# Clinical Research Design, Epidemiology, and Biostatistics Core

> **NIH NIH U54** · BROWN UNIVERSITY · 2020 · $793,706

## Abstract

ABSTRACT – CLINICAL RESEARCH DESIGN, EPIDEMIOLOGY AND BIOSTATISTICS CORE
Use of robust study design with modern statistical and epidemiologic methods plays an essential role in
integrated, multidisciplinary research teams created to optimize the pathway from the development of new
treatments, techniques and devices in the laboratory to their application for improved diagnosis, treatment, and
prevention of disease of patients. We propose to develop the Clinical Research Design, Epidemiology, and
Biostatistics Key Component of the RI-CCTS to provide expertise and resources to facilitate research across
institutional boundaries that will increase the capacity, sophistication, and application of contemporary
analytical approaches to transform clinical and translational research in Rhode Island. The Key Component will
connect strong but isolated research units scattered throughout Brown University Alpert Medical School and its
seven affiliated hospitals, Brown School of Public Health and University of Rhode Island College of Pharmacy.
Current collaboration among these entities has relied on ad hoc analytic teams that do not interface and study
design mentoring with no unified core. As a result, methods expertise has failed to reach a broad clinical
audience, existing teams have not benefited from others' experience and new methods and tools are not
widely distributed. We aim to create a central “storefront” through which investigators could access all of the
research tools available throughout the state and research training from its renowned academic affiliates. In
order to develop this program, we propose the following three Specific Aims:
Specific Aim 1: Services & Resources: Develop an easily accessible multidisciplinary, integrated center that
provides support to clinical and translational investigators in study design as well as collection, management,
analysis, interpretation and presentation of data using procedures that ensure quality control and
reproducibility of all analyses
Specific Aim 2: Education & Mentoring: Develop and offer training materials in study design, epidemiology
and biostatistics for early and mid-career investigators as well as provide training in statistical collaboration and
consultation for core statistical staff and student consultants
Specific Aim 3: Tools & Method Development: Provide a supportive environment to enable clinical
investigators and statistical analysts to develop, validate and disseminate innovative design and analytical
methodology arising from clinical and translational research problems
The proposed Key Component will transform clinical and translational research in Rhode Island by creating
universal access to critical expertise, tools and resources. This access will reach young investigators receiving
Pilot Awards and clinicians in isolated environments. It will train young methodologists in research collaboration
and provide young and old with a wider range of problems on which to develop and test...

## Key facts

- **NIH application ID:** 9957177
- **Project number:** 5U54GM115677-05
- **Recipient organization:** BROWN UNIVERSITY
- **Principal Investigator:** CHRISTOPHER H. SCHMID
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $793,706
- **Award type:** 5
- **Project period:** — → 2021-08-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9957177

## Citation

> US National Institutes of Health, RePORTER application 9957177, Clinical Research Design, Epidemiology, and Biostatistics Core (5U54GM115677-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9957177. Licensed CC0.

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