About

Purpose

The purpose of Prepare-NS is to develop and validate publicly available clinical outcome assessments (COAs) of fluid overload (FO) fit for drug development for a range of nephrotic syndrome (NS) inducing rare chronic kidney disorders.

Purpose

Core Team

Debbie Gipson, MS, MD

Professor of Pediatrics, Division of Nephrology, University of Michigan is an epidemiologist and clinical trialist with a research focus on nephrotic syndrome (NS). In this project she will provide leadership of the UG3 planning and stakeholder engagement activities, serve as the liaison with the NIH sponsored consortia, NEPTUNE and CureGN, during study design and lead the implementation of multisite study procedures leveraging the NEPTUNE and CureGN infrastructure during the UH3 phase.

She is co-PI with Dr. Peipert.

John ("Devin") Peipert, PhD

Assistant Professor, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine is a patient reported outcomes (PRO) researcher and psychometrician who works on the development and validation of PRO Clinical Outcome Assessments (COAs) that are essential to understanding patients’ functionality, symptoms, and well-being using advanced psychometric methods. In this study, he will lead the quantitative study design and execution, psychometric analyses, and quantitative data interpretation in both the UG3 and UH3 phases. He is co-PI with Dr. Gipson.

Noelle Carlozzi, MS, PhD

The director of the Center for Clinical Outcomes Development and Application in the Department of Physical Medicine and Rehabilitation and the Center for Health, Policy and Innovation (IHPI) within the University of Michigan (UM) Medical School. Her research focuses on outcomes measurement development and the examination of psychometric properties of standardized tests.

Jin-Shei Lai, PhD

Professor, Departments of Medical Social Sciences and Pediatrics, Northwestern University Feinberg School of Medicine, is a patient-centered-outcomes researcher and a registered occupational therapist with extensive experience in measurement, psychometrics, instrument development, and symptom management in people with chronic conditions. Dr. Lai uses mixed qualitative and quantitative methods to conduct clinically relevant research.

Eloise Salmon, MD

Clinical Assistant Professor in the Division of Pediatric Nephrology at the University of Michigan. She sees patients with a range of kidney care needs, including dialysis and transplant. Her research focuses on resource utilization and family experience. She completed her residency and fellowship training at the Children’s Hospital of Philadelphia.

Catherine Spino, ScD

Research Professor of Biostatistics, University of Michigan School of Public Health has over 30 years of clinical trials experience in industry and academia in many therapeutic areas. She has brought her biostatistical and clinical trials expertise to many research projects with Dr. Gipson and other investigators on the Prepare-NS project, including a recent clinical trial in FSGS, clinical trial design issues in rare diseases and NS in particular, development work on FSGS PROs, and endpoint development in NS using NEPTUNE data.

Courtney Hurt, MSW

Project Manager in the Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, where she manages PRO measure development and implementation projects. Ms. Hurt will provide Project Management support for the Prepare-NS grant.

Becky Scherr, MA

Research Area Specialist Intermediate in the Department of Pediatrics-Nephrology at the University of Michigan and will be serving as a project manager on the Prepare-NS study.

Shawn Sullivan, BS

Research Area Specialist Associate in the Department of Pediatrics-Nephrology at the University of Michigan and will be part of the data collection efforts for the Prepare-NS Study.

Kayla Sifre, BA

Research Area Specialist Associate in the Department of Pediatrics-Nephrology at the University of Michigan and will be part of the data collection efforts for the Prepare-NS Study.

Richard Eikstadt, BSEE

Senior Data Architect in the Department of Pediatrics-Nephrology. He will be providing programming, data management, and technical expertise to the Prepare-NS study.

Committees

The Extrenal Technical Advisory Committee (ETAC)

The External Technical Advisory Committee (ETAC) represents the foremost experts on Core Outcomes Assessment (COA) development and evaluation for regulatory use. They play an active role in guiding scientific aspects of the project, guiding logistical and programmatic elements, and participate in Planning, Evaluation/Validation, and Dissemination project phases.

The Clinical Expert Panel (CEP)

The Clinical Expert Panel (CEP) will participate in scheduled meetings and opportunities for electronic input. The panel will respect an open dialogue and make decisions by consensus. The group will also participate in evaluation of the Clinician Engagement approach, so that improvements to maximize contributions from all participants can be realized.

The Stakeholder Engagement Group (SEG)

The Stakeholder Engagement Group (SEG) is comprised of patients and caregivers, as well as representatives with drug development, patient-centered science, patient advocacy and engagement, payer, and clinical expertise. The group will participate in scheduled meetings and opportunities for electronic input. The panel will respect an open dialogue and make decisions by consensus. The group will also participate in evaluation of the stakeholders , so that improvements to maximize contributions from all participants can be realized.

Core Team

Committees

About

Purpose​

Core Team

Committees

Purpose