Open-label trials and drug registration: a European regulator's view

MeSH terms

• Bias
• Double-Blind Method*
• Drug Approval / legislation & jurisprudence
• Drug Approval / methods*
• Endpoint Determination
• European Union
• Fibrinolytic Agents / standards
• Fibrinolytic Agents / therapeutic use*
• Humans
• International Normalized Ratio
• Patient Selection
• Professional Practice
• Prospective Studies
• Randomized Controlled Trials as Topic / methods*
• Randomized Controlled Trials as Topic / standards
• Single-Blind Method
• Thrombophilia / drug therapy
• Vitamin K / antagonists & inhibitors