Evidence map›Paper›PMID 38710237›Full record

ReviewJournal of pharmacological and toxicological methods

Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) Cardiac Safety Committee.

Jennifer B Pierson, Brian Berridge, Ksenia Blinova, Marjory B Brooks, Sandy Eldridge, Claire E O'Brien, Michael K Pugsley, A Eric Schultze, Godfrey Smith, Norman Stockbridge and 2 more

Abstract readReview
In one paragraph

Review in Journal of pharmacological and toxicological methods. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Jennifer B PiersonHealth and Environmental Sciences Institute, Washington, DC, USA.
Brian BerridgeB2 Pathology Solutions LLC, Cary, NC, USA.
Ksenia BlinovaFood and Drug Administration, Silver Spring, MD, USA.
Marjory B BrooksComparative Coagulation Section, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY, USA.
Sandy EldridgeDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Claire E O'BrienHealth and Environmental Sciences Institute, Washington, DC, USA. Electronic address: cobrien@hesiglobal.org.
Michael K PugsleyToxicology & Safety Pharmacology, Cytokinetics, South San Francisco, CA, USA.
A Eric SchultzePathology, Lilly Research Laboratories, Indianapolis, IN, USA.
Godfrey SmithClyde Biosciences Ltd, Newhouse, UK; University of Glasgow, Scotland, UK.
Norman StockbridgeFood and Drug Administration, Silver Spring, MD, USA.
Jean-Pierre ValentinUCB Biopharma SRL, Development Science, Non-Clinical Safety Evaluation, Braine l'Alleud, Belgium.
Jose VicenteFood and Drug Administration, Silver Spring, MD, USA.

Funding

Intramural FDA HHS FD999999Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

The Health and Environmental Sciences Institute (HESI) is a nonprofit organization dedicated to resolving global health challenges through collaborative scientific efforts across academia, regulatory authorities and the private sector. Collaborative science across non-clinical disciplines offers an important keystone to accelerate the development of safer and more effective medicines. HESI works to address complex challenges by leveraging diverse subject-matter expertise across sectors offering access to resources, data and shared knowledge. In 2008, the HESI Cardiac Safety Committee (CSC) was established to improve public health by reducing unanticipated cardiovascular (CV)-related adverse effects from pharmaceuticals or chemicals. The committee continues to significantly impact the field of CV safety by bringing together experts from across sectors to address challenges of detecting and predicting adverse cardiac outcomes. Committee members have collaborated on the organization, management and publication of prospective studies, retrospective analyses, workshops, and symposia resulting in 38 peer reviewed manuscripts. Without this collaboration these manuscripts would not have been published. Through their work, the CSC is actively addressing challenges and opportunities in detecting potential cardiac failure modes using in vivo, in vitro and in silico models, with the aim of facilitating drug development and improving study design. By examining past successes and future prospects of the CSC, this manuscript sheds light on how the consortium's multifaceted approach not only addresses current challenges in detecting potential cardiac failure modes but also paves the way for enhanced drug development and study design methodologies. Further, exploring future opportunities and challenges will focus on improving the translational predictability of nonclinical evaluations and reducing reliance on animal research in CV safety assessments.

Indexed as

CardiotoxicityAcademies and InstitutesAnimalsCardiovascular DiseasesDrug DevelopmentDrug-Related Side Effects and Adverse ReactionsHumansCardiac biomarkersCardiovascularCardiovascular safetyDrug safetyNonclinical translation

Identifiers

PMID38710237
PMCPMC11318526

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.