Projects

The INVESTED trial is an NHLBI-funded study designed to determine which of two formulations of influenza vaccine – the standard dose quadrivalent influenza vaccination or an investigational higher dose trivalent influenza vaccination – is more effective in reducing deaths and cardiopulmonary hospitalizations in individuals over 18 years of age with at least one heart disease risk factor as well as a history of heart attack (within the past year) or hospitalization for heart failure (within the past 2 years).

Principal Investigator DCC: KyungMann Kim, PhD, University of Wisconsin-Madison
Co-Principal Investigators CCC: Scott Solomon, MD, Brigham & Women’s Hospital
Orly Vardeny, PharmD, University of Minnesota
ClinicalTrials.gov Identifier: NCT02787044
Target Enrollment: 9,300
Study Start Date: August 2016
Estimated Completion Date: February 2021
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)

The INVESTED Data Coordinating Center (DCC) led by Professor Kim (DCC PI) in the UW Department of Biostatistics and Medical Informatics provides expertise and support for the INVESTED trial in data management, quality control and quality assurance, information technology for communication and trial conduct monitoring, and statistical methods for design including randomization, interim monitoring, analysis both interim and final, interpretation of findings from analysis, preparation of results in tabular and graphical formats for presentation, and publication of findings from the trial. Professor Kim oversees all DCC activities with specific responsibilities for communication and trial conduct monitoring and statistical methods; UW has partnered with the Frontier Science Foundation (https://www.frontierscience.org) for data management, quality control and quality assurance, and IT support for the INVESTED trial.

The MyHEART trial will test the effect of the MyHEART (My Hypertension Education and Reaching Target) program, a hypertension self-management intervention consisting of home blood pressure monitoring and health coaching on hypertension control and hypertension self-management behavior as compared to usual clinical care in lowering systolic and diastolic blood pressure and to examine whether MyHEART’s effects are mediated through perceived competence, autonomy, motivation and activation in young adults with uncontrolled hypertension in a randomized, multi-center, controlled trial.

Principal Investigator: Kara Hoppe, DO, University of Wisconsin-Madison
Co-Investigator, DCC Director: KyungMann Kim, PhD, University of Wisconsin-Madison
Co-Investigator: Heather Johnson, MD, MMM, FAHA, FACC, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier: NCT03158051
Target Enrollment: 310
Study Start Date: February 2018
Estimated Completion Date: April 2022
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

The MyHEART Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the MyHEART trial with limited involvement in data management which will be done using REDCap, a research electronic data capture system.

The FMT trial will test a novel intervention, fecal microbiota transplant, for treatment of C. difficile infection (CDI) in solid organ transplant recipients as compared to the standard of care oral vancomycin in reducing recurrence of CDI in a randomized, multi-center, double-blind, double-dummy controlled trial.

Principal Investigator DCC: Nasia Safdar, MD, University of Wisconsin-Madison
Co-Investigator, DCC Director: KyungMann Kim, PhD, University of Wisconsin-Madison
ClinicalTrials.gov Identifier: NCT03617445
Target Enrollment: 158
Study Start Date: February 2019
Estimated Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

The FMT Data Coordinating Center (DCC) will be led by Professor Kim. He will provide expertise and support for the FMT trial much as in the INVESTED trial in partnership with the Frontier Science Foundation for data management, quality control and quality assurance, and IT support.

The goal of the Cancer Prevention Clinical Trials Network (CP-CTNet) is to identify safe and effective preventive agents and interventions in order to advance their further clinical development for cancer prevention. The CP-CTNet Sites will perform these early phase trials supported by the NCI’s Division of Cancer Prevention and the CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC). These trials include phase 0 (micro-dosing), phase I (dose-finding), and phase II (preliminary efficacy) clinical trials. To support these early phase trials to be conducted by the CP-CTNet sites alone or as cross-Network trials, the CP-CTNet DMACC will coordinate trans-Network activities and provide expertise and resources in 1) centralized data management and reporting, 2) clinical trials auditing, and 3) administrative and logistical coordination, including expertise in clinical trials methodology and biostatistics, across CP-CTNet in partnership with the Frontier Science Foundation in Amherst, NY. In addition, the CP-CTNet DMACC will provide an advisory role in early phase cancer prevention trial development for all CP-CTNet trials and the primary statistical role for cross-Network trials.

The SHIELD Study explores the feasibility and effectiveness of safe
and cost-effective nasal povidone-iodine (PI) and oral chlorhexidine
gluconate (CHG) decontamination procedures to mitigate and prevent the
transmission of the SARS-CoV-2 virus from COVID-19 patients to health
care workers. Project Number: 27547 05/2020-04/2022

Principal Investigator(s): Dan Shirley, MD, MS, University of Wisconsin-Madison; Nasia Safdar, MD, PhD, University of Wisconsin-Madison
Co-Investigator: KyungMann Kim, PhD, University of Wisconsin-Madison
Target Enrollment: 94 Health Care Workers caring for patients with COVID-19
Study Start Date:
Estimate Completion Date:
Estimated Primary Completion Date:

The U24 Coordinating Center will (i) provide overall network coordination and facilitate scientific review of network clinical trial concepts and protocols, (ii) provide centralized support for data management for network clinical trials, and (iii) conduct independent risk-appropriate auditing of network clinical trials. The U24 Coordinating Center will serve as the organizational and coordination hub for the ‘CASCADE’ Network and is expected to provide multi-disciplinary expertise in program and operations management, clinical research informatics/information technology, and clinical trials auditing. The goal of the proposed research is to focus on the measurement of the clinical effectiveness of interventions in intended use settings while gathering crucial information informing the implementation and scale-up of such interventions across the cascade of screening and precancer treatment for women living with HIV.

Multiple Principal Investigators: Sue Siminski, MBA, MS, Frontier Science & Technology Research Foundation, Inc.; KyungMann Kim, PhD, University of Wisconsin-Madison

The DCC, will be led by KyungMann Kim and be comprised of the statistics team at the University of Wisconsin-Madison (UW) and the data management team at Frontier Science & Technology Research Foundation, Inc. (FSF). The DCC will provide expertise and resources in statistical methods, data management, Quality Management Systems (QMS), and related infrastructure maintenance for the clinical research informatics components of the DEFINE study.

The DCC statistics team will collaborate with the CCC in developing the study protocol and in assessing the requirements for data collection to address the primary and secondary objectives of the DEFINE study during the feasibility phase and will finalize the study protocol and the statistical analysis plan in year 1 of the full-scale study phase.