Marc P. Bonaca MD, MPH , Ninian N. Lang MBChB, PhD , Alice Chen MD , Laleh Amiri-Kordestani MD , Leslie Lipka MD, PhD , Michal Zwiewka MD , Colette Strnadova PhD , Sigrid Klaar MD, PhD , Susan Dent MD , Tijana Krnjeta Janicijevic PharmD, PhD , Joerg Herrmann MD , Ana Barac MD, PhD , Rudolf A. de Boer MD , Anita Deswal MD, MBBS, MPH , Morten Schou MD , Tomas G. Neilan MD, MPH , Peter van der Meer MD , Javid Moslehi MD , Lavanya Kondapalli MD , Bonnie Ky MD, MSCE , Mark C. Petrie MD
{"title":"Cardiovascular Safety in Oncology Clinical Trials","authors":"Marc P. Bonaca MD, MPH , Ninian N. Lang MBChB, PhD , Alice Chen MD , Laleh Amiri-Kordestani MD , Leslie Lipka MD, PhD , Michal Zwiewka MD , Colette Strnadova PhD , Sigrid Klaar MD, PhD , Susan Dent MD , Tijana Krnjeta Janicijevic PharmD, PhD , Joerg Herrmann MD , Ana Barac MD, PhD , Rudolf A. de Boer MD , Anita Deswal MD, MBBS, MPH , Morten Schou MD , Tomas G. Neilan MD, MPH , Peter van der Meer MD , Javid Moslehi MD , Lavanya Kondapalli MD , Bonnie Ky MD, MSCE , Mark C. Petrie MD","doi":"10.1016/j.jaccao.2024.09.014","DOIUrl":null,"url":null,"abstract":"<div><div>The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. Traditional approaches to clinical trial safety evaluation have limitations in their ability to detect signals of cardiovascular risk. Mechanisms to increase power and specificity to clarify cardiovascular safety are required. However, implications include increased costs and slower development. The Cardiovascular Safety Research Consortium facilitated stakeholder discussions with representation from academia, industry, and regulators. A think tank was assembled with the aim of providing recommendations for improved collection and reporting of cardiovascular safety signals in oncology trials. Two working groups were formed. The first focuses on incorporation of consensus definitions of cardiovascular disease into the Common Terminology Criteria for Adverse Events used in oncology trial reporting. The second group considers methods for ascertainment and adjudication of cardiovascular events in cancer trials. The overarching aim of this primer is to improve understanding of the potential cardiovascular toxicities of cancer therapies.</div></div>","PeriodicalId":48499,"journal":{"name":"Jacc: Cardiooncology","volume":"7 2","pages":"Pages 83-95"},"PeriodicalIF":12.0000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jacc: Cardiooncology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666087324003685","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. Traditional approaches to clinical trial safety evaluation have limitations in their ability to detect signals of cardiovascular risk. Mechanisms to increase power and specificity to clarify cardiovascular safety are required. However, implications include increased costs and slower development. The Cardiovascular Safety Research Consortium facilitated stakeholder discussions with representation from academia, industry, and regulators. A think tank was assembled with the aim of providing recommendations for improved collection and reporting of cardiovascular safety signals in oncology trials. Two working groups were formed. The first focuses on incorporation of consensus definitions of cardiovascular disease into the Common Terminology Criteria for Adverse Events used in oncology trial reporting. The second group considers methods for ascertainment and adjudication of cardiovascular events in cancer trials. The overarching aim of this primer is to improve understanding of the potential cardiovascular toxicities of cancer therapies.
期刊介绍：
JACC: CardioOncology is a specialized journal that belongs to the esteemed Journal of the American College of Cardiology (JACC) family. Its purpose is to enhance cardiovascular care for cancer patients by publishing high-quality, innovative scientific research and sharing evidence-based knowledge.
The journal aims to revolutionize the field of cardio-oncology and actively involve and educate professionals in both cardiovascular and oncology fields. It covers a wide range of topics including pre-clinical, translational, and clinical research, as well as best practices in cardio-oncology. Key areas of focus include understanding disease mechanisms, utilizing in vitro and in vivo models, exploring novel and traditional therapeutics (across Phase I-IV trials), studying epidemiology, employing precision medicine, and investigating primary and secondary prevention.
Amyloidosis, cardiovascular risk factors, heart failure, and vascular disease are some examples of the disease states that are of particular interest to the journal. However, it welcomes research on other relevant conditions as well.
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