[Guidelines and methods for clinical investigation of drugs for treatment of stable angina pectoris].
To prove the antianginal efficacy of drugs in patients with stable angina pectoris the notice of certain criteria is necessary for the planning and performance for the clinical investigation of medicinal products. They consist of the study design, the randomization, blinding, inclusion and exclusion criteria, definition of endpoints, the performance of the study, the doses and dosing scheme, the methods of investigation, the sample size estimation and the evaluation of the results. If there will be not paid enough attention to these criteria and conditions false positive but also false negative results can arise. The criteria necessary for proving the antianginal efficacy in patients with stable angina pectoris will be presented.
Wink
Konrad
K
Medizinische Fakultät, Universität Freiburg, Freiburg/Brsg.
D000787:Angina Pectoris / Q000188:drug therapy*; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005189:False Positive Reactions; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D002317:Cardiovascular Agents