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INTRODUCTION
Emily Abbott JD, CPA
Monitor and coordinate the financial management of the
ATACH-II Clinical Trial for which cumulative funding awarded by
the National Institutes of Health is projected at $23 million.
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AGENDA
• Background of ATACH-II Clinical Trial
• General Barriers to Recruitment in Clinical Research
• Incorporation of a Mobile Application
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ATACH-II CLINCAL TRIAL BACKGROUND
• Antihypertensive Treatment of Acute Cerebral Hemorrhage
(ATACH-II).
• A Phase III Randomized Multicenter Clinical Trial of Blood
Pressure Reduction for Hypertension in Acute Intracerebral
Hemorrhage.
• Funded by the National Institutes of Health for 5 years with
a recruitment goal of 1,280 subjects.
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ATACH-II CLINICAL COORDINATING CENTER
• The ATACH-II Clinical Coordinating Center at the University
of Minnesota manages all clinical sites screening for
patients for the trial.
• Clinical sites located in the United
States, Japan, China, Taiwan, South Korea, and Germany.
• Future sites in Brazil, Canada, and other European
countries.
• Approximately 125 domestic and foreign clinical sites.
5© 2 0 1 2 M O B C O N ─ W H E R E M O B I L E M I N D S C O N N N E C T . A L L R I G H T S R E S E R V E D .
ATACH-II HYPOTHESIS
• Hypothesis
•Intensive systolic blood pressure (SBP) reduction using
intravenous (IV) nicardipine with treatment initiated within
4.5 hours of onset of ICH and continued for the next 24
hours reduces the likelihood of death or disability at three
(3) months after ICH by ten percent (10%) or greater
compared with standard SBP reduction.
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PUBLIC POLICY
• The trial will have important public health implications as it
will provide necessary information regarding the efficacy
and safety of antihypertensive treatment of acute
hypertension in subjects with ICH.
• BP treatment represents a strategy that can be made
widely available without the need of specialized equipment
and personnel, and therefore can make a major impact upon
outcome in patients with ICH.
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BARRIERS TO RECRUITMENT
Most common recruitment barriers:
• EMS / ED arrival time is after the allowable time window for
randomization *
• Inability to obtain consent within the allowable time window
for randomization
* Time window is 4.5 hours from symptom onset
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ADDITIONAL BARRIERS TO RECRUITMENT
Barrier to recruitment is heightened by multiple competing
interests for patients within the Emergency Department:
• Emergency Department is a difficult setting for referencing
source documentation.
• Initiation of patient to the trial through a web-based system
may be difficult due to competing demands for equipment.
• Time-Sensitive Availability of Research Team.
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INTRODUCE MOBILE APPLICATION FOR TRIAL
• The trial has incorporated the use of a mobile application to
facilitate subject enrollment for the trial.
• The ATACH-II investigators in collaboration with MentorMate
released the ATACH-II Patient Recruitment Guidelines mobile
application available on iPhone, Android, and Blackberry in
2011.
• This mobile application allows screening and randomization
through iPhone, Android, and Blackberry.
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DESIGN
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DESIGN
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DESIGN
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ATACH-II MOBILE APPLICATION
• This mobile application allows screening and randomization
through iPhone, Android, and Blackberry. Not only has this
application been widely adopted among investigators, other
time sensitive clinical trials have adopted similar
applications.
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CONCLUSION
Questions or Comments – Thank you.
© 2 0 1 2 M O B C O N ─ W H E R E M O B I L E M I N D S C O N N N E C T . A L L R I G H T S R E S E R V E D . #