# Continuation of the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) 4

> **NIH NIH U24** · JOHNS HOPKINS UNIVERSITY · 2024 · $1,280,357

## Abstract

Project Summary/Abstract
 Since 2006, the Gastroparesis Clinical Research Consortium (GpCRC) has made advancements in the
pathogenesis, diagnosis, treatment, and clinical management of gastroparesis in adults and children. The
incidence of gastroparesis ranges from 6.3 to 17.2 cases per 100,000 person-years in adults, which is similar
to other important gastrointestinal diseases such as inflammatory bowel disease. This proposal is to continue
as the Scientific Data Research Center (SDRC) to support the clinical centers as they continue to collect data
and biospecimens for adult and pediatric patients with symptoms of gastroparesis. The SDRC includes the
Pathological Basis of Gastroparesis Study (PBG) conducted by Drs. Grover and Farrugia at the Mayo Clinic to
continue their identification of the molecular factors involved in pathogenesis of gastroparesis. Our aims for the
continuation are: 1) To complete the adult trial of Buspirone for Early Satiety and Symptoms of Gastroparesis,
the Pyloric Sphincter Abnormalities (PSAGS) study, and adult and pediatric gastroparesis registries initiated
during the previous funding cycle; 2) To develop and conduct a new adult or pediatric treatment trial; and 3) To
coordinate and implement use of a single IRB (sIRB) to oversee all ongoing and future GpCRC studies.
 The SDRC will provide leadership, expertise in biostatistical analysis, study design, data management,
multicenter coordination, quality assurance, and will be responsible for supporting all current and future
protocols, including providing sample size calculations, statistical advice, form development, data analysis and
manuscript preparation. The SDRC will support development, implementation, and maintenance of a real-time
database for each study, prepare de-identified databases to submit to the NIDDK Central Repository for public-
use and maintain a digital repository of procedure output and specimen assay or genomic data. The SDRC will
coordinate the activities and meetings of the Steering Committee (SC) and other committees, and prepare all
reports for committees including the SC and Data and Safety Monitoring Board (DSMB). The SDRC will
prepare protocols for submission to the SC, NIDDK program office, and DSMB, along with materials in support
of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications on behalf of the
NIDDK. The SDRC will support partnerships between GpCRC investigators and expert scientists to use
GpCRC resources to advance the understanding of gastroparesis. The SDRC will administer performance-
based subcontracts with clinical centers for future studies that may arise. The SDRC will coordinate the
preparation, coding and shipping of clinical center biospecimens to the NIDDK Central Repository and work
with the Repository to manage the receipt and inventory of biospecimens for storage and fulfilling investigator
specimen and data requests. The SDRC will manage the development, approval, and amendme...

## Key facts

- **NIH application ID:** 10899461
- **Project number:** 5U24DK074008-18
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** David M Shade
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,280,357
- **Award type:** 5
- **Project period:** 2006-05-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10899461

## Citation

> US National Institutes of Health, RePORTER application 10899461, Continuation of the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) 4 (5U24DK074008-18). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10899461. Licensed CC0.

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