# Pragmatic Approaches to Capture and Ascertainment of Clinical Trial Endpoints

> **NIH VA I01** · VA BOSTON HEALTH CARE SYSTEM · 2020 · —

## Abstract

Background and Significance:
Pragmatic approaches to the conduct of clinical trials would markedly reduce the burden on patients and the
clinical research ecosystem. Centralized capture and ascertainment of events is a major pragmatic approach
to replace local event capture and event adjudication by independent committees. An ongoing phase 4 clinical
trial sponsored by the National Heart, Lung, and Blood Institute, INfluenza Vaccine to Effectively Stop
CardioThoracic Events and Decompensated heart failure (INVESTED), in which the Veterans Affairs (VA)
Network of 34 sites led by the PI is participating, offers an ideal opportunity to develop appropriate
methodology to improve electronic medical record (EMR)-based centralized strategies for endpoint capture
and to compare central versus traditional event capture methodology.
We aim to test the hypothesis that centralized endpoint capture strategies are comparable to traditional
methods of event ascertainment utilizing the following specific aims:
Specific Aim 1. Develop algorithms for capture of major clinical trial endpoints.
We will develop methodology to capture following clinical trial endpoints from the national VA databases: all-
cause mortality, cardiovascular (CV) death, cardiopulmonary hospitalizations (CV -heart failure,
cerebrovascular events, myocardial infarction/acute coronary syndrome, arrhythmias; and pulmonary -
pneumonia, chronic obstructive pulmonary disease/chronic bronchitis, pulmonary embolism, asthma, acute
respiratory failure), and adverse reaction to vaccine (Guillain-Barre syndrome, Bell's palsy,
encephalitis/myelitis, optic neuritis, Steven-Johnson syndrome, toxic epidermal necrolysis), of enrolled
veterans by central methods. For event capture, we will identify endpoints from multiple VA and non-VA data
sources and use an iterative method to refine algorithms and will test validity of algorithms by independent
physician review and adjudication of medical records.
Specific Aim 2. Compare the event capture rate between central and traditional methods of endpoint
capture and ascertainment.
Outcomes (projected) and Anticipated impact:
We will compare event capture rates of central and traditional methods for each of the major clinical trial
endpoints described in Specific Aim 1 at the event level during each consecutive influenza season and over
the entire trial period.
We will develop methods to accurately capture major clinical trial endpoints using algorithms that will be easily
applicable to any EMR system. We also expect to find that EMR based event capture strategies are non-
inferior to traditional methods. This project will also provide significant new data about how to streamline
central approaches to achieve real-time capture and ascertainment of endpoints in clinical trials. This project is
highly significant since it will develop centralized event capture methods that will reduce the costs of
conducting clinical trials as well as the burden on patients, investiga...

## Key facts

- **NIH application ID:** 9875264
- **Project number:** 5I01CX001922-02
- **Recipient organization:** VA BOSTON HEALTH CARE SYSTEM
- **Principal Investigator:** Jacob Joseph
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2019-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9875264

## Citation

> US National Institutes of Health, RePORTER application 9875264, Pragmatic Approaches to Capture and Ascertainment of Clinical Trial Endpoints (5I01CX001922-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9875264. Licensed CC0.

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