Scientific Sessions

Clinical Trials and Drug Development in Cardiology

Clinical trials and drug development are critical components of advancing cardiovascular medicine, providing evidence-based evaluation of new therapies, devices, and interventions. The process begins with preclinical research, including molecular, cellular, and animal studies, to assess safety and potential efficacy. Promising candidates then enter phased clinical trials: Phase I evaluates safety and dosage in healthy volunteers, Phase II assesses efficacy and side effects in a small patient population, and Phase III confirms effectiveness and monitors adverse reactions in large-scale, multicenter studies. Regulatory approval follows rigorous review, and post-marketing Phase IV trials continue to assess long-term safety and real-world outcomes.

In cardiology, clinical trials have driven major breakthroughs in the treatment of hypertension, heart failure, coronary artery disease, arrhythmias, and lipid disorders. Drug development now integrates precision medicine, targeting specific molecular pathways such as the renin-angiotensin-aldosterone system, sodium-glucose cotransporter-2 (SGLT2), and novel anti-inflammatory or lipid-lowering agents. Advanced trial designs, including adaptive trials and the use of biomarkers, imaging, and digital monitoring, have accelerated development while improving patient safety and outcome assessment. Collaborative efforts among academic institutions, industry, and regulatory bodies continue to refine the drug development process, ensuring that innovative cardiovascular therapies are both effective and safe for diverse patient populations.