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Primary Research- Division of Biostatistics
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Primary Research Strengths
Research activities of the Division of Biostatistics span a wide range of topics dealing with
clinical, epidemiological, and genetic studies of a number of disorders of considerable public
health importance, providing research opportunities at both theoretical and applied levels.
Several research projects involve close interaction and collaboration with a number of research
groups at the Medical Center. The present core research programs of the division deal with
clinical trials, coordinating center activities, and family studies and genetic epidemiology.
The Clinical trials core research focuses on the development and implementation of research
protocols for collaborative research both within the University and with collaborators across the
country. The division actively contributes to all facets of the studies, including the design of
the trials, sample size calculations, protocol development, database management, quality control,
analysis of data, and manuscript preparation.
Coordinating Center (CC) activities for managing large multi-center studies have been a major
focus of the Division since the late 1980's. This role builds on the research experience
established in both Clinical Trials and Genetic Epidemiology. Most of these projects work under a
UO1 or linked RO1 mechanism, where the Coordinating Center (Division) works actively and closely
with the Steering Committee (which includes all study center P.I.s and the NIH). The coordinating
centers play a major role in all aspects of the studies, including the research protocol,
development of an intelligent data entry and management system, quality control, tracking
recruitment, data analysis and publications, and producing informative and timely reports for the
Steering Committee and the Monitoring Board.
The Genetic Epidemiology research, especially as it relates to cardiovascular disease, delves into
a number of theoretical and applied problems, including: nature-nurture resolution and
identification of the genetic basis of risk factors such as lipids, lipoproteins, apolipoprotiens,
obesity, blood pressure, sex hormones and glucose tolerance; preclinical expressions of
atherosclerosis, measures of inflammation, exploration of temporal trends in the degree of
genetic and environmental effects; and multivariate associations among multiple risk factors;
and localizing, identifying the genes and delineating their etiologies for complex traits.
Timely theoretical issues also are addressed, such as the optimal sampling designs for of families
through patients family studies, and the statistical properties of methods of data analysis, and
the development of new methods and models for testing linkage and association (disequilibrium)
hypotheses, especially as they relate to genome-wide scans, challenges of heterogeneity, and
combining evidence across multiple studies.
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Biostatistical Core Facilities- Division of Biostatistics
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Biostatistical Core Facilities
Biostatistics Cores generally provide support in the areas of data management, quality control,
and data analysis to a Medical Center project. A typical core develops the data entry system,
checks the data for quality, produces reports for the P.I. and carries out analysis of the data.
The core also assists the P.I. in the design of the trial and the protocol development.
Recent/Current Major Biostatistical Core Facilities supported by the Division of Biostatistics
are:
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Biostatistics and Clinical Trials Core
of the Alvin J. Siteman Cancer Center.
(J. Philip Miller, Core Director) - Research in cancer prevention and treatment.
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ADRC
(Johnson, P.I.; Phil Miller, Core Director) - Alzheimer’s Disease Clinical Research. Data management and analysis for over 20 years of
longitudinal data. Affiliated projects explore the neuropathologic, behavioral, and genetic
aspects of AD and other dementia.
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HASD
(John Morris, P.I.; Phil Miller, Core Director) - Healthy Aging and Senile Dementia. Study of clinical and biomedical
correlates of the clinical course of Dementia of the Alzheimer’s Type (DAT) in comparison with
healthy aging.
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Pepper Center
(John Holloszy, P.I.; Ken Schechtman, Core Director) - Effects of exercise and Hormone Replacement Therapy (HRT) on physical
functioning.
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Asthma SCOR
(Holtzman,P.I.; Ken Schechtman, Core Director) - Clinical and Lab projects to delineate the mechanisms of airway
inflammation.
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Hypertensive Veterans Study
(Perry, P.I.; Phil Miller, Core Director) - Surveillance of 100,000 veterans for mortality and hospitalized morbidity.
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Cell Interaction and Hypoxic Brain Injury
(Dennis Choi, P.I.; Mike Province, Core Director) - Stroke and the role of AMPA receptors in brain injury.
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Excitatory Transmitters, Memory, Aging, and Dementia
(Olney,P.I.; Phil Miller, Core Director) - The role of excitatory transmitters in memory, aging, and dementia.
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Epidemiological Genetics and Family Study
(Cloninger, P.I.; D.C. Rao, Core Director) - Provides statistical consultation to the CRC sponsored projects.
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Other Campus Collaborations- Division of Biostatistics
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Other Campus Collaborations
The Division of Biostatistics has a number of collaborations within the Medical Center.
Faculty and staff members provide biostatistical support in several areas including protocol
development, data management and quality control, and data analysis. These collaborations are
not formally considered as Biostatistical Cores, but they function much the same way. Some of
the Major Recent/Current Collaborative Efforts are:
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Biobehavioral Markers of Infant Pain and Temperament
(Fran
Porter Lang, P.I.) - Study of infants’ response to pain.
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Quantitative Ultrasonic Imaging for Myocardial Viability
Use of tissue characterization to identify viable by dysfunctional
myocardium.
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Cognitive Change in Cerebrovascular Disease
(John
Morris, P.I.) - Longitudinal study of patients with cerebrovascular compromise
to assess clinical and cognitive change.
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Adaptations to Exercise in Older Hypertensive Subjects
(Ehsani,
P.I.) - Study of how to adapt exercise in older subjects with hypertension.
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Neuromorphometry in Schizophrenia by Computer Algorithm
(Csernansky,
P.I.) - A study of neuromorphometry in schizophrenia patients.
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Rehabilitation Intensification Post Hip Fracture
(Ellen
Binder, P.I.) - Study of hip-fracture rehabilitation with exercise.
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Asthma and Interventions in the Emergency Department
(Strunk,
P.I.) - A prospective, randomized trial to test the effectiveness of ED-based
interventions to increase follow-up to primary care provider after and
ER visit for asthma.
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Improving Cognitive Performance: Linking Biology, Environment, and Behavior
(Carolyn
Baum, P.I.) - A study of cognitive performance.
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Genetic Biologic, and Immunologic determinants of Asthma
(Castro,
P.I.) - A study of the determinants of asthma.
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Evaluation of Neonatal Brain Injury via Water diffusion
(Neil,
P.I.) - A study of neonatal brain injury.
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Imaging Multi-Drug Resistance and Modulation in Breast Cancer
(Piwnica-Worms,
P.I.) - Study of imaging multi-drug resistance and modulation in breast
cancer.
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W. U. Small Animal Imaging Resource
(Ackerman,
P.I.) - A comparison of serval methods in imaging of small animals as a
demonstration population.
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Precipitation of MS Exerbations by Urinary Tract Infections
(John
Trotter, P.I.) - The study of how urinary tract infections exacerbates
MS symptoms.
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Evaluation of the take-charge ADHRD Program for Women and Female Adolescents with
HIV
(Linda
Mundy, P.I.) - Adherence study to determine if the take-charge ADHRD program
results in a higher proportion of cases with sustained adherence to HAART.
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Screening for Silent Strokes in Sickle Cell Disease
(Michael
DeBaun, P.I.) - A study to determine screening methods for the detection
of strokes in sickle cell patients.
In
addition to the above, faculty and staff are involved in many on going
collaborations though the Biostatistics Consulting Service. For more information
on this service, click here
consulting
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Multi-Center Family, Genetic & Clinical Trials- Division of Biostatistics
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Multi-Center Family, Genetic and Clinical Trials
The
Division of Biostatistics is involved in many multi-center family and genetic Studies, and
multi-center clinical trials for which it serves either as a Coordinating Center or a Data
Coordinating Center. Genetic studies all involve recruitment of families, collection of
phenotypic data as well as the collection and analysis of genotypic data. Clinical trials
studies involve the recruitment of subject who participate in a clinical intervention.
As a Data Coordinating Center, the division assists the project by developing
a central data entry and management system, checking the data for errors,
tracking recruitment and publications, developing and producing reports the the Steering
Committee, NIH, and a Monitoring Board, and analyzing the data collected and publishing the
results. In addition to the above, as a Coordinating Center, the division is also responsible
for a number of administrative tasks that include taking and distributing minutes from each
meeting and conference call, and the development of the study Manual of Procedures.
Development of intelligent data entry systems is one of the special talents of the division. This
system has on-line quality checks that will bounce an out of range value back to the data entry
person immediately and the entry must be checked and reentered after verification. It also uses a
double data entry process whereby one enters the data and then another data entry person enters
the data a second time. If the two entries do not match exactly, there is immediate feedback to
the second entry person, who must verify the information and reenter the value a second time if
necessary. This process forces the data entry personnel to check and recheck information that
may be questionable before the data are sent to the division for additional quality control checks
and integration with the master dataset from the entire project. It also saves the time it would
take for a less intelligent double data entry system to compare the
values at the Data Coordinating Center and then send non-matching entries back to the Clinical
Center to have recheck the values by comparing with the original data forms. Data entry errors are
kept to a minimum with such an intelligent double data entry system.
This type of system is now being used with Web-Based data entry also. Web-Based systems allow
immediate transfer of data to the data coordinating center. This reduces the time and effort
spent in mailing and uploading data from data disk or CD. The Web-based systems are being utilized
by several projects within the division and are considered the data management systems of the
future. Reports can be generated quicker, can be put on-line for immediate review by the
investigators, questionable values can be checked and the errors can be corrected faster.
New techniques for the development of these systems are being tested by the division in our
ever growing desire to make data entry and management as quick, easy and accurate as possible.
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Family & Genetic Studies (Recent/Current)- Division of Biostatistics
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Family
and Genetic Studies (Recent/Current)
The
NHLBI Family Heart Study, (FHS)
(Michael
Province, P.I.) - The division serves as the Coordinating Center for this
genetic epidemiological family study of heart disease. Extensive Family
History data were collected on 4,000 people (2,000 high risk and 2,000
random) and their families to determine the genetic risk of heart disease.
Of these families 1,200 (600 high risk and 600 random) were invited for
extensive testing including biochemical, pulmonary, ECG, and Carotid Ultrasounds.
Genotyping for candidate genes and genome-wide anonymous markers were also
performed.
Exercise
in Families Study, (HERITAGE)
(D.
C. Rao, P.I.) - The division serves the Data Coordinating Center for this
study of the genetic effects of exercise within families. Sedentary families
were measured before and after a 20 week program of standardized exercise
training. In addition, extensive phenotyping and genotyping were collected.
Hypertension
Genetics Study, (HyperGEN)
(D.C.
Rao, P.I.; Mike Province, Co-P.I.) - The division serves as the Data Coordinating
Center for this study of the genetics of hypertension. Detailed clinical
exams and extensive genotyping were performed on large samples of affected
sibpairs, mostly with stage 2 hypertension, and a random sample of subjects.
Family
Blood Pressure Program, (FBPP)
(D.C.
Rao, P.I.; Mike Province, Co-P.I.) - The division serves as the Program
Data Center for coordinating data activities among four multicenter Networks
studying the genetics of hypertension in a variety of populations. The
HyperGEN study above is one of those Networks. Several core variables have
been standardized across Networks (eg, Blood Pressure measured with Dinamap
and anonymous marker genotyping by Marshfield labs) to increase the sample
size of the pooled data.
Genetics
of Obesity and Its Co-morbidities, Quebec Family Study
(D.C.
Rao, P.I.) - The division provides genetic epidemiology expertise for this
study of the genetic components of body fat and fat distribution. |
Multi-Center Clinical Trials (Recent/Current)- Division of Biostatistics
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Multi-Center
Clinical Trials (Recent/Current) are:
CRISP
(Ty
Bae, P.I.; Phil Miller, Biostatistics Director) This clinical trial is
using imagining techniques to track the progress of Polycystic Kidney Disease.
Under the guidance of J. Philip Miller, the division will develop a Web
based data entry system and handle the data management tasks. They will
work closely with the ERL and the division of Radiology to track the progress
of the clinical centers and develop reports for the study centers, the
NIH, and the Monitoring Board.
EXCITE
(Phil
Miller, P.I.) in conjunction with Emory University, this study will try
interventions that speed recovery from strokes. The Data Coordinating center
will be responsible for development of the web based data entry system,
data management, tracking of recruitment and adverse events, overseeing
data collection and reporting. They will also assist in the analysis of
the data.
FICSIT
(Phil
Miller, P.I.). This was the first major Coordinating Center effort by the
Division of Biostatistics (1990 – 1996). This study focused on the prevention
of hip fractures. It was comprised of eight clinical centers that each
used a unique protocol. The individual center trials consisted of exercise
ranging from use of nautilus equipment to Tai Chi, home studies and risk
factors for falling, or the use of hip pads to prevent injuries in elderly
subjects. The Steering Committee found common assessments that were collected
at all centers and sent to the Coordinating Center to be analysed and used
to determine the successful interventions.
OHTS
(Mae
Gordon, P.I.; J. Philip Miller, Investigator) – Ocular Hypertension Treatment
Study. This is a randomized clinical trial of the safety and efficacy of
ocular hypotensive medication in preventing or delaying primary open angle
glaucoma in ocular hypertensive subjects at moderate risk. This study has
enrolled 1600 subjects in 22 participating clinics. The Division
of Biostatistics assists Dr. Gordon with the data management and analysis
of the data.
CLEK
(Mae
Gordon, P.I.; Ken Schecthman, Investigator) – Multicenter study of factors
which effect outcome in patients with keratoconus. This is an observational
study of 1200 subjects. The project looks at the natural history of the
disease and the clinical consequences resulting from this progression.
The Division of Biostatistics assists Dr. Gordon with data management and
analysis of the data. |
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