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BIOSTATISTICS, EPIDEMIOLOGY, AND RESEARCH DESIGN (BERD)




ASSISTANCE WITH STUDY DESIGN, DATA MANAGEMENT, QUALITY ASSURANCE, AND
STATISTICAL ANALYSIS OF DATA 

Director: Mohammad H. Rahbar, PhD - [email protected] - 713-500-7901

BERD provides leadership, expertise, and advice in biostatistics, epidemiology,
and research design to investigators in the CCTS. BERD’s mission is to
promote-within our CCTS-affiliated institutions as well as across CTSAs
nationwide-innovative, state-of-the-art clinical and translational research of
maximum public health benefit and scientific impact. BERD provides the resources
required to pursue the following objectives in support of the overall goals of
the CCTS.

 * Contribute to the enhancement and further development of the clinical and
   translational research infrastructure both within the CCTS and across CTSAs
   nationwide
 * Develop short-term and long-term collaborations between clinical and
   translational investigators and members of our CCTS network of experts in
   biostatistics, epidemiology, and research design
 * Contribute to the formal training of clinical and translational investigators
   in biostatistics, epidemiology, and research design
 * Contribute methodological advances in biostatistics, epidemiology, and study
   design of benefit to clinical and translational research

To achieve these goals, BERD will seize every opportunity (e.g., through
informal consultations as well as classroom instruction) to develop a
collaborative relationship with clinical and translational investigators
(primarily within our CCTS-affiliated institutions) to promote the rapid
development of innovative research ideas and the rapid dissemination of valid
research findings. Typically, this is a long-term process that begins with
providing assistance with study design and epidemiological and statistical
methods in the development of a research proposal, proceeding (most often
iteratively) with the acquisition of funding and, over the course of actually
conducting the study, producing findings and publications (most often
iteratively). The goals of BERD include collaboration with investigators to
optimize the often complex trade-offs between the research innovation, its
potential medical and public health impacts, and the required investments of
time and resources. BERD aims to reduce the number of iterations required to
successfully obtain research funding and to publish research findings.

BERD faculty, staff, and trainees also conduct their own clinical and
translational research and collaborate with leading statisticians in the Texas
Regional CTSA Consortium and the national CTSA program. 


BERD SUPPORT OPTIONS

Research support through BERD is available in the following capacities:
collaboration, consultation, and fee-for service contract. An initial BERD
consultation to assess an investigator’s research needs is offered free of
charge. For established, funded projects seeking an hourly fee-for-service
arrangement, a written contract will be provided. Such projects typically
require data management and statistical analysis. Whenever possible, we
recommend a collaborative arrangement in which a fixed percent effort of a BERD
faculty member is budgeted into the funding application. This prospective
arrangement has the advantage of assuring the investigator that the necessary
resources have been pre-negotiated and will be available when the application is
funded.

Please complete the BERD project initiation form for your inquiries.


LEADERSHIP AND FACULTY

Since February 1, 2008, Mohammad Rahbar, PhD, has served as the director of BERD
in the Center for Clinical and Translational Sciences. In 2012, Dr. Rahbar was
also appointed as the Director of the Division of Clinical and Translational
Sciences (DCTS) within the Department of Internal Medicine at UTHealth Houston
McGovern Medical School, which serves as the primary academic home for BERD
faculty.

Mohammad H. Rahbar, PhD ([email protected])

Professor of Epidemiology and Biostatistics & Director

Biography  /  Bibliography

Xu Zhang, PhD ([email protected])

Associate Professor of Biostatistics

Biography / Bibliography

Deukwoo Kwon, PhD ([email protected])

Associate Professor of Biostatistics

Bibliography

Wen Li, PhD ([email protected])

Assistant Professor of Biostatistics

Biography / Bibliography 

Sepideh Saroukhani, MD, PhD ([email protected])

Assistant Professor of Epidemiology and Biostatistics

Bibliography

For additional information about the BERD/DCTS faculty, please
see the division website for faculty profiles. 


BERD STAFF 

Manouchehr Hessabi, MD, MPH ([email protected] )

Program Manager-Research

Dr. Hessabi is a senior research scientist in BERD with more than 12 years of
relevant experience in designing and developing REDCap databases, developing and
implementing univariable and multivariable rules for identifying questionable
data as part of data cleaning procedures, and performing data quality assurance
of data as well as conducting data and clinical monitoring. He has utilized
REDCap for other clinical trials funded by NIH. Dr. Hessabi also trains the BERD
Graduate Research Assistants (GRAs) and supervises their work. Dr. Hessabi
understands the needs of our BERD investigators and delivers the best quality
data management support for all projects assigned to him. In addition, Dr.
Hessabi collaborates in the preparation of grants, manuscripts, abstracts, and
posters and analysis of data for manuscripts. Since 2009, he has collaborated on
39 publications and 39 abstracts and posters. In 2019, Dr. Hessabi took the lead
in writing a manuscript in collaboration with Dr. Rahbar and other members of
his research team that was published in a peer-reviewed journal. 

Dr. Hessabi’s bibliography

Amirali Tahanan, MS ([email protected])

Biostatistician

Mr. Tahanan is a bioinformatician and works as a quality-control specialist and
data analyst in BERD. Since 2010, he has been working with Dr. Rahbar and has
gained extensive experience in handling complex informatics tasks in BERD,
particularly on various NIH-funded projects. Mr. Tahanan has worked on several
data coordinating center projects and contributed to their data management
activities and data quality assurance procedures. He has worked as the data
manager for several studies, developed several secure web-based databases using
REDCap, and generated and developed several SAS programs for data cleaning and
data quality assurance of data. He has extensive experience in harmonization and
integration of multisite data that have been collected in different study sites.
In 2020, Mr. Tahanan completed his master’s degree in Biomedical Informatics
from School of Biomedical Informatics  at UTHealth with a minor in
Biostatistics. He is working as a data-quality specialist on several projects
and is responsible for many aspects of data management and data analysis,
including multivariate and longitudinal data analysis. Since 2010, he has
collaborated on several projects that led to 10 collaborative publications.

Mr. Tahanan’s bibliography


GRADUATE RESEARCH ASSISTANTS (GRAS) 

BERD provides opportunities to GRAs to gain real-life experience by applying
their theoretical knowledge in biostatistics and epidemiology to solve real-life
problems.  For example, Master’s or PhD level students who are interested in
learning about clinical studies, data management, data quality assurance, and
data analysis can get involved in various projects in BERD. Some GRAs use data
in BERD for their thesis or dissertation research and develop manuscripts in
collaboration with BERD faculty.  Current GRAs in BERD include:

 1. Sheikh F. Zaman, Epidemiology PhD candidate
 2. Ningxin Song, Biostatistics PhD candidate
 3. Qian Wang, Biostatistics PhD candidate


ONGOING BERD/DCTS PROJECTS


ADDRESSING COVID-19 TESTING DISPARITIES IN VULNERABLE POPULATIONS USING A
COMMUNITY JITAI (JUST IN TIME ADAPTATIVE INTERVENTION) APPROACH – PHASE II

3UL1TR003167 Multi-PI: Fernandez (McPherson, Fujimoto, McGaha, de Oliveira Otto,
Reininger),

09/17/2021 - 08/31/2023

NIH/NCATS

This study will leverage long-standing academic-community partnerships to
examine COVID-19 infection, testing, and vaccination patterns in three Texas
regions (Houston/Harris County, South Texas, and Northeast Texas) to identify
underserved communities. In these communities, we will provide and evaluate a
multilevel intervention to increase reach, uptake, implementation, and
sustainment of SARS-CoV-2 testing and COVID-19 vaccination. We will also explore
the impact and reach of people’s communication networks on attitudes,
intentions, and decisions on behavior regarding SARS-CoV-2 testing and COVID-19
vaccination. Dr. Rahbar serve as Co-PI and Director of the Data Management and
Statistical Analysis Core on this project. Other BERD faculty (Dr. Xu Zhang,
Co-PI and Biostatistician) and staff (Dr. Manouchehr Hessabi, Mr. Amirali
Tahanan) also contribute to the data management and statistical analysis tasks
in this study.


FEASIBILITY STUDY OF INNOVATIVE FIBER OPTIC TECHNOLOGY TO SUPPRESS INAPPROPRIATE
DISCHARGES FROM IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS (PHASE 1 STTR)

1R41HL156482 - 01A1 (Multiple PI: Cheng, Kee)   

07/01/21 – 3/31/2022 (NCE)

NIH/DHHS

The goal of this new Phase I STTR application is to integrate a fiber optic
sensor into an existing implantable cardioverter-defibrillators (ICD) system to
assess hemodynamic stability during arrhythmias to potentially prevent
inappropriate shocks (IAS). This novel design that incorporates fiber optic
sensor technology to differentiate arrhythmias with and without hemodynamic
significance to prevent IAS, would significantly impact patient morbidity and
quality of life and reduce unnecessary health care costs. Dr. Rahbar serve as
the Co-Investigator/Senior Biostatistician on this project.


EPIDEMIOLOGICAL RESEARCH ON AUTISM SPECTRUM DISORDERS (ASD) IN JAMAICA: PHASE 2

R01ES022165-01 (PI: Rahbar)

09/12/2013 - 04/30/2024

NIH/NIEHS

On this project, UTHealth collaborates with a team of multidisciplinary
researchers in the Faculty of Medical Sciences at The University of the West
Indies, Mona Campus, Kingston, Jamaica, to develop and evaluate the capacity for
creating a database of genetic and phenotypic information in Jamaica among ASD
cases and their family members. This is a population-based etiologic study of
autism in Jamaica, with a particular focus on genetic and environmental factors,
including six heavy metals (lead, mercury, arsenic, cadmium, manganese, and
aluminum), polychlorinated biphenyls, and organochlorine pesticides as
environmental contaminants and their potential interactions with the GST genes
in relation to ASD. 


RISK PREDICTION OF PROGRESSION, RECURRENCE, AND DEATH AFTER ACUTE ISCHEMIC
STROKE

R03NS111178 (PI: Rahbar)

01/01/20 - 12/31/21

NIH/NINDS

The goal of this project is to provide a better understanding of stroke
progression and recurrence by proposing an innovative and flexible joint
modeling approach for the analysis of multivariate recurrent event data. It aims
to improve the prediction accuracy of survival outcomes by combining readmission
data along with predictive markers for predictive tools development. These new
models and strategies will potentially provide valuable tools for statisticians
and clinicians in medical and health-related research focusing on risk
prediction of disease progression, recurrence, and death. Dr. Wen Li serves as a
Co-Investigator on this study.


CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES (CCTS)

UL1TR003167 (PIs: McPherson, Karp)

07/24/19-06/30/24

NIH/NCATS

The goal of the CCTS is to facilitate clinical and translational research at The
University of Texas Health Science Center at Houston, The University of Texas M.
D. Anderson Cancer Center, The University of Texas Health Science Center at
Tyler, The University of Texas – Rio Grande Valley, Rice University, and the
Memorial Hermann Hospital System, by providing resources and expert advice to
investigators. Dr. Rahbar serves as the Director of the BERD component in this
Center. Other BERD faculty also contribute to this project. 


CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES (CCTS) (ADMINISTRATIVE
SUPPLEMENT: RAD-X-UP)

UL1 TR003167-02S1 (PI: McPherson)

09/24/20 – 06/30/22

NIH/DHHS

The goal of this study is to leverage longstanding and academic-community
engaged partnership to examine SARS-CoV-2 infection patterns and identify
dynamic disease hotspots and testing deserts in racially diverse neighborhoods
of three Texas regions (Houston/Harris County, South Texas, and Northeast
Texas). This study will also evaluate the rapid adaptation and deployment of
multilevel level intervention strategies to SARV-CoV2 testing in vulnerable
populations with increased risk of severe COVID-19 infection. BERD faculty (Dr.
Xu Zhang) and staff (Dr. Manouchehr Hessabi, Mr. Amirali Tahanan, and Ms. Sori
Kim), led by Dr. Rahbar, serve as the Regional Data Coordination Center for this
study.


FEASIBILITY STUDY OF INNOVATIVE FIBER OPTIC TECHNOLOGY TO SUPPRESS INAPPROPRIATE
DISCHARGES FROM IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS (PHASE 1 STTR)

1R41HL156482 - 01A1 (Multiple PIs: Cheng, Kee)

07/01/21 – 3/31/2022

NIH/DHHS

The goal of this new Phase I STTR application is to integrate a fiber optic
sensor into an existing implantable cardioverter-defibrillators (ICD) system to
assess hemodynamic stability during arrhythmias to potentially prevent
inappropriate shocks (IAS). This novel design that incorporates fiber optic
sensor technology to differentiate arrhythmias with and without hemodynamic
significance to prevent IAS, would significantly impact patient morbidity and
quality of life and reduce unnecessary health care costs. Dr. Rahbar serves as a
Co-Investigator and biostatistician on this project. 


EXPANDED MEDICAL HOME, EXPAND PATIENT NAVIGATION, CHRONIC CARE MANAGEMENT LOWER
VALLEY, EVIDENCE BASED HEALTH PROMOTION PROGRAM (DSRIP)

10001646 Sub-in (PI:  McCormick)

01/01/18-08/31/22

CMS/DSRIP/UTHSCSA

The goal of this project is to implement medical homes in Health Professional
Shortage Areas and other rural and impoverished areas in Texas in the Lower Rio
Grande Valley. Dr. Rahbar serves as a Co-Investigator and biostatistician on
this project.


ECHOGENIC TARGETED LIPOSOMES: TRANSFECTION/DRUG DELIVERY

R01HL135092 (PI: McPherson)

04/15/17 – 03/31/22

NIH/NHLBI

The major goal of this project is to develop a carrier (echogenic
immunoliposomes) with novel ultrasound delivery methodologies that have the
ability to incorporate therapeutics and enhance delivery to stabilize
atherosclerotic beds at the time of intervention. Dr. Rahbar serves as a
Co-Investigator and biostatistician on this project.


HEMOPHILIA INHIBITOR PUP STUDY (HIPS)

X01TopMed grant (PI: Brown)

04/01/21 – 03/31/23

NIH/NHLBI/Baxter Healthcare Corporation

This is a multicenter, longitudinal and observation study that aim to assess
preventing factor VIII (FVIII) inhibitors following replacement therapies with
FVIII products in patients with hemophilia. Dr. Rahbar serve as Co-PI and
Director of the Data Management and Statistical Analysis Core on this project.
Other BERD staff (Mr. Amirali Tahanan) also contribute to the data management
and statistical analysis tasks in this study.


A PROSPECTIVE, RANDOMIZED, TRIAL OF EARLY REVASCULARIZATION IN STABLE ISCHEMIC
HEART DISEASE GUIDED BY POSITRON EMISSION TOMOGRAPHY OF ARTERY SPECIFIC
INTEGRATED COMPREHENSIVE QUANTITATIVE MYOCARDIAL PERFUSION (PETREVASC)

Multiple PIs: Rentrop, Gould

02/01/21 – 01/31/23

The objective of this pilot study is to assess the feasibility of such a trial
by comparing the impact of revascularization and optimal medical therapy (OMT)
on the extent of severely reduced coronary flow capacity (CFC). The study
focuses on extent of severely reduced CFC because it correlates with the risk of
death and myocardial infarction and has been shown to be reduced with
revascularization. Dr. Rahbar serves as Director of the Data Management Center
on this project. Other BERD staff (Dr. Manouchehr Hessabi, Mr. Amirali Tahanan)
also perform data management and data quality assurance tasks in this study.


ROAD TO DISCOVERY FOR COMBINATION PROBIOTIC BB-12 WITH LGG AT DIFFERENT DOSES IN
TREATING AUTISM SPECTRUM DISORDERS

R01HD095158 (PI: Rhoads)

07/01/19 – 06/30/23

NIH/NICHD

This clinical trial will determine the safety, tolerability, and dose of
BB-12+LGG in a Phase 1 placebo-controlled randomized trial and determine the
effect size of probiotic treatment on gastrointestinal symptoms, maladaptive
behavior, gut inflammation, and the fecal microbial community and its
metabolites.  Dr. Rahbar serve as Co-I and Director of the Data Coordination
Center on this project. Other BERD staff (Dr. Manouchehr Hessabi, Mr. Amirali
Tahanan) also perform data management and statistical analysis tasks in this
study.


SELECT 2: A RANDOMIZED CONTROLLED TRIAL TO OPTIMIZE PATIENT'S SELECTION FOR
ENDOVASCULAR TREATMENT IN ACUTE ISCHEMIC STROKE

Clinical Trial: NCT03876457 (PI: Sarraj)

06/10/19-06/09/23

Stryker, Inc.

The major goal of this project is to enroll 560 patients over 2-3 years at 30
sites and evaluate the efficacy and safety of endovascular thrombectomy compared
with medical management alone in acute ischemic stroke patients. The correlation
of imaging profiles with thrombectomy clinical outcomes and treatment effect
will be analyzed. Dr. Rahbar serve as Co-I and Director of the Data Management
Center on this project. Other BERD staff (Dr. Manouchehr Hessabi, Mr. Amirali
Tahanan) also perform data management and statistical analysis tasks in this
study.


IDENTIFICATION OF KEY TUMOR CELL-RELEASED FACTORS THAT INDUCE CACHEXIA

2R01AR063786-06A1 (Multiple PIs: Li, Jafri)

04/13/20 – 03/31/25

NIH

Cancer cachexia, characterized by muscle wasting, is seen in ~60% of cancer
patients and is a major contributor to the morbidity and mortality associated
with cancer. Cachexia is the direct cause of ~1/3 of cancer-related deaths.
Elevated circulating Hsp70 and Hsp90 are the key driving force of cancer-induced
muscle wasting and systemic inflammation and thus could be biomarkers and
therapeutic targets of cancer cachexia. Therefore, this study proposes to test
the hypothesis that tumor-released extracellular Hsp70 and Hsp90 are biomarkers
and therapeutic targets of human cancer cachexia. The project will involve a
longitudinal patient study to determine whether elevated serum Hsp70 and Hsp90
are biomarkers of human cancer cachexia that correlate with natural history of
advanced malignancies and clinical outcome. Dr. Rahbar serves as Co-Investigator
and biostatistician on this project. 


A NOVEL SURGICAL PLANNING STRATEGY FOR OPTIMAL MITRAL INTERVENTION

19TPA34860013 (PI: Govindarajan)

07/01/19-06/30/22

AHA

The goal of this project is to extend an in-house developed finite element (FE)
and fluid-structure interaction (FSI) algorithm to simulate mitral valve
function and left ventricular flow dynamics across cardiac cycle, automating the
workflow for image-FE/FSI evaluation, and create patient-specific mitral. Dr.
Rahbar serves as a Co-Investigator and biostatistician on this project.


DETECTION AND EVOLUTION OF DIFFUSELY ABNORMAL WHITE MATTER IN MULTIPLE
SCLEROSIS: A DEEP LEARNING APPROACH

1R21NS118320-01A1 (PI: Gabr)

4/1/2021-3/31/2023

NIH/NINDS

The goal of this project is to study the evolution of diffusely abnormal white
matter in multiple sclerosis and determine its relation to focal lesions. Dr. Xu
Zhang serves as a biostatistician on this project.


FEASIBILITY AND EFFECTIVENESS OF HOME-BASED TELEREHABILITATION PROGRAM FOR
RECOVERY OF UPPER LIMB FUNCTIONS IN INCOMPLETE SPINAL CORD INJURY (A
TELEREHABILITATION PROGRAM FOR SCI)

Clinical Trial: NCT04977037 (PI: Yozbatiran)

10/1/2021-9/30/2022

Mission Connect

The purpose of this study is to evaluate a telerehabilitation program that uses
remotely supervised, home-based therapy to improve upper limb voluntary movement
in adults with tetraplegia caused by incomplete spinal cord injury. Dr. Xu Zhang
serves as a biostatistician on this project.


ROLE OF HAPTOGLOBIN GENOTYPE ON NEUROINFLAMMATION AND COAGULATION FOLLOWING
ANEURYSMAL SUBARACHNOID HEMORRHAGE

K23NS106054 (PI: Blackburn)

09/15/18 - 08/31/2022

NIH/NINDS

The purpose of this research is to determine the role of the haptoglobin Hp
genotype to predict clinical outcome after aneurysmal subarachnoid hemorrhage.
Dr. Wen Li serves as a biostatistician on this project.


TARGET TUMOR MICROENVIRONMENT

W81XWH-20 (PI: Frost)

03/01/20 - 02/28/2022

NIH/NCI /DoD

Dr. Wen Li serves as a biostatistician on this project.


ROLE OF HAPTOGLOBIN GENOTYPE ON NEUROINFLAMMATION AND COAGULATION
FOLLOWING ANEURYSMAL SUBARACHNOID HEMORRHAGE

1K23NS106054-01A1 (PI: Blackburn)

9/15/2018 - 8/31/2023

NIH/NINDS

The major goal of this project is to determine if Hp genotype is a critical
determinant for outcome after aSAH via a prospective observational study,
evaluate Hp as a mediator of inflammation and coagulation, and comprehensively
investigate hypercoagulability to identify potential therapeutic targets. Dr.
Wen Li serves as a biostatistician on this project.


TARGETING THE TUMOR MICROENVIRONMENT AND METASTATIC NICHE IN BREAST CANCER

BC190383 (PI: Frost)

2/1/2020-2/28/2023

DOD

Major Goals of this project are: 1) Determine whether Net1 regulates cytokine
expression in human breast cancer and contributes to therapy resistance 2)
Characterize the ability of Net1 inhibitors to synergize with chemotherapy or
immune checkpoint therapy to block mammary gland tumorigenesis and metastasis.
Dr. Wen Li serves as a biostatistician on this project.


COMPLETED RESEARCH PROJECTS BY BERD FACULTY AND STAFF

The BERD component has successfully completed many other projects that can be
viewed here.



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 * Liaisons to the Trial Innovation Network
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 * Ethics and Advocacy
 * Grant Assistance
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