# Enhancing evidence generation by linking randomized clinical trials (RCTs) to real world data (RWD)

> **NIH FDA U01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $1,267,277

## Abstract

Project Summary/Abstract
Traditional randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of treatments.
However, RCTs may have missing data, may not capture all effectiveness and safety outcomes that are
important to patients, may have limited follow-up duration, and their results may not always generalizable to
diverse patient populations in real-world settings. Linking RCTs to real-world data (RWD), such as insurance
claims and electronic health record, provides a valuable opportunity to enhance traditional RCTs by
addressing these shortcomings. In this project, we propose linking RCTs to participants’ RWD using two case
studies: The INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
(INVESTED) trial and Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection
Fraction Heart Failure (DELIVER) trial. The overarching objective of this project is to use linked RCT-RWD
to develop and validate methods that can enrich both randomized and non-randomized comparative
effectiveness studies. We will use linked RCT-RWD to accomplish the following specific aims:
Aim 1. To enhance RCT findings using long-term, validated, RWD-based outcome measures.
Aim 2. To develop methods for using RWD to replace or impute missing RCT data.
Aim 3. To generalize RCT results to broader patient populations in real-world setting.
Aim 4: To develop methods to identify sources of discrepant results between RCTs and RWD-based studies.

## Key facts

- **NIH application ID:** 10250390
- **Project number:** 5U01FD007213-02
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Elisabetta Patorno
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $1,267,277
- **Award type:** 5
- **Project period:** 2020-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10250390

## Citation

> US National Institutes of Health, RePORTER application 10250390, Enhancing evidence generation by linking randomized clinical trials (RCTs) to real world data (RWD) (5U01FD007213-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10250390. Licensed CC0.

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