Instructions and methods for clinical testing of drugs for the treatment of atrial fibrillation

Abstract

Instructions and methods for clinical testing of drugs for the treatment of atrial fibrillation are the subject of this paper. Certain criteria must be considered to demonstrate the effectiveness and benefit/risk ratio of pharmacotherapy of atrial fibrillation for the planning and performance of clinical trials. These criteria include the various forms of atrial fibrillation, the corresponding definition of endpoints, the appropriate study design, randomization and blinding, and also the adequate dose, investigation methods, sample size determination, analysis, and early termination. Only the consideration of these criteria may allow an appropriate treatment decision.

Key words

Atrial fibrillation - Clinical drug testing, criteria - Clinical trials, planning and performance - Drug development, efficacy and safety

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