
sites to meet its randomization targets in 14 months.
$ Millions
$25.0
$20.0
$15.0
$10.9 M
$10.0
Acurian was able to deliver enough randomizations
to complete enrollment for $13.9 million less than the
cost of adding sites.
$5.0
$0.0
Add 310 sites
(771 total)
Acurian
Acurian Rescued a Cardiovascular Outcomes Mega-Trial
Long-duration trials are tough on enrollment rates,
and this study was no exception.
The sponsor planned for 20,581 patients from 881
sites over seven years. However, at year six, sites had
lost steam and a significant shortfall of 1,986 patients
at the end of year seven was projected.
Acurian was hired at the end of year six to revitalize
study enrollment by supporting 271 of the 881
participating sites with patient recruitment for one year.
In one year, Acurian increased the site enrollment rate
by 343%, which avoided a two-year delay.
Years to Complete Enrollment
Acurian
added at year
six to assist
271 sites
6 Years
Wait for 881
Sites to
Complete
Enrollmentt
1 Year
9 Years
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1
2
3
4
5
6
7
8
9
Cost of Enrollment Options
$140
$120
$100
$ Millions
The Cost Efficiency of Acurian
Acurian cost $107.2 million less than waiting for sites
to complete enrollment.
$119.2 M
$80
$60
$40
$20
$0
$12.0 M
Wait 2 additional
years for 881 sites
to complete
enrollment
Acurian
Acurian Completed Enrollment 113% Faster Among US Sites
to Rescue a Global Diabetes Study
This was an important Phase III clinical trial designed
to confirm efficacy and safety of the sponsor’s
compound.
In the US diabetes market, even the capable sites
were struggling to find enough patients in the face
of very specific enrollment challenges.
The enrollment rate was much lower than anticipated,
and timelines were in significant jeopardy. Acurian
was hired to provide recruitment support for two
months, then for another two months.
Months to Complete Enrollment
Acurian
enrollment
support
Wait for 70
sites to
complete
enrollment
Enrollment was accelerated by several months.
Acurian exceeded its commitment (105% of goal) and
delivered 120 randomized patients within budget.
The Cost Efficiency of Acurian
Acurian cost $2.7 million less than adding 125 sites
which would have been required to reach the same
enrollment volume in the same period of time.
(Based on US site productivity
17+ months
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4
6
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10
12
14
16
18
Cost of Enrollment Options
$8.0
$7.0
$7.0 M
$6.0
$5.0
$ Millions
•Increased the site enrollment rate by 94%.
•Contributed 48% of all patients enrolled in the US.
•Enrollment was completed 113% faster compared
to how sites alone were on track to deliver.
8 months
$4.3 M
$4.0
$3.0
$2.0
$1.0
$Add 125 sites
(195 total)
Acurian
Acurian, Inc. is the global leader and industry specialist offering ways to enroll
trials faster and more cost efficiently. We do this by consistently giving clinical trial
managers more randomized patients-per-site, faster enrollment, and lower costs.
For over 15 years, our comprehensive solutions have helped sponsors efficiently
enroll and retain the patients they need, when and where they’re needed.
When you can’t afford a delay in patient enrollment
www.acurian.com
[email protected]
215.323.9000