Randomized clinical trials (RCTs) are an essential step in the development of new therapies. According to a new joint statement from four of the world’s leading cardiology groups, however, the rules and regulations that govern these trials have grown too complex—and the costs require to carry them out are far too high.
The American College of Cardiology (ACC), American Heart Association (AHA), European Society of Cardiology (ESC) and World Heart Federation (WHF) all collaborated on the statement. It can be read in full in the Journal of the American College of Cardiology, Circulation, European Heart Journal and Global Heart.[1-4]
“Randomized trials are the gold-standard method for evaluating new therapies and improving patient care,” ESC President Franz Weidinger, MD, said in a prepared statement. “However, the cost and complexity of trials are becoming prohibitive. Cardiology provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernization.”
The document includes a variety of recommendations for updates that would make RCTs easier—and more cost-effective—for research teams to carry out. For example, the groups noted that hospitals were able to participate in RCTs during the COVID-19 pandemic by focusing only on essential data, leaving the collection of follow-up data to electronic health records and other helpful resources. Remote monitoring and smartphone-based data collection were also found to be helpful during the pandemic—and these are tools that could be used in many RCTs going forward, the groups wrote.
“The pandemic reinforced the value of digital technology in healthcare and demonstrated the power of partnerships in global health,” WHF President Fausto Pinto, MD, PhD, said in the same statement. “It also showed the importance of using digital tools to improve the organization, development, and implementation of clinical trials, essential to drive innovation in care and meet unexpected challenges such as a pandemic.”
“In a rapidly changing and increasingly global world, there is no excuse for clinical trials not to keep pace with recent advances,” added ACC President Edward T.A. Fry, MD.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.