Biostatistics, Epidemiology, Research Design (BERD)

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Assistance with study design, data management, quality assurance, and statistical analysis of data 

Director: Mohammad H. Rahbar, PhD - Mohammad.H.Rahbar@uth.tmc.edu - 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

Director of BERD

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 of The University of Texas Health Science Center at Houston (UTHealth) McGovern Medical School, which serves as the primary academic home for faculty in BERD.

DCTS/BERD Faculty 

Currently there are four full time faculty in DCTS/BERD:

  • Mohammad H. Rahbar, PhD

Professor of Epidemiology and Biostatistics & Director

Mohammad.H.Rahbar@uth.tmc.edu

rahbar

Dr. Rahbar’s bibliography:

https://www.ncbi.nlm.nih.gov/sites/myncbi/1HyNtkj9b-ckW/bibliography/48082922/public

  • Xu Zhang, PhD

Associate Professor of Biostatistics

Xu.Zhang@uth.tmc.edu 

Dr. Zhang’s bibliography:

https://www.ncbi.nlm.nih.gov/sites/myncbi/1ZOxySxC5wbQj/bibliography/51835713/public/

  • Resmi Gupta, PhD

Assistant Professor of Biostatistics

Resmi.Gupta@uth.tmc.edu 

Dr. Gupta’s bibliography:

https://pubmed.ncbi.nlm.nih.gov/?term=gupta%2C+resmi 

  • Wen Li, PhD

Assistant Professor of Biostatistics  

Wen.Li@uth.tmc.edu 

Dr. Li’s bibliography:

https://www.ncbi.nlm.nih.gov/myncbi/1x14yzi2tiwIs9/bibliography/public/ 

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

BERD Staff 

Manouchehr Hessabi, MD, MPH

Senior Research Associate

Manouchehr.Hessabi@uth.tmc.edu 

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:

https://www.ncbi.nlm.nih.gov/myncbi/1LABF9YwAbKQP/bibliography/public/ 

Amirali Tahanan, MS

Research Assistant III

Amirali.Tahanan@uth.tmc.edu 

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:

https://www.ncbi.nlm.nih.gov/sites/myncbi/14kzZwHvdmuUxq/bibliography/56047116/public/ 

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. Sepideh Saroukhani, MD, MS, Epidemiology PhD candidate
  2. Jing Zhang, MS, Biostatistics PhD candidate
  3. Sori Kim, BS, Biostatistics PhD student 
  4. Yuansong Zhao, MS, Biostatistics PhD candidate
  5. Sheikh Farzana Zaman, Epidemiology MPH candidate

Ongoing BERD/DCTS Projects

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. Drs. Wen Li and Resmi Gupta serve as Co-Investigators 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 faculty (Dr. Resmi Gupta, 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.

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. 

Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk (Teen-LABS)
UM1 DK095710 (PIs: Inge, Jenkins)
09/01/2016 – 08/31/2021
NIDDK

The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers. Dr. Resmi Gupta serves as a biostatistician on this project.

Level and Timing of Diabetic Hyperglycemia in Utero: The Transgenerational Effect on Adult Morbidity (TEAM Study)
R01 DK109956 (PI: Khoury)
09/01/2017 – 08/31/2022
NIDDK

Exposure to maternal diabetes mellitus, regardless of type, in utero increases the risk of obesity, insulin resistance, diabetes, renal compromise, and cardiovascular disease in offspring. The goals of this study are (1) To demonstrate the transgenerational effect of the hyperglycemic intrauterine environment on metabolic health of adult offspring of women with type 1 diabetes, by identifying sensitive gestational periods of hyperglycemia predictive of specific metabolic morbidities in the adult offspring; and (2) to demonstrate the transgenerational effect of the hyperglycemic intrauterine environment on cardiac and peripheral vascular structure and function in adult offspring of women with type 1 diabetes. Dr. Resmi Gupta serves as a 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.

Completed Research Projects by BERD Faculty and Staff

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