# Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE)

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $691,871

## Abstract

Project Abstract
Randomized controlled trials (RCTs) remain the gold standard for establishing the causal relationship between
medications and health outcomes. However, for some clinical questions RCTs may be infeasible, unethical,
costly, or generalizable to only a very narrow population. In these cases, observational studies from routinely
collected “real-world” health data (RWD) are crucial for supplementing the evidence from RCTs. RWD is
particularly useful in the context of cardiovascular outcomes, which are typically well-captured in healthcare
databases, but concern about the validity of RWD studies mitigate their impact. The purpose of this project is
to empirically evaluate the validity of RWD studies by conducting a systematic replication of a large sample of
randomized trials of cardiovascular outcomes, including both completed trials with results already available and
ongoing trials where results are not yet released, in order to ensure that validity is not influenced by the
availability of trial results. RWD studies are designed to match the corresponding RCT as closely as possible,
including exposures, outcomes, and inclusion/exclusion criteria, and RWD studies utilize a variety of design
and analysis approaches in order to provide guidance on which questions can be answered in RWD and with
which methods. As part of this project, a new meta-analysis model will be developed to model the variation in
treatment effect estimates between RCTs and RWD, combining data across RWD methodologic approaches
and across clinical questions. All treatment effect estimates for all studies, including both RCT and RWD
results, will be reported online, and the results of ongoing RCTs will be added as they become available. This
project is the first to evaluate the validity of RWD studies of cardiovascular outcomes based on empirical
performance in a large sample of clinical questions across a wide variety of epidemiologic and analytical
methods. Findings will guide investigators planning RWD studies of cardiovascular outcomes and increase
confidence in the ability of RWD studies to answer questions of importance to patients, providers, and other
stakeholders.

## Key facts

- **NIH application ID:** 10136074
- **Project number:** 5R01HL141505-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Sebastian G. Schneeweiss
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $691,871
- **Award type:** 5
- **Project period:** 2019-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10136074

## Citation

> US National Institutes of Health, RePORTER application 10136074, Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) (5R01HL141505-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10136074. Licensed CC0.

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