ACURIAN CASE STUDY:

Transcription

ACURIAN CASE STUDY:
ACURIAN
CASE STUDY:
Predictable, reliable, and
measureable results
Acurian is Delivering 48% of all Randomizations
for a Global Pediatric Depression Program
This Phase III, two-protocol program (ongoing) is critically important for a sponsor hoping to extend the label of its
antidepressant drug (currently available for adults only) to children and adolescents.
The Enrollment Challenges
• Children rarely say, “I’m depressed,” and parents
may not recognize the symptoms.
• Parents may not feel comfortable acknowledging
their child’s depression or know how to
communicate with their child about depression.
• Parents are particularly reluctant to enroll their
children into antidepressant studies.
• The protocol requires numerous weekly
appointments, which could be difficult for busy
parents.
The Enrollment Scenario
• At study start, the goal was to complete enrollment
by the end of 2014.
• With all the challenges, the clinical trial team soon
realized that not only were enrollment timelines
unrealistic, but that achieving randomization goals
would be extremely difficult, if not impossible,
without central recruitment support.
• Acurian was hired to work with 100 global sites to
deliver 390 randomized patients over 16 months.
To date, 66 sites remain in the study.
• Currently, Acurian has exceeded sponsor
expectations and accounts for 48% of all study
randomizations.
How we did it
Acurian was ideally suited to support this study.
Since 2007, we successfully managed 20 studies
seeking a younger population and 69 CNS studies.
In addition, we have referred over 76,000 prescreened qualified patients with a CNS-related
disorder to study sites.
The Marketing Campaign
After surveying several thousand households about
childhood depression, Acurian designed two sets
of materials: one for parents of children (7-11) and
one for parents of adolescents. Selected materials
were customized to country-specific needs, and great
care was taken to meet the sponsor’s health literacy
standards. The campaign tactics included:
• Direct mail (US only) targeted to 7.7 million optedin depression contacts (30% indicating children
in household) from Acurian’s proprietary database
of 70+ million people.
• eRecruitment (online health networks, keyword
campaigns, display ads, social networking)
• Television, radio, print
• Patient engagement and education video to help
parents understand and commit to the study
• Landing page for online screener (50% of people
prefer to screen online)
(see other side for campaign results)
Campaign Results to Date
Currently, Acurian accounts for 51% of all screens and 48% (428) of all randomizations.
Months to Complete Enrollment
Because Acurian has increased
site enrollment rates by +92%,
the current level of enrollment
has been reached 63% faster
compared to how sites alone
were on track to deliver.
Acurian
recruitment of
428 patients
.763 patients/site/month
Wait for 66 sites
to complete
enrollment
.398 patients/site/month
27 months
44 months
or more
l
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0
5
10
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35
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Patients Completing
Randomized Treatment
Analysis shows that the quality of Acurian patients
is similar to in-practice patients, with 61% of
Acurian patients completing randomized treatment
compared to 64% of non-Acurian patients.
100% –
90% –
80% –
165
patients
167
patients
70% –
60% –
50% –
Dropped out
40% –
30% –
Completed
263
patients
302
patients
Acurian Patients
(428 Randomizations)
In-Practice Patients
(469 Randomizations)
20% –
0% –
The Cost Efficiency of Acurian
To date, Acurian central recruitment has cost $1.5 million
less than waiting 44 or more months for sites to find
enough patients, and $1.3 million less than adding 40 sites
in order to reach the same enrollment volume in the same
period of time.*
*IMS CRO CostPro® analysis
The Enrollment and Retention Specialist
Total Cost of Enrollment Option ($Millions)
10% –
Cost of Enrollment Options
8 –
7 –
$7.2 M
$7.4 M
$5.9 M
6 –
5 –
4 –
3 –
2 –
1 –
0 –
Add 40 Sites
(106 Total)
Wait for 66 Sites
to complete
enrollment
Acurian
Recruitment
of 428 Patients
COMPLETE ENROLLMENT WITHOUT
ADDING SITES OR TIME
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.
www.acurian.com