# An evaluation of composite endpoints using data from the EXCITE trial

> **NIH NIH R03** · UNIVERSITY OF VIRGINIA · 2024 · $80,750

## Abstract

In many clinical trials that assess the effect of an intervention, a single outcome does
not adequately capture the effect of the intervention. In these cases, a composite
outcome that combines information from several individual outcomes may be preferable.
Although there have been a number of statistical tests proposed for composite
outcomes, these methods tend to focus on the technical issues of maintain the type I
error rate and the effects on statistical power. These are important considerations for
designing trials, but do not address other key aspects, such as the characteristics of
individual outcomes that would make up a clinical relevant composite measure. This
proposal is in response to a Notice of Special Interest for using NICHD data resources in
secondary data analyses. The proposal will do secondary analyses of the data from the
EXCITE trial, available on the NICHD Data and Specimen Hub (DASH), to investigate
the proposed statistical methods with actual clinical trial data, and to gain insight into the
characteristics of individual outcomes that combine into a relevant composite outcome.

## Key facts

- **NIH application ID:** 10824347
- **Project number:** 5R03HD111715-02
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Mark R Conaway
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $80,750
- **Award type:** 5
- **Project period:** 2023-04-10 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10824347

## Citation

> US National Institutes of Health, RePORTER application 10824347, An evaluation of composite endpoints using data from the EXCITE trial (5R03HD111715-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10824347. Licensed CC0.

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