Most clinical trials related to the ongoing COVID-19 pandemic are not investigating the potential value of cardiovascular (CV) therapies, according to new findings published in the American Heart Journal. What would it take to get more researchers to focus on this important topic?
In early August 2020, the study’s authors searched ClinicalTrials.gov for COVID-related trials focused on various CV medications, fibrinolysis and extracorporeal membrane oxygenation (ECMO). ClinicalTrials.gov may not include all COVID-related clinical trials, but registering on that site is required by the FDA, National Institutes of Health, World Health Organization and other major organizations around the world.
“Trials evaluating CV therapies in combination with non-CV therapies were also included, as these often represent large, network-based, platform trials,” wrote first author Anubodh S. Varshney, MD, of the Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, and colleagues. “Studies evaluating anti-microbial (e.g., hydroxychloroquine, remdesivir), convalescent plasma, non-colchicine anti-inflammatory (e.g., methylprednisolone, tocilizumab), experimental, or other therapies without established CV therapies were excluded, as were studies that were withdrawn or terminated.”
Overall, out of nearly 3,000 studies, 6.9% were designed to evaluate established CV therapies and the role they may play it the management of COVID-19 patients. More than 32% of those trials were focused on antithrombotic agents, making them the most widely studied CV therapy. Pulmonary vasodilators (14%) and renin-angiotensin-aldosterone system-related therapies (12.3%) were also popular among researchers.
Most studies, the team added, occurred at a single site and were designed to enroll less than 1,000 participants.
“Findings from this report highlight the need for continued development of pragmatic, centralized randomized controlled trial infrastructures that can facilitate efficient, multi-center trials,” the authors wrote. “Integration of research into routine clinical care or established registries focusing on specific disease states, therapies, or patient populations could help establish such infrastructures. Additionally, utilization of adaptive trial designs, real-world data, and technology-based platforms for trial enrollment and execution has the potential to substantially decrease trial costs and complexity.”
Varshney et al. noted some potential opportunities for researchers. For instance, they suggested researchers with similar goals work together to “pool patient-level data upon trial conclusion and assess clinically meaningful outcomes.”
Another suggestion floated in the analysis involves increasing clinical trial sponsorship to get the industry more engaged in CV therapies.
“Outside of traditional sponsorship of patented pharmaceutical trials, corporations should consider funding trials of generic therapies in order to identify patient cohorts that may be relevant for future studies of novel therapeutics, establish collaborations with trial networks and investigators, gain insights into non-pharmacologic aspects of healthcare delivery (e.g., implementation strategies), and raise social capital,” the authors wrote. “Additionally, companies that focus predominantly on medical equipment and sensors have an opportunity to deploy new devices and technologies in such trials and learn valuable information regarding device safety and efficacy, even if the intervention formally being evaluated is a generic medication.”
The full study is available here.
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.