Background: HRHR has participated in numerous research studies
designed to evaluate investigational medications for allergic
rhinitis. The studies required rapid enrollment of a large number
of patients with proven environmental allergies. Enrollment was
competitive with short windows of opportunity to enroll adequate
numbers of patients.
Study Execution: Rapid start up inclusive of central IRB submission,
patient screening and aggressive recruiting strategies were the
key to successful study enrollments and early completion of these
trials.
Responsibilities included: Aggressive recruitment objectives;
close management and communication of results with study sponsor
during the trial; acquisition of valid, evaluable and generalizable
data.
Study Results: Knowing that the clients expected rapid enrollment,
aggressive strategies were put in place to pre-screen patients
and have them available for immediate screening/enrollment upon
study start. As a result HRHR far exceeded the contract enrollment
goal in all studies. A significant volume of evaluable data was
obtained and patient satisfaction, based on a standard study exit
survey, was high. HRHR's recruiting strategy exemplified HRHR's
commitment and confidence in meeting sponsor's goals and objectives.
HRHR far exceeded the sponsor's expectations and was a major contributor
to the drug development timeline.
Key to Success:
Experienced
clinical research team;
Efficient IRB process
utilizing a centralized IRB; and
Aggressive recruitment
strategy in advance of study start up for rapid
enrollment at study initiation.
