Evidence map›Paper›PMID 33258093›Full record

ArticleTherapeutic innovation & regulatory science2020

Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth.

Sarah Sheehan, Gerri Baer, Morgan Romine, Lynn Hudson, Robert Lim, Elektra Papadopoulos, Michelle Campbell, Gregory Daniel, Susan McCune

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Sarah SheehanDuke-Margolis Center for Health Policy, Washington, DC, USA. sarah.sheehan@duke.edu.
Gerri BaerU.S. Food and Drug Administration, Silver Spring, MD, USA.
Morgan RomineDuke-Margolis Center for Health Policy, Washington, DC, USA.
Lynn HudsonCritical Path Institute, Tucson, AZ, USA.
Robert LimU.S. Food and Drug Administration, Silver Spring, MD, USA.
Elektra PapadopoulosU.S. Food and Drug Administration, Silver Spring, MD, USA.
Michelle CampbellU.S. Food and Drug Administration, Silver Spring, MD, USA.
Gregory DanielDuke-Margolis Center for Health Policy, Washington, DC, USA.
Susan McCuneU.S. Food and Drug Administration, Silver Spring, MD, USA.
United States Food and Drug Administration · USCenter for Neuro-Oncology · USCritical Path Institute · US

Funding

FDA HHS U19 FD004971Intramural FDA HHS FD999999U.S. Food and Drug Administration 7U19FD004971-04
6 · The paper itself

Abstract

Chronic pulmonary and respiratory conditions associated with preterm birth are incompletely characterized, complicating long-term treatment and development of more effective therapies. Stakeholders face challenges in the development of validated, clinically meaningful endpoints that adequately measure morbidities and predict or represent health outcomes for preterm neonates. We propose in this paper a research agenda, informed by the input of experts from a 2018 workshop we convened on this topic, to advance endpoint and treatment development. We discuss the necessity of further evaluation of existing endpoints and the improved characterization of disease endotypes. We also discuss key steps to the development of optimized short- and long-term endpoints that can be linked to meaningful health outcomes. Finally, we discuss the importance of limiting variability in data collection and the application of new clinical trial endpoints as well as the critical nature of multi-stakeholder collaboration to advancing therapeutic development for this vulnerable patient population.

Indexed as

Premature BirthBronchopulmonary DysplasiaFemaleHumansInfant, NewbornInfant, PrematureMorbidityPregnancyBronchopulmonary dysplasiaChronic pulmonary insufficiency of prematurityEndpoint developmentPretermPulmonary outcomes

Identifiers

PMID33258093
PMCPMC9351457
OpenAlexW3080875559

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.