# FORWARD Supplement: Common Data Elements for Food Allergy

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2023 · $519,342

## Abstract

Food allergy is one of the most common immune-mediated conditions impacting 8% of children
and 10% of adults in the US accounting for approximately 32 million Americans. Despite the
massive clinical and economic impact of food allergy (FA), our ability to disentangle the many
facets of the condition is limited by the lack of established common data elements (CDE). For
example, even though clinicaltrials.gov lists over 500 FA studies (76 actively recruiting), the
coverage of FA in the National Institutes of Health (NIH) CDE repository is minimal thus limiting
the ability of investigators to compare results across interventional and observational studies.
FORWARD is a multi-site study that systematically investigates racial and ethnic disparities
between Black, White, and Hispanic/Latino children with FA in clinical and psychosocial
outcomes, FA phenotypes and endotypes, and FA management practices. This supplement
proposes to define CDEs using a rigorous consensus-based process that will increase the impact
of the data analyses stemming from the FORWARD study. The FORWARD team of investigators
in four sites will collaborate with experts from other academic institutions, as well as additional
experts recommended by the National Institute of Allergy and Infectious Diseases (NIAID).
Building on our prior FA Data Dictionary work, we propose to identify and develop a set of CDEs
that can help provide consistency in the way FA clinical and research data are collected in
FORWARD and beyond.
Both FA diagnostics and therapies are evolving rapidly. Currently, our ability to compare various
new therapies is limited by the lack of standardized data across studies. Development of FA CDEs
will not only improve the consistency and interoperability of data in FORWARD, but also increase
the speed and quality of future FA clinical trials to advance the understanding of this immune-
mediated condition. Given the high prevalence of FA, and the impact on quality of life, accurate
and reproducible collection of FA data can be of value to many other NIH’s institutes and centers,
including the NIH Clinical Center.

## Key facts

- **NIH application ID:** 10868981
- **Project number:** 3R01AI130348-07S1
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Ruchi S Gupta
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $519,342
- **Award type:** 3
- **Project period:** 2017-05-11 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10868981

## Citation

> US National Institutes of Health, RePORTER application 10868981, FORWARD Supplement: Common Data Elements for Food Allergy (3R01AI130348-07S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10868981. Licensed CC0.

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