Evidence map›Paper›PMID 33282181›Full record

ArticlePulmonary circulation

Clinical trial design in phase 2 and 3 trials for pulmonary hypertension.

Sylvia Nikkho, Peter Fernandes, R James White, Chunqin Cq Deng, Harrison W Farber, Paul A Corris

Abstract 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. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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  7. 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

6 authors.

Sylvia NikkhoBayer AG, Clinical Development, Berlin, Germany.
Peter FernandesBellerophon Therapeutics, Warren, NJ, USA.
R James WhiteUniversity of Rochester Medical Center, Rochester, NY, USA.ORCID https://orcid.org/0000-0003-1399-5206
Chunqin Cq DengUnited Therapeutics Corporation, Raleigh-Durham, NC, USA.
Harrison W FarberTufts Medical Center, Boston, MA, USA.
Paul A CorrisTranslational and Clinical Science Institute, Newcastle University, Newcastle upon Tyne, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article on clinical trial design incorporates the broad experience of members of the Pulmonary Vascular Research Institute's (PVRI) Innovative Drug Development Initiative (IDDI) as an open debate platform for academia, the pharmaceutical industry and regulatory experts surrounding the future design of clinical trials in pulmonary hypertension. It is increasingly clear that the design of phase 2 and 3 trials in pulmonary hypertension will have to diversify from the traditional randomised double-blind design, given the anticipated need to trial novel therapeutic approaches in the immediate future. This article reviews a wide range of differing approaches and places these into context within the field of pulmonary hypertension.

Indexed as

drug developmentpulmonary hypertensionresearch design/program evaluation/statistical modelstrials

Identifiers

PMID33282181
PMCPMC7682228

What OpenQuestion holds

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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.