he George Washington University Biostatistics Center was
established in 1972 within the Department of Statistics.
The primary objective of the Biostatistics Center is to
provide statistical leadership in the design, execution,
and analysis of multi-center clinical trials and
epidemiologic medical investigations, and to insure that
the results of such studies are of the highest scientific
integrity and meet rigorous biostatistical standards.
These investigations include major medical research
programs, especially multi-institutional studies of
national and international scope, in both the public
and private sectors. Such research provides a testing
ground for new and developing statistical methods,
frequently leading to major advances in the field of
statistical methodology.
he
Biostatistics Center has participated in over 43 major
research projects, including both clinical trials and
case control studies conducted under the auspices of
the National Institutes of Health (NIH) and other
Federal agencies, and also in collaboration with
pharmaceutical companies in the private sector. In
addition, the Center participates in population-based
epidemiologic studies, and conducts grant-supported
research in biostatistical methods. Through these
activities, the faculty and staff of the Center have
published 198 articles related to statistical
methodology, clinical trials or epidemiologic methods,
and 342 articles presenting the results of medical
investigations, and 2 books.
Within the most recent five year
interval (1998- 2002) the Center has published 12
papers on biostatistical, clinical trials and
epidemiologic methods, and 84 which presented the
results of medical studies in which we have
participated. These citations are presented at
the end of this document.
 n
the role of coordinating center for collaborative
studies, the Center's functions include: statistical
design of the study; development of data collection
forms and manuals of procedures; all aspects of data
management with emphasis on adherence to protocol and
quality of data; training and certification of clinical
personnel; generation of monitoring reports; development
of new statistical methodology; statistical analysis of
results; and preparation of statistical and scientific
reports and publications.
he
Center is presently funded at over $29 million per year
as the statistical center for 16 research projects.
Fourteen of these are funded by the NIH. The total Center
staff of over 100 employees includes 26 statisticians,
8 doctoral or professorial, 18 M.S., approximately 58
computer systems analysts, programmers, research staff
plus data management and administrative personnel. The
Center's staff provides extensive experience in
biostatistics, epidemiology, clinical trials, case-control
studies, and database management.
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 TATISTICAL METHODS.
The application of state-of-the-art statistical methods
is required to insure that collaborative clinical trials
and epidemiologic studies meet rigorous scientific and
biostatistical standards. An important activity of the
Biostatistics Center is the evaluation and development
of new statistical methods to meet the unique needs of
planned or ongoing investigations.
TUDY DESIGN.
The careful design of the study plan in the successful
conduct of any scientific investigation is an essential
activity. The Biostatistics Center has actively
participated in the statistical design of all types of
medical investigations including multicenter therapeutic
and intervention clinical trials, and epidemiologic
cohort and case-control studies. Principal activities
include protocol preparation, sample size evaluation,
generation of randomization sequences and the
implementation of quality assurance programs.
 ATA MANAGEMENT.
The Center has established procedures for all aspects
of data management for the projects in which it
participates. This is necessary to insure that the data
which is analyzed and reported in scientific publications
is of the highest quality. This is a technologically
demanding task because some of these studies are among
the largest medical investigations conducted by the
National Institutes of Health. Data management activities
include forms design (and revision), centralized and
distributed data entry procedures (with verification),
extensive computerized data editing, computerized
updating of corrections to master files, and organization
of summary data files for specific statistical analyses.
TATISTICAL ANALYSIS AND PUBLICATION.
The ultimate aim of these activities is to allow
state-of-the-art statistical analyses of study results
in order to address the scientific objectives of each
study. The results of these analyses are usually
summarized in a report which is used as a basis for the
development of scientific manuscripts for publication.
Periodically during each study, interim analyses are
also performed to protect the welfare of patient
participants.
 DMINISTRATION.
In addition to these statistically-related activities,
the Biostatistics Center has an administrative division
which assumes various responsibilities associated with
managing a university-based research organization.
Direct on-site support services include financial
management, business administration, contract and grant
administration, and personnel services.
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