# Clinical-Component

> **NIH NIH P30** · CINCINNATI CHILDRENS HOSP MED CTR · 2024 · $59,237

## Abstract

PROJECT SUMMARY
 The overall goal of the Clinical Component of the Digestive Health Center (DHC) is to accelerate the
translation of basic research into clinical studies and trials for pediatric digestive diseases. The Clinical
Component pursues this goal with three complementary aims. In the first Aim “to provide consultation on study
design and biostatistical services for DHC investigators,” the Clinical Component makes available to DHC
investigators a web-based portal for services related to study design, statistical analysis, and result reporting.
This line of services is led by the Director of the Clinical Component and a biostatistician with expertise on
digestive disease studies. Subsidized consultation is also available through the Cincinnati Center for
Translational Science and Training and institutional Data Management and Analysis Center (DMAC), which are
staffed by statisticians and certified data analysts. In the second Aim “to provide data management and
infrastructure for implementation, monitoring, and reporting of patient-based research on digestive diseases,”
the Clinical Component makes available to DHC investigators the infrastructure for comprehensive data
management services via DMAC, REDcap and other large-data platforms. These platforms count on rigorous
security and compliance requirements for clinical and translational research. And in the third Aim “to provide
access to tissues and genomic samples for digestive disease research,” the Clinical Component partners with
the institutional biobank that is designed to facilitate patient-based research in the pediatric population. The
biobank makes it possible for DHC investigators to obtain de-identified stored tissues and relevant disease
information for approved studies. It also facilitates the development of customized biorepositories for
investigator-initiated projects and helps with submission of IRB proposals focused on studies of digestive
diseases. Biostatistical and study design consultations are a key component of the review and ranking of Pilot
and Feasibility projects to ensure that applicants use scientifically rigorous approaches when designing pre-
clinical and clinical studies. In the current funding period, the Clinical Component supported over 30 DHC
Investigators with 12,119 hours of statistical analysis, 10,775 hours of REDCap usage and support, and
access to 1,184 tissues from digestive disease organs. We are well positioned to continue to serve the needs
of DHC Investigators, integrate our services with other DHC Cores, and accelerate the translation of basic
research into clinical studies and trials for pediatric digestive diseases.

## Key facts

- **NIH application ID:** 10848312
- **Project number:** 5P30DK078392-18
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Nicholas J Ollberding
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $59,237
- **Award type:** 5
- **Project period:** 2007-08-01 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10848312

## Citation

> US National Institutes of Health, RePORTER application 10848312, Clinical-Component (5P30DK078392-18). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10848312. Licensed CC0.

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