科研之友
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摘要
Regulatory agencies, professional societies, and clinical trialists commonly base judgments of treatment benefit on separate assessments of efficacy and safety. When separate assessments were compared with an integrated assessment using a kinetic model of a hypothetical randomized trial of antiplatelet agents in patients with acute coronary syndrome, the former showed treatment A to be superior to treatment B, whereas the latter showed treatment B to be superior to treatment A. In conclusion, comparative judgments regarding the balance between efficacy and safety depend on the model chosen for analysis; kinetic models are particularly suited to the integrated assessment of efficacy and safety relative to regulatory decisions, public policy, guideline development, and clinical care.
- 出版日期2014-11-1
