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

Faiez Zannad; Filippo Crea; John Keaney; Stuart Spencer; Joseph A Hill; Marc A Pfeffer; Stuart Pocock; Emma Raderschadt; Joseph S Ross; Chana A Sacks; Harriette G C Van Spall; Ron Winslow; Mariell Jessup

doi:10.1093/eurheartj/ehad279

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

Eur Heart J. 2023 Oct 21;44(40):4220-4229. doi: 10.1093/eurheartj/ehad279.

Authors

Affiliations

¹ Université de Lorraine, INSERM, CIC 1439, Institut Lorrain du Coeur et des Vaisseaux, CHU 54500, Vandoeuvre-lès-Nancy, France.
² Department of Cardiovascular and Pneumological Sciences, Catholic University of the Sacred Heart, Rome 00168, Italy.
³ Division of Cardiovascular Medicine, Heart and Vascular Center, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
⁴ The Lancet, London, EC2Y 5AS, UK.
⁵ Department of Internal Medicine and Department of Molecular Biology, UT Southwestern Medical Center, Dallas, TX 75390, USA.
⁶ Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School Boston, MA 02115, USA.
⁷ Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, WC1E 7HT, UK.
⁸ Global Medical Affairs, Boehringer Ingelheim, Siegburg, 55218, Germany.
⁹ Department of Medicine, Yale School of Medicine, New Haven, 06510, USA.
¹⁰ NEJM Evidence, Waltham, MA 02451, USA.
¹¹ 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.
¹² North Conway, NH 03860, USA.
¹³ American Heart Association, Dallas, TX 75247, USA.

PMID: 37165687
DOI: 10.1093/eurheartj/ehad279

Abstract

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.

Keywords: Data sharing; Plain-language summary; Preprint services; Press releases; Secondary analyses.