Leading cardiology societies have issued a “call for action” on a global scale to reinvent randomized clinical trials fit for the 21st century.
“Randomized trials are an essential tool for reliably assessing the effects of treatments, but they have become too costly and too burdensome,” first author Louise Bowman, University of Oxford, United Kingdom, told theheart.org | Medscape Cardiology. “We urgently need to modernize our approach to clinical trials in order to continue to improve patient care.”
The joint opinion is from the European Society of Cardiology (ESC), the American Heart Association (AHA), the American College of Cardiology (ACC), and the World Heart Federation (WHF). It was simultaneously published online December 16 in the European Heart Journal, Circulation, Journal of the American College of Cardiology, and Global Heart.
The authors note that the availability of large-scale “real-world” data is increasingly being touted as a way to bypass the challenges of conducting randomized trials. Yet, observational analyses of real-world data “are not a suitable alternative to randomization,” Bowman said.
Cardiology has historically led the way in transforming clinical practice with groundbreaking “mega-trials,” such as the International Study of Infarct Survival (ISIS), Gruppo Italiano per lo Studio della Streptochinasi nell’Infarto (GISSI), and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
But over the past 25 years, there has been a huge increase in the rules and related bureaucracy governing clinical trials, which hinder the ability to conduct trials swiftly and affordably, the authors point out.
The COVID-19 pandemic has shown that important clinical trials can be performed quickly and efficiently in busy hospitals, they note.
“The RECOVERY trial in COVID-19 has been an excellent example of this, with results that are estimated to have saved around 1 million lives worldwide within just 1 year,” Bowman told theheart.org | Medscape Cardiology.
A Good Clinical Trials Collaborative made up of key stakeholders recently developed new guidelines designed to promote better, more efficient randomized controlled trials.
“If widely adopted and used alongside valuable 21st century electronic health records, we could transform the clinical trials landscape and do many more high-quality trials very cost-effectively,” Bowman said.
“Widespread adoption and implementation of the revised guidelines will require collaboration with a wide range of national and international organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies,” Bowman acknowledged.
“This is work that the Good Clinical Trials Collaborative is leading. It is hoped that this endorsement by the joint cardiovascular societies will increase awareness and provide valuable support to his important work,” she added.
No commercial funding was received. The authors have disclosed no relevant financial relationships.
Circulation. Published online December 16, 2022. Abstract
Eur Heart J. Published online December 16, 2022. Abstract
J Am Coll Cardiol. Published online December 16, 2022. Abstract
Global Heart. Published online December 16, 2022. Abstract
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