Key Dates

NOT-HL-21-002 - Notice of Intent to Publish a Funding Opportunity Announcement for the ARDS, Pneumonia, and Sepsis Phenotyping Consortium Clinical Centers (U01 Clinical Trial Not Allowed)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of General Medical Sciences (NIGMS)

The National Heart, Lung and Blood Institute (NHLBI) with the National Institute of General Medical Sciences (NIGMS) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Coordinating Center of a cooperative multi-site Acute Respiratory Distress Syndrome (ARDS), Pneumonia, and Sepsis Phenotyping Consortium (APS Consortium). The APS Consortium will seek to understand the heterogeneity and underlying mechanisms of critical illness syndromes and recovery, specifically in adults with ARDS, pneumonia, and sepsis, as well as the relationship and biological overlap between these syndromes. This will be accomplished through a prospective, longitudinal observational study with common data and biospecimen collection of 5,000 hospitalized adults with ARDS, pneumonia, or sepsis from hospitalization to 1 year. Approximately half of the surviving participants will have follow-up at 3, 6, and 12 months to facilitate understanding of long-term outcomes, including biological and physiological resolution of ARDS, pneumonia, and sepsis. Throughout the program’s funding period, data and biospecimens collected will be made available as a resource to the broader research community as rapidly and simply as feasible.

The Coordinating Center will be expected to have expertise in statistics, longitudinal cohort studies, informatics, data management (including imaging data), and biospecimen management, and to have demonstrable interest in developing proactive policies for sharing.

This Notice is being provided to encourage investigators with expertise and insights in the oversight and coordination of large, observational cohort studies, statistics, data/biospecimen management, and data/biospecimen sharing to begin to consider applying for this new FOA and to allow sufficient time for these potential applicants to develop meaningful collaborations and responsive projects.

This FOA and its companion FOA for Clinical Centers (see NOT-HL-21-002) are expected to be published in January 2022 with an anticipated application due date in June 2022.

NHLBI intends to utilize the U01 activity code, a cooperative agreement, for this FOA. Anticipated details of the planned FOA are provided below.

ARDS, pneumonia, and sepsis are common critical illness syndromes with substantial associated morbidity and mortality, both during the acute phase and long-term. There is substantial heterogeneity in these critical illness syndromes, and the mechanisms of acute injury and recovery in these syndromes are not well understood. The presence of significant heterogeneity within each syndrome, combined with the overlapping phenotypes between syndromes, suggests that study of critical illness syndromes in an intertwined manner may improve the understanding of mechanisms that dictate short- and long-term outcomes and enhance the identification of sub-phenotypes across syndromes. To address this need and begin to move toward precision-based therapies, the APS Consortium will conduct a longitudinal cohort study of 5,000 participants hospitalized with ARDS, pneumonia, or sepsis, and rigorously phenotype them from hospitalization to 1 year.

The NHLBI intends to establish a cooperative U01 Consortium funded for up to six years through two companion FOAs: one that solicits applications for a Coordinating Center and another to support APS Consortium Clinical Centers (see NOT-HL-21-002). Each of the Clinical Centers (made up of one main site and at least one subsite) will enroll participants in a program-wide longitudinal cohort, as well as utilize the data, imaging, and/or biospecimens collected program-wide in a Clinical Center-specific peer-reviewed scientific project. It is anticipated that each Clinical Center will enroll 40 participants in year 1 and 240 participants/year in years 2-5 for a total of 1000 participants over the project period. Approximately half of the surviving participants will have follow-up at 3, 6, and 12 months; additional data and biospecimens will be collected at the follow-up visits to facilitate understanding of biological/physiological resolution of ARDS, pneumonia, and sepsis.

The Consortium-wide observational study protocol will be determined by a Steering Committee comprised of the Clinical Center and Coordinating Center PIs and NIH program staff during the first year of the program. Each Clinical Center application will be expected to propose hypothesis-driven scientific questions that can be answered through data, imaging, and/or biospecimens collected through the Consortium-wide observational study protocol. Scientific questions may be focused on the hospital and/or post-hospital period. The questions should be focused on ARDS, pneumonia, sepsis, or the combination of or interrelatedness between these critical illness syndromes.

The Coordinating Center will be expected to have expertise in statistics, longitudinal cohort studies, informatics, data management (including imaging data), and biospecimen management, and to have demonstrable interest in developing proactive policies for sharing.

This Consortium will generate key information about the heterogeneity, underlying mechanisms, and interrelatedness of critical illness syndromes and recovery, and yield a collection of well-phenotyped clinical data, imaging, and biospecimens. Throughout the program’s funding period, data and biospecimens collected will be made available as a resource to the broader research community as rapidly as feasible. Data and biospecimens will be collected with forward-looking data sharing policies compatible with broad consent in order to enable future research studies by others, both within and outside of the Consortium. The process for sharing data and biospecimens throughout the program’s funding period will be a key deliverable of the program and is intended to be established as simply and quickly as possible, consistent with accomplishing the scientific goals and framework of the Consortium. At the end of the program, the data and biospecimens will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst and BioLINCC ) and made available for continued use by the research community.

Applications are not being solicited at this time. 

Please direct all inquiries to:

Lora Reineck, MD, MS

National Heart, Lung, and Blood Institute (NHLBI)

301-435-0222

[email protected]