Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges.

Data sharing Plain-language summary Preprint services Press releases Secondary analyses

Journal

European heart journal
ISSN: 1522-9645
Titre abrégé: Eur Heart J
Pays: England
ID NLM: 8006263

Informations de publication

Date de publication:
21 Oct 2023
Historique:
received: 06 03 2023
revised: 13 03 2023
accepted: 02 04 2023
pubmed: 11 5 2023
medline: 11 5 2023
entrez: 11 5 2023
Statut: ppublish

Résumé

Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.

Identifiants

pubmed: 37165687
pii: 7159836
doi: 10.1093/eurheartj/ehad279
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

4220-4229

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Déclaration de conflit d'intérêts

Conflict of interest: Zannad: Personal fees from Acceleron, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Cardior Pharmaceuticals, Cereno Scientific, Cellprothera, CVRx, G3 Pharmaceuticals, Merck, Merck AG, Novartis, NovoNordisk, Pfizer, Roche, Servier, and Vifor Fresenius; is the Co-founder of cardiorenal and Founder of CVCT. Crea: Personal fees from Amgen, Astra Zeneca, Servier, and BMS; and membership on a GlyCardial Diagnostics advisory board. Keaney: None. Spencer: None. Hill: Honoraria for institutional speaking engagements; serves as Chair on the Board of Directors for Sarnoff Research Foundation. Pfeffer: Grants or contracts paid to institution from Novartis; consulting fees from Alnylam, AstraZeneca, Boehringer Ingelheim and Eli Lilly Alliance, Corvidia, DalCor, GlaxoSmithKline, Lexicon, NHLBI CONNECTs (Master Protocol Committee), Novartis, Novo Nordisk, Peerbridge, and Sanofi; membership on Data Safety Monitoring Boards for the DELIVER (Chair, 2018–2022), TACT3a (2019-ongoing), and COLCORONA (2020–2021) studies; and stock or stock options from DalCor. Pocock: None. Raderschadt: Employment by Boehringer Ingelheim. Ross: Grants or contracts paid to institution from the US Food & Drug Administration (FDA), US National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Johnson & Johnson, Medical Devices Innovation Consortium, and Arnold Ventures; served as an expert witness in a qui tam suit against Biogen Inc.; is the co-founder of medRxiv, and serves as an Associate Research Editor at BMJ. Sacks: Employment as the Executive Editor for NEJM Evidence. Van Spall: Grants from the Canadian Institutes of Health Research (CIHR) and the Heart and Stroke Foundation (HSF). Winslow: None. Jessup: None.

Auteurs

Faiez Zannad (F)

Université de Lorraine, INSERM, CIC 1439, Institut Lorrain du Coeur et des Vaisseaux, CHU 54500, Vandoeuvre-lès-Nancy, France.

Filippo Crea (F)

Department of Cardiovascular and Pneumological Sciences, Catholic University of the Sacred Heart, Rome 00168, Italy.

John Keaney (J)

Division of Cardiovascular Medicine, Heart and Vascular Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.

Stuart Spencer (S)

The Lancet, London, EC2Y 5AS, UK.

Joseph A Hill (JA)

Department of Internal Medicine and Department of Molecular Biology, UT Southwestern Medical Center, Dallas, TX 75390, USA.

Marc A Pfeffer (MA)

Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA 02115, USA.

Stuart Pocock (S)

Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, WC1E 7HT, UK.

Emma Raderschadt (E)

Global Medical Affairs, Boehringer Ingelheim, Siegburg, 55218, Germany.

Joseph S Ross (JS)

Department of Medicine, Yale School of Medicine, New Haven, 06510, USA.

Chana A Sacks (CA)

NEJM Evidence, Waltham, MA 02451, USA.

Harriette G C Van Spall (HGC)

Department of Medicine, and Department of Health Research Methods, Evidence, and Impact, McMaster University; Population Health Research Institute; Research Institute of St. Joseph's, Hamilton, ON L8N 4A6, Canada.

Ron Winslow (R)

North Conway, NH 03860, USA.

Mariell Jessup (M)

American Heart Association, Dallas, TX 75247, USA.

Classifications MeSH