Evidence map›Paper›PMID 33282190›Full record

ArticlePulmonary circulation

Novel composite clinical endpoints and risk scores used in clinical trials in pulmonary arterial hypertension.

Olivier Sitbon, Sylvia Nikkho, Raymond Benza, Chunqin Cq Deng, Harrison W Farber, Mardi Gomberg-Maitland, Paul Hassoun, Christian Meier, Joanna Pepke-Zaba, Krishna Prasad and 2 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Pulmonary circulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 15% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Treatment algorithm for pulmonary arterial hypertension.The European respiratory journal · 2024
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Using the Plasma Proteome for Risk Stratifying Patients with Pulmonary Arterial Hypertension.American journal of respiratory and critical care medicine · 2022
    Article
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 4 countries.

Olivier SitbonAssistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Université Paris-Sud, Laboratoire d'Excellence en Recherche sur le Médicament et Innovation Thérapeutique, Le Kremlin-Bicêtre, France.
Sylvia NikkhoBayer AG, Clinical Development, Berlin, Germany.
Raymond BenzaThe Ohio State University, Columbus, OH, USA.
Chunqin Cq DengUnited Therapeutics Corporation, Raleigh-Durham, NC, USA.
Harrison W FarberTufts Medical Center, Boston, MA, USA.
Mardi Gomberg-MaitlandGeorge Washington University of Medicine and Health Sciences, Washington, DC, USA.
Paul HassounJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Christian MeierBayer AG, Clinical Development, Berlin, Germany.
Joanna Pepke-ZabaRoyal Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Krishna PrasadMedicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
Werner SeegerUniversity of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany.
Paul A CorrisClinical and Translational Research Institute Newcastle University, Newcastle upon Tyne, UK.
Bayer (Germany) · DEGeorge Washington University · USJohns Hopkins University · USNewcastle University · GBPapworth Hospital NHS Foundation Trust · GBThe Ohio State University · USTufts Medical Center · USUnited Therapeutics (United States) · USUniversité Paris-Sud · FRUniversities of Giessen and Marburg Lung Center · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This manuscript on endpoints incorporates the broad experience of members of Pulmonary Vascular Research Institute's Innovative Drug Development Initiative as an open debate platform for academia, the pharmaceutical industry and regulatory experts surrounding the future design of clinical trials in pulmonary hypertension. It reviews our current understanding of endpoints used in phase 2 and 3 trials for pulmonary hypertension and discusses in detail the value of newer approaches. These include the roles of composite endpoints and how these can be developed and validated. The newer concept of risk analysis is also discussed, including how such risk scores might be utilised as endpoints in clinical trials.

Indexed as

drug developmentpulmonary arterial hypertensionrisk factorsrisk stratification and biomarkers

Identifiers

PMID33282190
PMCPMC7682238
OpenAlexW3091973945

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.