# CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL Network

> **NIH NIH U01** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $3,862,851

## Abstract

Project Summary
 This proposal is a response to the RFA-HL-14-015 for the coordinating center of
the Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury
(PETAL) Network. We propose to provide leadership in the design, analysis and conduct
of the studies of the PETAL Network and to provide the infrastructure and
communications that will create a cohesive and productive group. Over the past 18
years we have served as the coordinating center of the Acute Respiratory Distress
Syndrome (ARDS) Network under the leadership of an experienced clinical trials
statistician and an acute care physician. We recently published our approach to the
statistical and logistics issues of the ARDS Network. We propose to enhance those
methods to improve performance of these activities for PETAL. Our proposal for the
PETAL network focuses on the novel challenges of prevention trials. We suggest that
the feasibility of a prevention trial depends on the choice of endpoint, in particular that
studies using mortality as the primary endpoint would not be feasible with a conventional
trial design and other clinical endpoints may be problematic. The optimal endpoint would
be the occurrence of ARDS or a measure of the clinical consequences of ARDS. The
proposal discusses the issues of cluster randomized trials and adaptive designs. We
discuss the statistical and scientific issues in creating a biomarker resource for the
PETAL Network. We also describe our proposals to increase productivity of the network
by implementing an efficient IRB review process, plans for applying a computer-assisted
technique to set network priorities, and plans for soliciting community involvement on an
ongoing basis. We describe the methods we will use to provide the needed
infrastructure (such as a remote data and trial management system) and the
coordination of all network activities: data quality control, protocol compliance, protocol
initiation, randomization, drug distribution, sample management, adverse event reporting,
statistical reporting, data dissemination, communication, and logistics.

## Key facts

- **NIH application ID:** 10129520
- **Project number:** 3U01HL123009-06S1
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** DAVID Alan SCHOENFELD
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $3,862,851
- **Award type:** 3
- **Project period:** 2020-04-15 → 2023-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10129520

## Citation

> US National Institutes of Health, RePORTER application 10129520, CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL Network (3U01HL123009-06S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10129520. Licensed CC0.

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