# Project-004

> **NIH NIH UL1** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2021 · $489,849

## Abstract

The lack of sufficient high-quality, reproducible data across clinical and translational research is creating a
major obstacle for the effective translation of basic research to improve health outcomes. This complex problem
includes inadequate study design, inefficient dissemination of research findings, inadequate patient recruitment,
suboptimal use of electronic health practices, and poor documentation practices. About two thirds of typical
errors are related to problems in the experimental design and performance. Proper study design involves a
comprehensive approach to planning, performance, documentation, analysis, and publication. The research
methods experts at UTMB play a critical role in comprehensive study design and statistical analysis, as well as
interpretation and dissemination of high-quality, ethical clinical and translational research. We have experience
across the entire translational research continuum, with particular expertise in bioinformatics, patient-centered
outcomes research/comparative effectiveness research, large database analysis, clinical trials, data mining,
and network analysis. In this research methods component we will address the major issues in clinical and
translational studies making our CTSA more effective, efficient, and making our studies easily disseminated
to improve health across the country. To accomplish this, we will provide resources to our investigators in the
areas Biostatistics, Epidemiology and Research Design. The Biostatistics Epidemiology and Research Design
group will provide researchers easy access to biostatistical education/training, research design consultation,
and innovative tools and methods to enhance the quality, rigor and efficiency of clinical and translational. The
Office of Clinical Research will provide investigators and study teams with focused regulatory knowledge and
clinical trial management support. We will support investigators with innovative tools such as developing apps
to assess data quality and data mining methods to assess pharmacotherapy-associated toxicities. We will also
apply innovative techniques to enhance trial design and to analyze the results of comparative effectiveness
research. In addition, we will develop a process to obtain electronic consent.Our Research Methods component will enhance innovation, access and quality of clinical and translational
research at UTMB. This is accomplished with tight integration between research methods, hub capacity, and
informatics. Our research methods program encompasses two integrated modules. The Biostatistics, Epidemiology
and Research Design (BERD) team is an essential component of the translational research mission at UTMB,
providing: team-based collaboration and consultation on research design and biostatistics; continuous education,
mentoring and training to students and faculty; and strong support to the informatics core. BERD will continue to
play a critical role in developing innovative research methods at UTMB...

## Key facts

- **NIH application ID:** 10141322
- **Project number:** 5UL1TR001439-07
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Randall J Urban
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $489,849
- **Award type:** 5
- **Project period:** 2015-08-18 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10141322

## Citation

> US National Institutes of Health, RePORTER application 10141322, Project-004 (5UL1TR001439-07). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10141322. Licensed CC0.

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