Evidence map›Paper›PMID 40436529›Full record

ArticleJACC. Basic to translational science2025

Derisking Phase II Clinical Trials in Heart Failure: A Position Paper from JACC: Basic to Translational Science and the Heart Failure Collaboratory.

Douglas L Mann, G Michael Felker, Ellis F Unger, Janet T Wittes, Biykem Bozkurt, Fady I Malik, Norman Stockbridge, Benjamin R Saville, Mona Fiuzat, Christopher M O'Connor and 1 more

Abstract read
In one paragraph

Article in JACC. Basic to translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

Douglas L MannWashington University School of Medicine, St. Louis, Missouri, USA. Electronic address: dmann@wustl.edu.
G Michael FelkerDuke University Medical Center, Durham, North Carolina, USA.
Ellis F UngerHyman, Phelps and McNamara, P.C., Washington, DC, USA.
Janet T WittesFlorida Atlantic University, Boca Raton, Florida, USA.
Biykem BozkurtWinters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E. DeBakey VA Medical Center, Houston, Texas, USA.
Fady I MalikCytokinetics, Inc, San Francisco, California, USA.
Norman StockbridgeIndependent Consultant, Dickerson, Maryland, USA.
Benjamin R SavilleAdaptix Trials, LLC, Austin, Texas, USA; Vanderbilt University Medical Center, Department of Biostatistics, Nashville, Tennessee, USA.
Mona FiuzatDuke University Medical Center, Durham, North Carolina, USA.
Christopher M O'ConnorInova Heart and Vascular Institute, Falls Church, Virginia, USA.
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Phase II clinical trials play an important role in drug development, providing key data that guide decision-making for promising therapeutic candidates. An important objective of phase II is to establish proof of concept by demonstrating that the drug produces its intended biological effects in the target population. Phase II trials also evaluate pharmacokinetics, pharmacodynamics, safety, and dose-response relationships. Ultimately, the goal is to generate the evidence needed to inform go/no-go decisions for further development. However, as we will discuss, phase II studies have inherent limitations and cannot fully predict phase III outcomes. In this JACC: Basic to Translational Science and Heart Failure Collaboratory position paper, we examine the value and constraints of phase II programs, using prior examples of heart failure trials, with the goal of providing insights that will help investigators and sponsors to derisk go/no-go decisions.

Indexed as

clinical trialsheart failurephase II

Identifiers

PMID40436529
PMCPMC12235394

What OpenQuestion holds

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LicenceCC BY
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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.