Cardiologists call for review of clinical trial strategy

December 20, 2022  12:45

Four of the world's leading cardiology associations-European Society of Cardiology (ESC), American Heart Association (AHA), World Heart Federation (WHF), and American College of Cardiology (ACC)-called on the scientific community to completely review clinical trial practices. An open letter from the associations is published on their Web sites.

The vast majority of new drugs and therapies today go through a multistage system of clinical trials designed to test their safety and efficacy. Typically, these are divided into three stages, with the first stage testing safety, the second stage testing efficacy, and the third stage testing drugs and therapies among a wide range of patients.

As ESC President Franz Weidinger points out, the cost of these trials, especially the third phase, is increasing, which hinders the rapid introduction of new therapies and drugs into medical practice. For this reason, scientists suggest a radical revision of the clinical trial strategy.

An example of this, experts say, already exists. Many clinical trials of COVID-19 vaccines were conducted in such a way that their organizers themselves collected only a small part of the data by observing volunteers and obtained most of the information from electronic databases of specialized health authorities, as well as with the help of digital monitoring systems.

The introduction of such an approach in cardiology and other areas of medicine, according to representatives of cardiology associations, would significantly reduce costs and speed up clinical trials. To this end, according to scientists, it is necessary to develop and adopt appropriate legal changes that would allow physicians to obtain digital data from specialized bodies when conducting reviews of therapies and medications, as well as to use new methods of monitoring patients' lives.

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