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- The Heart Research Follow-up Program (HRFUP) is
dedicated to directing cardiovascular research
studies for the purpose of improving cardiac
care. The HRFUP, under the direction of Dr.
Arthur J. Moss, has extensive experience in the
design, conduct, and analysis of world-wide,
multicenter, clinical research studies ranging
from 100-3500 subjects. In all of the studies,
the HRFUP has consistently met specified
enrollment numbers by recruiting strong capable
enrolling center investigators, effectively
coordinated multicenter activities including
maintenance of regulatory standards, maintained
proper quality control of large amounts of data,
used sophisticated multivariate analytic methods,
published definitive reports in major journals in
a timely manner following completion of each
study, and assisted with data submissions as
requested by the study sponsors and the FDA. One
hallmark of the HRFUP is to statistically design
cost-effective studies using sequential analysis
techniques to potentially allow for early study
termination. Another hallmark of the HRFUP is to
maintain strict rules of data safety/monitoring
to insure investigator and sponsor independence
and data integrity to facilitate rapid product
approval from the FDA. The HRFUP has an
outstanding reputation for scientific excellence.
As an academic-based, full-facility research
center with access to a vast array of University
based services, the HRFUP can provide the highest
professional standards to meet all the aspects of
the diverse management requirements of
cardiovascular research studies.
- The HRFUP has a staff of highly trained professionals
who have extensive experience in all aspects of
management and coordination of research studies.
The HRFUP in-house quality assurance and
management allows the conduct of studies that
exceeds FDA standards. The HRFUP has direct
access to world-class biostatisticians with vast
experience in project design and analysis. The
HRFUP conducted one of the first device trials
utilizing sequential analysis that saved
considerable money for the sponsor through early
termination and FDA submission. FDA submission
and labeling approval was also accelerated,
because the data for this project was delivered
directly by the HRFUP. The HRFUP has an in-house
mainframe computer to accommodate all aspects of
data management. The HRFUP has access to leading
core laboratories such as hematology,
lipidemeology, or angiography to analyze any
ancillary tests that may be required. The HRFUP
in conjunction with the University can also
provide support for all contractual and
regulatory needs including rapid IRB approval.
- The HRFUP has also been involved in electrocardiology
research for over 20 years. The main focus of
this research is on ventricular arrhythmias and
ventricular repolarization analyses. The HRFUP
ECG core laboratory is prepared to conduct
analysis of all types of ECG recordings including
standard 12-lead ECG, signal-averaged ECG
(SAECG), digital high-resolution ECG, and analog
or digital long-term 24-hour Holter recordings.
The HRFUP is equipped to scan and digitize a
paper copy of an ECG to accomplish a more
sophisticated computer analysis. The HRFUP is
fully equipped and prepared to conduct computer
analyses of various high-resolution and long-term
digital ECG recordings. The HRFUP has developed
computer programs that interpret various aspects
of ECG changes including, but not limited to,
repolarization analysis in standard and long-term
recordings, atrial and ventricular arrhythmia
analyses, ST-T segment evaluation, P-wave and QRS
signal-averaging, and heart rate variability
analyses. The HRFUP ECG analytic facilities are
merged with a central computer clinical data
management system that has been developed and
validated over a period of 20 years.
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