Case Study: Overactive Bladder
The Sponsor: Predicting a Shortfall
An emerging biotech company was seeking to
file its first-ever NDA for a once-a-day oral agent
for overactive bladder. The company proactively
analyzed its site enrollment curve and discovered
investigators were going to be short by 65
percent. This virtually insurmountable gap could
only be closed by recruiting from the outside.
On top of that, the FDA ordered a last-minute
second phase III study to support the submission.
The sponsor was wary, however, to try a patient
recruitment vendor after a previous poor experience
with a recruitment firm that was good at invoicing,
but not so good at enrolling patients.
Acurian: Filling the Gap
Knowing we had extensive experience and a
database rich with overactive bladder (OAB)
patients, Acurian offered a recruitment approach
based on a rapid infusion of referrals and
pricing based on consented patients. The risk
was on us to deliver, and we did.
Within weeks we launched a recruitment
campaign to thousands of opted-in OAB
patients. Our project management team quickly
orchestrated all IRB and sponsor approvals;
activated our management and reporting
platform, Recruitment ManagerTM; trained 100+
sites and our centralized call center; developed
and distributed site kits and site-based recruitment
materials; and analyzed individual patient
availability for each site.
Over a five-month enrollment period, Acurian’s
site services team sent multiple waves of
direct-to-patient letters and e-mails to solicit study
participation, all while supporting sites with
appointment scheduling, patient reminder letters,
appointment reminders and other services
designed t ...