# Design-Statistical Core

> **NIH NIH U54** · BROWN UNIVERSITY · 2024 · $470,908

## Abstract

PROJECT SUMMARY
The Design/Statistics Core (DSC) will be an indispensable component of the National Institute of Aging (NIA)
Alzheimer's disease (AD)/AD-related dementia (AD/ADRD) Healthcare Systems (HCS) Collaboratory. It will
work with other Collaboratory Work Group Cores and Teams to develop knowledge and provide guidance to
conduct rigorous embedded pragmatic clinical trials (ePCTs) to improve the care and health outcomes of
persons with dementia (PWD) and their caregivers (CGs). It will serve as a national resource providing
biostatistical expertise to Collaboratory-supported pilot studies, career development awardees (CDAs), and
other NIA-funded investigators conducting such trials. The DSC will contribute to all aspects of the design,
conduct, and analysis of these projects, and will develop novel statistical methodology for the design and
analysis of ePCTs conducted among PWD within HCS. To advance this field and create a durable knowledge
repository, the Design/Statistics Core will provide guidance in areas such as: 1) robust design of ePCTs, 2)
statistical analysis of ePCTs, 3) methods for handling missing data, contamination, and other irregularities, 4)
strategies for dealing with pitfalls of specific relevance to AD/ADRD, 5) replicability and reproducibility, 6)
multiplicity and multiple comparisons, 7) consideration of under-represented minorities and important
subgroups, including treatment of sex as a biological variable, 8) documentation and dissemination of software
and analytic code, 9) publication and dissemination, and 10) training and mentoring of junior quantitative
scientists and clinical investigators. The Design/Statistics Core’s other main function will be to provide
consultation and services to the AD/ADRD Collaboratory as a whole and particularly to the pilot studies,
career, CDA recipients, and other NIA-funded investigators. The work of the DSC will be enabled by the
leadership of Dr. Heather Allore PhD, Professor of Medicine in the Yale School of Medicine, and Professor of
Biostatistics at the Yale School of Public Health, and Director of the Yale Alzheimer's Disease Research
Center's Data Management and Statistics Core. She is an experienced trialist and founder of the field of
Gerontological Biostatistics. Dr. Allore will be joined by a team of six exceptional Executive Committee
members who bring varied expertise in AD/ARDR research, aging research, cluster randomized trials, and the
conduct of ePCTs in older persons. The DSC’s Aims are: Aim 1: To provide biostatistical assistance and
guidance to Collaboratory pilot studies, CDAs recipients and NIA-funded investigators planning or conducting
ePCTs in PWD and CG; Aim 2: To develop novel biostatistical approaches, and create and disseminate
guidance documents and products relevant to the design and conduct of ePCTs in PWD with HCS, Aim 3: To
work with the Technical/Data Core, to establish and manage access to and sharing of administrative data (e.g.,
electronic he...

## Key facts

- **NIH application ID:** 11092541
- **Project number:** 3U54AG063546-05S2
- **Recipient organization:** BROWN UNIVERSITY
- **Principal Investigator:** Heather Gwynn Allore
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $470,908
- **Award type:** 3
- **Project period:** 2019-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11092541

## Citation

> US National Institutes of Health, RePORTER application 11092541, Design-Statistical Core (3U54AG063546-05S2). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11092541. Licensed CC0.

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