Research, Biostatistics

Title: A Comprehensive program for the prevention, detection and treatment of lung cancer

Sponsor: Ohio BRTT/WCI Partnership Award
Description: This is a powerful, comprehensive and synergistic partnership of four enterprises, The Ohio State University (OSU), Battelle Memorial Institute, Zivena, Inc., and Siemens Medical Solutions, whose primary objective is to catapult the attack on preventing and eradicating lung cancer while enabling sizeable commercialization within the State of Ohio for both biomedical enterprise and medical care.
Faculty: Lemeshow (Co-investigator), Jarjoura (Co-investigator)
Award P.I.: Caligiuri

Title: Adjuvant hormonal therapy in Vietnamese breast cancer

Sponsor: NIH/NCI R01
Description: The goals of this project are to 1) follow the study population to a median of approximately 7 years to further evaluate the impact on DFS and OS of i. the adjuvant therapy, ii. menstrual cycle phase at primary surgery, iii. HER-2/neu status in ER+ patients, iv. age, v. duration of signs, vi. SES, vii. reproductive risk factors, and viii. the rates of other toxicities and benefits of the adjuvant therapy; 2) evaluate in the tumors from this population biomarkers, differences in expression of which may explain the observed luteal and follicular phase oophorectomy survival differences: a proliferation maker Ki67, micro vessel density, VEGF, COX-2 expression and p53 expression; and 3) develop a decision analytic model to study adjuvant hormonal therapies in premenopausal women based on the data.
Faculty: Jarjoura (Co-investigator)
Award P.I.: Love

Title: After discharge management of low income frail elderly

Sponsor: AHRQ R 01
Description: The goal of this randomized trial is to test a care management intervention based on ACOVE guidelines to prevent decline in frail elderly.  This is a subcontract with SUMMA Health Systems of Akron, OH.
Faculty: Jarjoura (Co-investigator)
Award P.I.: Allen

Title: Analog studies of 4-HPR and its glucuronide

Sponsor: NIH/NCI R01
Description: Specific aims of program are: 1) large-scale synthesis of our most promising compounds for more detailed in vivo and in vitro studies; 2) synthesis of a limited set of stable C-linked analogs to probe structure-activity relationships; and 3) synthesis of critical radio labeled analogs to facilitate pharmacokinetic and metabolism studies and to probe the molecular mechanism of action of these compounds.
Faculty: Moeschberger (Co-investigator)
Award P.I.: Curley

Title: Analysis of longitudinal CVD & cancer data

Sponsor: NIH/National Heart, Lung and Blood Institute R01
Description: The purpose of this research is to extend and evaluate cutting edge longitudinal methods on real data sets in the areas of cardiovascular disease and cancer. One realm of exploration will be the difficulty in attributing causal effects of time-varying exposures in observational studies.  Other issues to be explored include: how to handle missing data and the fitting of growth curves.
Faculty: Lee (Co-investigator)
Award P.I.: Rosner

Title: Causal inference in observational studies via a propensity score approach

Sponsor: NICHHD R21 Subcontract
Description: The goal is to develop statistical methodology for causal inference in longitudinal observational studies and when there are unobserved confounders. Most of the studies in social sciences are observational studies and the conventional regression techniques cannot apply because of the difference in pretreatment characteristics in treated and control group. Propensity-score-matching-based methods will be developed to correct the selection bias.
Faculty: Lu (Principal Investigator)

Title: Connecting Ohio hospitals to real-time outbreak and disease surveillance system

Sponsor: Ohio Department of Health
Description: The major goal of this project is to connect additional Ohio hospitals to the RODS system.
Faculty: Shen (Principle Investigator)

Title: The convergence insufficiency treatment trial

Sponsor: NIH/NEI U01
Description: The major goals are to study the effectiveness of four treatments of convergence insufficiency.  The four treatments are 1) home-based pencil push-ups, 2) home-based pencil push-ups with computer vision therapy 3) office-based vision therapy, and 4) office-based placebo vision therapy.
Faculty: Moeschberger (Co-investigator)
Award P.I.: Mitchel

Title: Development of a metrics and measurement process for the OSU health plan

Sponsor: Center for HOPES, OSU
Description: The goal is to create a system for tracking on the system performance of OSU health plans and health care delivery to plan members; Produce information and that will support decision making by OSU leadership; Assess the costs of care and plan administration and track cost trends over time; Obtain information that will be helpful for identifying opportunities for plan improvement and designing changes to plan benefits; Conduct analyses to determine the specific factors effecting cost and performance.
Faculty: Lu (Statistician)

Title: Esophageal motility and airway protection mechanisms in infants at risk

Sponsor: NIH (NIDDK) R01
Description: The overall purpose of our study is to evaluate the causes of feeding difficulty and airway disease in infants. In this study, we plan to evaluate the movement of muscles in your child’s throat (pharynx) and food pipe (esophagus) that are normally responsible for moving the food down into the stomach, and help protect your child’s airway or food pipe. 
Faculty: Fernandez (Co-Principle Investigator) 
Award P.I.: Jadcherla

Title: Genetic and epigenetic regulation of addiction genes

Sponsor: NIH/National Institute on Drug Abuse R01
Description: We target genes harboring CpG islands that are implicated in addiction, focusing on biogenic amine pathways, encoding synthetic and catabolic enzymes, vesicular and synaptic reuptake transporters, and receptors. Our assays are allele-specific, enabling the evaluation of genetic and epigenetic factors in allelic expression, a powerful tool for assessing the quantitative impact of each factor.  This novel approach, applied to anatomically defined brain tissues from drug addicts and controls, has the potential to yield significant insight into the role of and interplay between genetic and epigenetic factors, and add to our understanding of susceptibility to addiction.
Faculty: Lee (Co-investigator)
Award P.I.: Sadee

Title: Genetic analysis of the microenvironment in breast tumor progression. Core C:  Research methods and biostatistics core.

Sponsor: NIH/NCI 1 P01
Description: The major goals are: 1) identification on a genome-wide scale of genetic alterations that occur in mammary tumor stromal cells isolated from human mammary tumor samples and the correlation of genetic changes found in mammary tumor stroma with clinical outcome of breast cancer patients; 2) experimental verification of the essential role of gene action from mammary stromal cells during mammary tumor progression.
Faculty: Lemeshow (Core C Leader), Shen (Co-investigator), Fernandez (Co-core leader)
Award P.I.: Ostrowski

Title: Implementation of a satisfaction survey process for the OSU health plans

Sponsor: Center for HOPES, OSU
Description: The goal is to evaluate employees’ satisfaction with health care received through the OSU health plans; evaluate employees’ satisfaction with the design and administration of the health plans; gauge the importance of health care and the health plans for employees’ overall satisfaction with OSU as an employer; obtain information that will be helpful for designing changes to plan benefits over the next few years; support and supplement broader metrics measurement activities, collecting survey data to provide information that is not available from other administrative data sources; design survey to allow for identifying trends over time, and benchmarking of satisfaction data with other health systems in Ohio and nationally; compare satisfaction among employee members of four OSU health plans: UPC, OSUHP, Traditional, and Buckeye.
Faculty: Lu (Statistician)

Title: Innate immunity: Elucidation/modulation - cancer therapy--Core B: Biostatistics

Sponsor: National Cancer Institute/NIH P01
Description: The overall goal is to rapidly introduce innovative clinical trials testing laboratory-based hypotheses, while pursuing additional basic investigation of innate immunity for subsequent cancer immunotherapy trials. The principal objective of the Biostatistics Core will be to provide project investigators a centralized resource for statistical expertise.  Statistical issues will be addressed at all levels of investigation: from the design of experiments, to the maintenance of data quality, and to the description and inferential statements made from the collected data.
Faculty: Lemeshow (Core Principal Investigator), Jarjoura (Director of Biostatistics Core), Shen (Senior Research Statistician)
Award P.I.: Caligiuri

Title: Luteal adjuvant oophorectomy in Vietnamese breast cancer

Sponsor: NIH/NCI 7 R01
Description: The goals of this project is to propose a new randomized, controlled trial to investigate this hypothesis in 510 Vietnamese and Filipino premenopausal women, not older than 44 years of age with regular menstrual cycles and hormone receptor-positive tumors, undergoing adjuvant surgical oophorectomy followed by tamoxifen therapy.
Faculty: Lemeshow (Co-investigator), Jarjoura (Co-investigator)
Award P.I.: Love

Title: Menthol, ethnicity and nicotine dependence

Sponsor: NIH/NIDA R01
Description: The focus of this study is to elucidate the role of ethnicity and menthol preference and to use the findings to inform future tobacco dependence treatment modalities using analyses that will include longitudinal and linear regression models as well as two-factor analysis of variance model.
Faculty: Fernandez (Co-Principle Investigator)
Award P.I.: Ahijevych

Title: Molecular analysis of the biofilm in caries and health

Sponsor: NIH/NIDCR R01
Description: This is an epidemiologic investigation using molecular microbiologic methods to study the biofilm communities associated with dental caries in children.
Faculty: Moeschberger
Award P.I.: Griffen

Title: Myopia development in children

Sponsor: NIH/NEI U01
Description: The major goals of this project are to predict the onset of myopia and to describe normal eye growth in children; this is the current funding period for this competitive renewal.
Faculty: Moeschberger (Co-investigator)
Award P.I.: Zadnik

Title: Ohio State health network infection control collaborative: Epi-centers for prevention

Sponsor: CDC U01
Description: The main goal of this grant is to look at using electronic health data for surveillance of health care associated infections.
Faculty: Lemeshow (Co-investigator), Jarjoura (Co-investigator)
Award P.I.: Stevenson

Title: Pilot exploration of zinc effects in ADHD

Sponsor: NIMH R34
Description: To develop pilot data directly from znc supplementation in attention-deficit/hyperactivity disorder (ADHD), to allow confident calculation of effect sizes and provide other information needed to design a definitive trial of zinc as treatment of ADHD, either alone or as adjunct to stimulant. Faculty: Fernandez (Co-Principle Investigator)
Award P.I.: Arnold

Title: Power and sample size for microarray studies

Sponsor: NIH/National Human Genome Research Institute R01
Description: In this project we will derive formulas for computer power and sample size for different types of hypotheses being tested in microarray studies.  We will assess the effect of experimental design and replication in terms of power for microarray studies.  We will develop software for computing power and sample size.
Faculty: Lee (Principle Investigator), Yu (Co-investigator)
Award P.I.: Lee

Title: Pulmonary, critical care and sleep medicine projects

Sponsor: College of Medicine, OSU
Description: This project aims at promoting the clinical research in the areas of critical care/hospitalized patients, Asthma, Transplantation, Sarcoidosis, Emphysema, etc. Also, the project will build the infrastructure for the ongoing clinical studies in the regards of data collection, patient monitoring, etc. Technical support on study design, data analysis and database management are provided by the Biostatisticians in the College of Public Health.
Faculty: Jarjoura (Biostatistician), Lee (Biostatistician), Lemeshow (Biostatistician), Lu (Biostatistician)

Title: Reducing cervical cancer in Appalachia

Sponsor: NIH/NCI 5 P50
Description: The principle objective of the Biostatistics and Data Resources Core will be to provide project investigators within this Center a centralized resource for statistical expertise. Statistical issues will be addressed at all levels of investigation: from the design of experiments, to the maintenance of data quality, and to the description and inferential statements made from the collected data.
Faculty: Lemeshow (Biostatistics Core Leader)
Award P.I.: Paskett

Title: Retrovirus models of lymphocyte transformation and disease

Sponsor: NIH/NCI P01
Description: The major goal of this project is to understand basic cellular mechanisms of cancer using integrated retrovirus models.
Faculty: Shen (Co-investigator), Fernandez (Biostatistics core leader)
Award P.I.: Lairmore

Title: Stromal gene expression during pulmonary sarcoidosis

Sponsor: National Heart, Lung and Blood Institute
Description: The major goal of this project is to better understand the mechanisms of sarcoidosis-induced lung inflammation using an innovative genetic profiling technique. My responsibility in this study is to develop and apply modern statistical methods for the analysis of genetic data, such as those from gene expression and proteomic studies.
Faculty: Shen (Co-Principle Investigator)

Title: Stress, the immune system and basal cell carcinoma.

Sponsor: NIH/NCI R01
Description: This study will address the interplay between psychological factors and immune function, and how this interplay may be related to immune/molecular markers associated with histopathological characteristics of BCC tumors that are relatively higher or lower in their immunoreactivity.
Faculty: Lemeshow (Co-investigator)
Award P.I.: Glaser

Title: TNF blockade in pancreatic cancer patients

Sponsor: NIH/NIDA R01
Description: The goal is to study the combination of standard chemotherapy (gemcitabine) and TNF blockade with soluble TNF receptor molecules (etanercept) in a pilot with patients with metastatic or recurrent pancreatic cancer.  We will evaluate if TNF blockade can improve the clinical benefit response, quality of life and the rate of cancer progression-free survival at six months obtained with chemotherapy.
Faculty: Fernandez (Co-Principle Investigator)
Award P.I.: Villalona-Calero

Title: The Ohio State University Comprehensive Cancer Center Support Grant

Sponsor: NIH/NCI P30
Description: To support the programs, services, research, and administration of the OSU Comprehensive Cancer Center.
Faculty: Jarjoura (Co-Director of Biostatistics Core), Lee (Statistician), Lemeshow (Shared Resource Director), Fernandez (Senior Consulting Research Statistician)
Award P.I.: Caligiuri

Title: The Ohio State University Comprehensive Cancer Center Support Grant

Sponsor: NIH/NCI P30
Description: To support the programs, services, research, and administration of the OSU Comprehensive Cancer Center.
Faculty: Lemeshow (Shared Resource Director), Jarjoura (Co-Director of Biostatistics Core), Fernandez (Senior Consulting Research Statistician)
Award P.I.: Caligiuri

Title: Threshold regression methodology for cancer risk assessment

Sponsor: National Institute of Occupational Safety and Health/CDC R01
Description: Building on preliminary work, we propose to develop a new statistical methodology for epidemiologic studies, called Threshold Regression, that will facilitate and enrich the assessment of health risks associated with occupational exposures.
Faculty: Lee (Principle Investigator)
Award P.I.: Lee

Title: Validation/Dissemination virtual temporal bone dissection

Sponsor: NIH R01
Description: To develop and validate a robust, realistic virtual environment for temporal bone dissection. Specifically this work will evaluate the efficacy of emerging simulation technologies compared to traditional methods of temporal bone dissection for training otologic surgeons.
Faculty: Fernandez (Co-Principle Investigator)
Award P.I.: Wie