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The US-based Cardiac Safety Research Consortium has endorsed a project aimed at replacing the routine use of drugs (often the antibiotic moxifloxacin) to test for cardiac safety in clinical trials with non-pharmacological methods such as the effects of food and exercise. The project holds the promise of more efficient and patient-focused drug development as well as contributing to the WHO’s global push against antimicrobial resistance (AMR).
The QT interval, between heart contraction and recovery, is used as a measure of cardiac rhythm. A clinical trial QT assessment, also known as a thorough QT (TQT) study, is a safety study that determines if a new drug can cause abnormal heart rhythms, or arrhythmias. TQT studies are required for new molecular entities before Phase III trials.
From April 2025 the research collaboration will run an 18-month-long, multi-centre, open-label study where patients will be randomised into groups. Some will have their QT checked after a single dose of moxifloxacin. Others will have their QT checked after a standardised breakfast following on from a 10-hour fast, while another group will have their QT checked after a period of exercise (the YMCA three-minute step test). The control group will have none of these.
The study is a collaboration between Richmond, the Richmond Research Institute, GmbH, DuckFlats Pharma and regulatory bodies the Federal Drug Administration and Health Canada. As the study’s success will rely on the contribution of multiple investigators and research units, they are calling for others to join them.
Richmond CEO Jorg Taubel said: “We believe this programme could simplify how cardiac safety assessments are done. Our objective is to generate open-source data and guidance to reduce the burden on the pharmaceutical development industry and, by being able to easily integrate mandatory QT assessments into early phase clinical studies, to support the safe and expedited introduction of new drugs for patients who need them. We aim to enrol centres around the globe to ensure these non-pharmacological tests can be used anywhere in the world.”
Global research organisations interested in taking part should contact: rri@richmondresearchinstitute.org
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