# Clinical Research & Study Design Core

> **NIH NIH P30** · BAYLOR COLLEGE OF MEDICINE · 2024 · $189,002

## Abstract

PROJECT SUMMARY/ABSTRACT: Study Design and Clinical Research Core (Clinical Core)
The major functions of the Study Design and Clinical Research Core of the Texas Medical Center Digestive
Disease Center (DDC) are to (1) serve clinical and basic science investigators in digestive diseases with
comprehensive study design consultation and support, (2) assist DDC investigators in all aspects of the
acquisition of clinical specimens required for their research in digestive diseases, (3) develop disease-specific
databases and repositories, and support comprehensive data analyses and interpretation of basic, translation,
clinical and epidemiological studies. The Specific Aims of this core are to successfully execute these functions.
Major Core services include: providing study-design and statistical-analysis support; establishing procedures for
data management and database organization to facilitate efficient analyses; assisting DDC investigators in
acquiring clinical specimens needed for their research; assisting and training in compliance, patient
confidentiality and oversight issues, including preparation of IRB requests and preparation of Investigational New
Drug applications; and educating members via meetings and seminars.
Achievements during the current funding period include the expansion of sample and tissue collection and
banking, and the increased number of requests involving epidemiology and health outcomes research, especially
those using electronic databases to capture large amounts of patient information, risk factors, therapies, and
outcomes; these databases include large disease registries and healthcare claims data. The Clinical Core will
continue to support establishment of the organoid biorepository and expand the specimen collection service to
collect tissue from preneoplastic lesions.
We propose new DDC member-exclusive services that include advanced statistical analytical programs, artificial
intelligence and machine learning, and guidance with causal inference modeling. New data management
services have been integrated including REDCap, dashboards, and applications that interface with laboratory
and clinical aspects of the Core. We also anticipate the growth of demand for expertise related to health services
research in digestive diseases from newly recruited investigators and the NIDDK training program in
epidemiology and outcomes of GI diseases. The Clinical Core will also expand the specimen collection service
to collect specimens for assessing exposure to heavy metal; this new protocol is highly sought after by
investigators studying the role of heavy metals exposure in gastrointestinal and hepatic injury and inflammation.
Twenty-two DDC members used the Core during the current funding cycle, accruing more than 13,500 hours of
service. We supported 24 grant applications (30% already funded) and 200 peer-reviewed publications.

## Key facts

- **NIH application ID:** 10920369
- **Project number:** 5P30DK056338-22
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** FASIHA KANWAL
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $189,002
- **Award type:** 5
- **Project period:** 2001-04-15 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920369

## Citation

> US National Institutes of Health, RePORTER application 10920369, Clinical Research & Study Design Core (5P30DK056338-22). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10920369. Licensed CC0.

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