Evidence map›Paper›PMID 36578976›Full record

ReviewPulmonary circulation2022

Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension.

Steven D Nathan, Peter Fernandes, Mitchell Psotka, Patrizio Vitulo, Lucilla Piccari, Katerina Antoniou, Sylvia M Nikkho, Norman Stockbridge

Open access · goldAbstract readReview
In one paragraph

Review in Pulmonary circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.3field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Pulmonary hypertension associated with lung diseases.The European respiratory journal · 2024
    Review
  11. Review
  12. Article
  13. Review
  14. Review
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

8 authors at 7 institutions in 5 countries.

Steven D NathanAdvanced Lung Disease and Transplant Program, Inova Heart and Vascular Institute Falls Church Virginia USA.ORCID 0000-0002-6270-1617
Peter FernandesBellerophon Therapeutics Inc., Regulatory, Safety and Quality Department Warren New Jersey USA.
Mitchell PsotkaDivision of Cardiology and Nephrology, Food and Drug Administration Silver Spring Maryland USA.
Patrizio VituloDepartment of Pulmonary Medicine, IRCCS Mediterranean Institute for Transplantation and Advanced Specialized, Therapies Palermo Sicilia Italy.ORCID 0000-0003-1699-0208
Lucilla PiccariHospital del Mar, Pulmonary Hypertension Unit, Department of Pulmonary Medicine Barcelona Catalunya, ES Spain.ORCID 0000-0002-2241-7523
Katerina AntoniouUniversity of Crete School of Medicine, Department of Thoracic Medicine Heraklion Crete Greece.ORCID 0000-0002-0283-5293
Sylvia M NikkhoGlobal Clinical Development, Bayer AG Berlin Germany.ORCID 0000-0003-1245-2656
Norman StockbridgeUS Food and Drug Administration, Division of Cardiology and Nephrology Silver Spring Maryland USA.
United States Food and Drug Administration · USBayer (Germany) · DEBellerophon Therapeutics (United States) · USInova Fairfax Hospital · USIstituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione · ITPulmonary Hypertension Association · USUniversity of Crete · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) is an attractive target for clinical trials of PH medications. There are many factors that need to be considered to prime such studies for success. The patient phenotype most likely to respond to the intervention requires weighing the extent of the parenchymal lung disease against the severity of the hemodynamic impairment. The inclusion criteria should not be too restrictive, thus enabling recruitment. The trial should be of sufficient duration to meet the chosen endpoint which should reflect how the patient feels, functions, or survives. This paper summarizes prior studies in PH-ILD and provides a framework of the type of studies to be considered. Inclusion criteria, clinical trial endpoints, and pharmacovigilance in the context of PH-ILD trials are also addressed. Through lessons learnt from prior studies, suggestions and guidance for future clinical trials in PH-ILD are also provided.

Indexed as

clinical trial designinterstitial lung diseasepulmonary hypertension

Identifiers

PMID36578976
PMCPMC9780699
OpenAlexW4311782333

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.