Projects:
 
   

Current Projects

ChiLDREN: The Childhood Liver Disease Research and Education Network
Sponsored by NIDDK

  • The Childhood Liver Disease Research and Education Network (ChiLDREN) is network of 15 clinical sites conducting clinical trials and cohort studies of children with rare liver diseases. The ChiLDREN Network was developed to support the discovery of new diagnostics, etiologic, and treatment options for children with liver disease, and those who undergo liver transplantation.

  • SABER has served as the Data Coordinating Center (DCC) for the Network since 2000. The DCC is responsible for establishing and maintaining the database of information for all ChiLDREN studies.  The DCC collaborates with clinical investigators on study design and analysis, and provides leadership in the operational aspects of the study, including database development, data entry and management, data collection forms and processes, manuals of operations, and adherence with regulatory and protocol requirements.

  • Please go to www.childrennetwork.org for more information on the Network and its studies.

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PERL: A Multicenter Clinical Trial of Allopurinol to Prevent GFR Loss in T1D
Sponsored by NIDDK

  • To study whether uric acid lowering can reduce glomerular filtration rate (GFR) loss in subjects with type 1 diabetes (T1D), the PERL Consortium is conducting a five-year, multi-center, double-blind, placebo-controlled, randomized clinical trial. Sites include the Joslin Diabetes Center, the Universities of Minnesota, Colorado, Toronto, and Michigan, Northwestern University, Albert Einstein College of Medicine, and the Steno Diabetes Center in Denmark. SABER is the DCC for this study, collaborating with clinical investigators on study design and analysis, and provides leadership in the operational aspects of the study, including database development, data entry and management, data collection forms and processes, manuals of operations, and adherence with regulatory and protocol requirements.

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ASSET: Abatacept Systemic SclErosis Trial

  • ASSET (Abatacept Systemic SclErosis Trial) is an international, placebo-controlled, double blind, randomized trial of early diffuse cutaneous systemic sclerosis (SSc). This trial assesses abatacept (Orencia®, a recombinant fusion protein consisting of the extracellular domain of human CTLA4  is FDA approved biologic medication for rheumatoid arthritis and juvenile arthritis) in patients with early diffuse SSc with less than or equal to 36 months.
    The primary outcomes are to assess improvement in skin thickness and safety. The trial is a 12 month double blind study and is followed by a 6 month open label extension. Secondary and exploratory outcomes will include changes in the patient-reported outcomes, pulmonary function tests, joint swelling and tenderness, and other laboratory measures.

    The ASSET study is led by the Investigator-sponsor, Dinesh Khanna, MD, Director of the University of Michigan Scleroderma Program and the Co-Investigator, Catherine Spino D.Sc., the Director of the University of Michigan Data Coordinating Center with support from the National Institutes of Health and Bristol-Meyer-Squibb.  

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Udall:The University of Michigan Udall Center of Excellence for Parkinson’s Disease Research

  • Congressionally authorized program (PL 105-78) established in 1997 to honor Representative Mo Udall (D-AZ)
  • Continually funded by NINDS, now with RFAs released annually
  • Specialized Centers (P50) program
  • Currently 9 Centers across the USA
    •Emory University, •Feinstein Institute for Medical Research (NY), •Johns Hopkins, •Mayo Clinic (Jacksonville), •Northwestern U, •U of Miami, •U of Michigan, •U of Pennsylvania, •U of Washington (Seattle)
  • Up to 70% of patients with Parkinson’s disease fall each year, quadrupling the rate of hip fractures, leading to extended hospitalizations, increased use of skilled nursing facilities and eventual nursing home placement.
  • UM scientists have developed breakthrough evidence that these falls, which are resistant to currently available treatments, arise from the degeneration of brain cells that use the neurochemical acetylcholine.
  • By integrating neuroimaging, behavioral and pharmacological studies in patients with Parkinson’s disease and in animal models, we aim to further dissect the relationship between falls and abnormalities in these brain cells, and to develop the data necessary to launch a clinical trial of a novel treatment for these debilitating symptoms of Parkinson’s disease.

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EVPOME
Sponsored by DoD
  • The EVPOME Large Defect and Small Defect studies are single-site, randomized, parallel-group clinical trials performed at the University of Michigan. The primary objective of the Large Defect study is to assess the safety and efficacy of EVPOME soft tissue intraoral grafting procedures compared to the dermal equivalent AlloDerm® without keratinocytes. The primary objective of the Small Defect study is to assess the safety and efficacy for use of human EVPOME for soft tissue intraoral grafting procedures compared to the "gold standard" palatal oral mucosa (POM) graft. SABER provides project management, data management, and standard reporting to the Data Safety Monitoring Board and Institutional Review Board for these trials.

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PULMONARY FIBROSIS FOUNDATION
PATIENT REGISTRY AND BIOREPOSITORY

  • The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 PFF Care Center Network (CCN) sites in the United States. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). Interstitial lung diseases (ILD) describe a diverse group of conditions where, in general, the lung tissue becomes thickened, stiff, and scarred. The medical terminology used to describe this scar tissue is fibrosis, or in the lung – pulmonary fibrosis (PF).
    The Pulmonary Fibrosis Foundation Patient Registry (PFFR) will accomplish the following specific aims:

    1. Create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research.
    1. Collect clinically obtained data to support research in improving quality of life and outcomes of patients with ILD.
    1. Collect data on the differing patterns of clinical care for patients with ILD to support research into the impact of those patterns on outcomes (including quality of life, mortality, safety profiles and others).
    1. Collect baseline and longitudinal patient reported outcome (PRO) surveys for ILD research.
    1. Improve awareness of and facilitate enrollment into clinical trials and research studies.
    1. Gather data on healthcare utilization to be combined with clinical data in support of ILD research.

    Patients who choose to participate in the Pulmonary Fibrosis Foundation Patient Registry will be offered an opportunity to participate in the PFFR Biomarker Study.
    The objective of this Biomarker study is to develop a Biorepository of serum, plasma, RNA and DNA  specimens from participants in the PFF Registry
    This PFFR Biorepository will accomplish the following specific aims:

    1. Create a collection of biologic samples from well-characterized patients with ILD for molecular, genetic, and biologic research.
    2. Correlate biologic specimens with individually-identifiable longitudinal clinical data and patient-reported outcomes for molecular, genetic, and biologic research.
    3. Provide biologic samples from patients with defined disease processes to investigators seeking to perform discovery studies in ILDs.

    Potential future research areas of interest include, but are not limited to, biomarker discovery, biomarker validation, molecular biological investigation, genetic analyses, and/or risk stratification studies.

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RESCUE: Riociguat Efficacy and Safety in SCleroderma Digital UlcErs

  • RESCUE is a multi-center randomized, double-blind, placebo-controlled pilot study to assess the efficacy and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers. The trial is a 16 week double blind study and is followed by a 16 week open label extension. Additional efficacy measures include improvement of Raynaud’s phenomenon, presence of digital ischemia requiring intravenous prostacyclin or digital gangrene or amputation, and measurement of vascular biomarkers in the plasma.  Five sites have been selected to enroll 20 participants.

  • The RESCUE study is led by the Investigator-sponsor, Dinesh Khanna, MD, Director of the University of Michigan Scleroderma Program and the Co-Investigator, Catherine Spino D.Sc., the Director of the University of Michigan Data Coordinating Center with support from Bayer.  

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RETHINC: REdefining THerapy IN early COPD
Sponsored by the National Heart Lung & Blood Institute (NHLBI)

  • RETHINC (REdefining THerapy IN early COPD) is a double-blind, placebo-controlled, randomized trial that aims to determine if current or former smokers with breathing problems despite normal breathing tests (spirometry) will benefit from the use of a bronchodilator, indacaterol/glycopyrrolate (Utibron™), for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The result of this trial will provide new fundamental clinical and therapeutic knowledge regardless of the outcome and important evidence that may contribute to the guidelines for the management of early COPD.

  • Assessment of improvement in SGRQ after 12 weeks of study participation is the primary outcome of the study.  Secondary outcomes include assessment of improvement in other patient reported outcomes (questionnaires) as well as improvement in various pulmonary function measurements.  The study is 12 weeks long, with two clinic visits. 

  • The RETHINC study is led by Investigator-sponsors Dr. Meilan K. Han (MD, MS), Associate Professor of Internal Medicine, University of Michigan Medical School and Dr. Prescott Woodruff (MD, MPH), Professor of Medicine, University of California San Francisco (UCSF) Medical School.  Dr. Wen Ye serves as the Lead Statistician and is the Associate Director of the SABER Data Coordinating Center for the RETHINC study.   Support for the study is provided by the National Heart, Lung & Blood Institute (NHLBI), the Pulmonary Trials Cooperative, Novartis and Sunovion Pharmaceuticals Inc.

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TRAIL1: Treatment for Rheumatoid Arthritis Interstitial Lung Disease

  • This study is a phase 2, randomized, double blind, placebo controlled trial of Pirfenidone for the treatment of rheumatoid arthritis associated interstitial lung disease. The primary aim of the study will assess the efficacy and safety of Pirfenidone 2403 mg/day versus placebo in patients with RA-associated ILD. The primary efficacy outcome is defined by a composite endpoint of decline from baseline in percent predicted FVC of 10% or greater or death during the 52 week treatment period. Patients will receive blinded study treatment from the time of randomization until the Week 52 Visit. There will be 270 participants from approximately 40 sites in the United States, Canada and the United Kingdom enrolled in this study.

    TRAIL1 is led by the Investigator-sponsor, Ivan Rosas, MD, of Brigham and Women's Hospital in Boston, MA, and Catherine Spino D.Sc., the Director of the University of Michigan Data Coordinating Center with support from Genentech, Inc.ials Cooperative, Novartis and Sunovion Pharmaceuticals Inc.

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Previous Projects
NOTE: SABER was formerly called BORC, the Biometrics and Outcomes Research Core.

PFDN: Pelvic Floor Disorders Network
Sponsored by NICHD and ORWH

  • The Pelvic Floor Disorders Network is a multi-center clinical program designed to study clinical and health aspects of pelvic floor disorders in women. Pelvic floor disorders include urinary incontinence, fecal incontinence, pelvic organ prolapse, and other sensory and emptying abnormalities of the lower urinary and gastrointestinal tracts. Clinical and health aspects of pelvic floor disorders include surgical and nonsurgical treatments, social and behavioral contributions, pharmacologic therapies, any outcomes from the broad array of treatments available, and prevention efforts, among others. SABER has served as the Data Coordinating Center (DCC) for the Network since 2000, collaborating with investigators on the design and analysis of clinical trials and observational studies, as well as providing project management, monitoring, IND preparation, database programming, and data management, and standard reporting to an external Advisory Board and Data and Safety Monitoring Board.

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PUPS: Preventing Urinary Tract Infections Post-Surgery
Sponsored by NIDDK

  • SABER serves as the Data Coordinating Center for this single-site randomized placebo-controlled study performed at the University of Michigan. The goal of the study is to assess the effects of cranberry capsules versus placebo capsules in reducing asymptomatic bacteriuria and urinary tract infection symptoms during the 6 weeks following short-term catheter placement after elective gynecologic surgery. SABER collaborates with investigators and provides statistical, database programming and web support to the protocol team.

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COMET: Correlating Outcomes with biochemical Markers to Estimate Time-progression in IPF
Sponsored by NHLBI

  • This study is part of a larger network of 9 sites conducting clinical trials involving Idiopathic Pulmonary Fibrosis, a progressive, fatal, fibrotic disorder of the lung. The COMET study aims to determine if biomarkers collected from blood, bronchoscopy or surgical lung biopsy specimens can be used to predict subsequent disease course. SABER provides project management, monitoring, database programming, and data management while also collaborating with investigators to provide statistical analysis for this observational study.

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BPH: Benign Prostatic Hyperplasia Registry
Sponsored by Sanofi-Aventis

  • The goal of this registry, composed of internationally-recognized statistical consultants, is to manage and analyze data and publish literature on benign prostatic hyperplasia (BPH). Up to now, lack of quality data has limited both patients and physicians in making well-informed clinical decisions due to small sample sizes, inconsistent use of outcome measures, failure to estimate complications, lack of information on secondary therapies and failure to include community based practices. BORC served as the Data Analysis and Communication Center (DACC), providing administrative, statistical, and web support to the registry, in conjunction with the investigator.

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Innate and adaptive immunity in COPD exacerbations
Sponsored by NHLBI
  • Chronic Obstructive Pulmonary Disease (COPD) is a common problem in smokers that causes intermittent periods of worsened shortness of breath, cough and increased sputum production ("exacerbations"). The goal of this study is to learn how specific parts of the immune system cause these symptoms. This information is a first step to finding more effective treatments to prevent and treat COPD exacerbations. SABER provides database and data entry support to this study.

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SCCOR-ALI: Specialized Center of Clinically Oriented Research in Translational Research In Acute Lung Injury
Sponsored by NIH
  • This study was a multi-site randomized placebo-controlled trial of recombinant GM-CSF for patients with acute lung injury. The goal was to determine the effect of treatment with GM-CSF on: 1) days free of mechanical ventilation (days 1-28) (the primary endpoint of this study), mortality, ICU stay, and incidence of ventilator-associated pneumonia; 2) physiologic variables associated with respiratory failure; 3) parameters of alveolar epithelial dysfunction; 4) alveolar macrophage function for host defense in the context of ARDS; 5) quality of life and progression to fibrosis in survivors of ARDS. BORC collaborated with investigators and provided statistical, database programming, clinical site monitoring and web support to the protocol team. Specifically, its responsibilities included: a) Organize and manage the clinical database, b) Advise on study design, sample size calculations and selection of appropriate outcome variables, c) Allow etiologic subgroup specific interpretation of molecular biologic data, d) Assist with statistical applications and data analysis.

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HEPB: Hepatitis B Virus - Orthotopic Liver Transplantation Study
Sponsored by NIDDK
  • BORC served as the Data Coordinating Center for ‘‘Prevention of Hepatitis B Recurrence after Orthotopic Liver Transplantation’’ (NIH HBV OLT) study conducted at 15 transplant centers in the Unites States. The goals of the study were to (1) determine the safety and efficacy of Lamivudine and peri-operative IV HBIG as initial prophylaxis against recurrent hepatitis B post-OLT in low-risk patient; (2) compare the safety, efficacy and cost-effectiveness of Lamivudine and IM HBIG vs Lamivudine monotherapy in the prevention of recurrent hepatitis B after the first post-transplant year in high-risk patients; and (3) establish an observational database to capture pre- and post-OLT data on all patients who receive OLT for hepatitis B.

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Prevention Study
Sponsored by NCCAM (National Center for Complementary and Alternative Medicine)

  • The Cranberry Project, also called the Prevention Study, was a 3-year study of the use of cranberry juice to reduce recurrence in women with urinary tract infections. BORC collaborated with investigators and provided statistical, database programming and web support to the protocol team.

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OSA/EPI: Effects of Treating Obstructive Sleep Apnea in Epilepsy
Sponsored by National Institutes of Neurological Disorders and Stroke
  • BORC served as the Data Coordinating Center for this multicenter randomized clinical trial. The goal of the study was to test the hypothesis that treatment of OSA in patients with epilepsy refractory to medical treatment will reduce seizure frequency. In addition, the trial assessed the impact of treating OSA on health-related quality of life and on daytime sleepiness, common concerns in epilepsy patients that are often attributed to antiepileptic medications or to frequent seizures rather than to a coexisting sleep disorder.

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National Drug Abuse Treatment Clinical Trials Network
Sponsored by the National Institute on Drug Abuse
  • The mission of the National Drug Abuse Treatment Clinical Trials Network (CTN) is: (1) To conduct studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions of therapeutic effect in rigorous, multisite clinical trials to determine effectiveness across a broad range of community-based treatment settings and diversified patient populations; and (2) To transfer the research results to physicians, providers, and their patients to improve the quality of drug abuse treatment throughout the country using science as the vehicle.

  • BORC served as the Data Coordinating Center for the Great Lakes Regional Node of the CTN that included substance abuse researchers from Wayne State University, the University of Michigan and Michigan State University in collaboration with seven Community Treatment Programs, providing statistical and data management support for 3 major studies: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification, Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy in Substance Abuse Rehabilitation Programs, and Job Seekers’ Training for Patients with Drug Dependence. In addition, BORC participated in CTN decision-making, serving on node-level and network-level committees.

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WHR: Women’s Health Registry
Sponsored by University of Michigan Health System
  • The goal of The Women's Health Registry was to facilitate women's health research by connecting health researchers with women who are interested in participating in research. BORC developed a web application to allow women to enroll in the Registry and for current Registry participants to update their health profile and contact information.

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